Category Archives: Covid-19

Vaccines appear to be starting to curb new Covid-19 infections in the U.S., a breakthrough that could help people return to more normal activities as infection worries fade, public-health officials say.

By Tuesday, 37.3% of U.S. adults were fully vaccinated against Covid-19, with about 2.7 million shots each day. Data from Johns Hopkins University shows the seven-day average for new U.S. cases has fallen below the 14-day average for more than a week, which epidemiologists said is a strong signal that cases are starting to slide again after a recent upswing. When the seven-day average is higher than the 14-day average, it suggests new cases are accelerating.

With the U.S. recently averaging at least 50,000 new daily cases, the pandemic is far from over. But the U.S. is nearing a nationwide benchmark of having 40% of adults fully vaccinated, which many public-health experts call an important threshold where vaccinations gain an upper hand over the coronavirus, based on the experience from further-along nations such as Israel.

When you get to somewhere between 40 and 50%, I believe youre going to start seeing real change, the start of a precipitous drop in cases, said Anthony Fauci, the top U.S. infectious-disease expert, in an interview.

When you do, thats when people are going to be able to start doing things that theyve been craving, Dr. Fauci said about returning to more normal patterns of life. Health authorities also note that millions of unvaccinated Americans carry some protection, too, because they previously had Covid-19.

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Vaccines Appear to Be Slowing Spread of Covid-19 Infections - The Wall Street Journal

Company logo of pharmaceutical company GlaxoSmithKline is seen at their Stevenage facility, Britain October 26, 2020. REUTERS/Matthew Childs/File Photo

Plans for GSK to split in two are well underway it said on Wednesday, as a cost clampdown and rising clinic visits for critical treatments after an easing of COVID-19 curbs helped it land better-than-forecast first-quarter earnings.

GSK (GSK.L), which trails competitors in the coronavirus vaccines race, is under the microscope after a report that U.S. activist investor Elliott built up a significant stake.

The British drugmaker said it would give details on June 23 on its plan to separate next year into an over-the-counter business and another for prescription drugs and vaccines.

Chief Executive Emma Walmsley said she was focused on GSK's broader transformation, adding that while GSK's consumer health business had great prospects and a "fantastic" leadership team, she would focus on the bigger picture.

Walmsley, a former head of GSK's consumer business, became CEO in 2017 despite some investor pressure to name an outsider and such calls may grow with Elliott's arrival on the register.

"I'm very focused on leading GSK through that successful separation and beyond," Walmsley told journalists without naming the activist fund, adding that she saw her role as CEO as setting strategy, hiring top people and allocating capital, while leaving the medical science to the experts.

R&D LEADERSHIP

"I've clearly laid (strategy) out from day one ... and included in that has been the best possible R&D leadership in the world," Walmsley said in response to suggestions that her lack of scientific background meant she would be better suited to lead the consumer business once GSK splits in two.

Preparations have hurt earnings, but GSK hopes the streamlining of operations will pay off in the long term.

"With or without Elliott's alternative vision, it looks set to be a year of forced evolution at GSK," said Steve Clayton, manager of Hargreaves Lansdown's Select UK Income Shares fund.

GSK said that turnover for the quarter to March fell 15% to 7.42 billion pounds ($10.28 billion) at constant currency rates, as the year-earlier period was inflated by people stocking up on medicines because of the pandemic.

In addition, sales of cold and flu remedies like Theraflu or Robitussin fell because social distancing prevented infections, mirroring the experience at Sanofi (SASY.PA) and Novartis (NOVN.S).

Adjusted earnings were 22.9 pence per share, down by a third, compared to analysts' expectation of 21.9 pence per share on sales of 7.83 billion pounds.

"GSK endured a pretty lacklustre 2020 ... Worryingly, their 2021 performance looks all too familiar," Third Bridge analyst Sebastian Skeet said in a note after it stuck to its forecast of a mid-to-high single digit fall in earnings this year.

However, GSK expects its vaccines division to recover in the second half, as healthcare systems and consumer trends approach normality.

($1 = 0.7215 pounds)

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GSK focused on split as cost checks, COVID-19 easings aid earnings - Reuters

Coronavirus disease 2019 (COVID-19), also known as the coronavirus or COVID, is a contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019.[7] The disease has since spread worldwide, leading to an ongoing pandemic.[8]

Symptoms of COVID-19 are variable, but often include fever,[9] cough, headache,[10] fatigue, breathing difficulties, and loss of smell and taste.[11][12] Symptoms may begin one to fourteen days after exposure to the virus. At least a third of people who are infected do not develop noticeable symptoms.[13] Of those people who develop noticeable symptoms enough to be classed as patients, most (81%) develop mild to moderate symptoms (up to mild pneumonia), while 14% develop severe symptoms (dyspnea, hypoxia, or more than 50% lung involvement on imaging), and 5% suffer critical symptoms (respiratory failure, shock, or multiorgan dysfunction).[14] Older people are at a higher risk of developing severe symptoms. Some people continue to experience a range of effects (long COVID) for months after recovery, and damage to organs has been observed.[15] Multi-year studies are underway to further investigate the long-term effects of the disease.[15]

Transmission of COVID-19 occurs mainly when an infected person is in close contact[a] with another person.[19][20] Small droplets containing the virus can spread from an infected person's nose and mouth as they breathe, cough, sneeze, sing, or speak. Other people are infected if the virus gets into their mouth, nose or eyes. Airborne transmission is also sometimes possible, as smaller infected droplets and particles can linger in the air for minutes to hours within enclosed spaces that have inadequate ventilation.[20] Less commonly, the virus may spread via contaminated surfaces.[20] People who are infected can transmit the virus to another person up to two days before they themselves show symptoms, as can people who do not experience symptoms.[21][22] People remain infectious for up to ten days after the onset of symptoms in moderate cases and up to twenty days in severe cases.[23]

Several testing methods have been developed to diagnose the disease. The standard diagnostic method is by detection of the virus' nucleic acid by real-time reverse transcription polymerase chain reaction (rRT-PCR), transcription-mediated amplification (TMA), or by reverse transcription loop-mediated isothermal amplification (RT-LAMP) from a nasopharyngeal swab.

Preventive measures include physical or social distancing, quarantining, ventilation of indoor spaces, covering coughs and sneezes, hand washing, and keeping unwashed hands away from the face. The use of face masks or coverings has been recommended in public settings to minimise the risk of transmissions. Several vaccines have been developed and many countries have initiated mass vaccination campaigns.

Although work is underway to develop drugs that inhibit the virus, the primary treatment is symptomatic. Management involves the treatment of symptoms, supportive care, isolation, and experimental measures.

During the initial outbreak in Wuhan, China, the virus and disease were commonly referred to as "coronavirus" and "Wuhan coronavirus",[24][25][26] with the disease sometimes called "Wuhan pneumonia".[27][28] In the past, many diseases have been named after geographical locations, such as the Spanish flu,[29] Middle East Respiratory Syndrome, and Zika virus.[30] In January 2020, the WHO recommended 2019-nCov[31] and 2019-nCoV acute respiratory disease[32] as interim names for the virus and disease per 2015 guidance and international guidelines against using geographical locations (e.g. Wuhan, China), animal species, or groups of people in disease and virus names in part to prevent social stigma.[33][34][35] The official names COVID-19 and SARS-CoV-2 were issued by the WHO on 11 February 2020.[36] Tedros Adhanom explained: COfor corona, VIfor virus, Dfor disease and 19 for when the outbreak was first identified (31 December 2019).[37] The WHO additionally uses "the COVID-19 virus" and "the virus responsible for COVID-19" in public communications.[36]

Symptoms of COVID-19 are variable, ranging from mild symptoms to severe illness.[38][39] Common symptoms include headache,[40] loss of smell[41] and taste,[42] nasal congestion and runny nose, cough, muscle pain, sore throat, fever,[43] diarrhea, and breathing difficulties.[44] People with the same infection may have different symptoms, and their symptoms may change over time. Three common clusters of symptoms have been identified: one respiratory symptom cluster with cough, sputum, shortness of breath, and fever; a musculoskeletal symptom cluster with muscle and joint pain, headache, and fatigue; a cluster of digestive symptoms with abdominal pain, vomiting, and diarrhea.[44] In people without prior ear, nose, and throat disorders, loss of taste combined with loss of smell is associated with COVID-19.[45]

Most people (81%) develop mild to moderate symptoms (up to mild pneumonia), while 14% develop severe symptoms (dyspnea, hypoxia, or more than 50% lung involvement on imaging) and 5% of patients suffer critical symptoms (respiratory failure, shock, or multiorgan dysfunction).[46] At least a third of the people who are infected with the virus do not develop noticeable symptoms at any point in time.[47][48][49][50] These asymptomatic carriers tend not to get tested and can spread the disease.[50][51][52][53] Other infected people will develop symptoms later, called "pre-symptomatic", or have very mild symptoms and can also spread the virus.[53]

As is common with infections, there is a delay between the moment a person first becomes infected and the appearance of the first symptoms. The median delay for COVID-19 is four to five days.[54] Most symptomatic people experience symptoms within two to seven days after exposure, and almost all will experience at least one symptom within 12 days.[54][55]

COVID-19 is caused by infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus strain.

The virus is transmitted mainly through the respiratory route after an infected person coughs, sneezes, sings, talks or breathes. A new infection occurs when virus-containing particles exhaled by an infected person, either respiratory droplets or aerosols, get into the mouth, nose, or eyes of other people who are in close contact with the infected person.[57] During human-to-human transmission, an average 1000 infectious SARS-CoV-2 virions are thought to initiate a new infection.

The closer people interact, and the longer they interact, the more likely they are to transmit COVID-19. Closer distances can involve larger droplets (which fall to the ground) and aerosols, whereas longer distances only involve aerosols. Larger droplets can also turn into aerosols (known as droplet nuclei) through evaporation. The relative importance of the larger droplets and the aerosols is not clear as of November 2020; however, the virus is not known to spread between rooms over long distances such as through air ducts. Airborne transmission is able to particularly occur indoors, in high risk locations such as restaurants, choirs, gyms, nightclubs, offices, and religious venues, often when they are crowded or less ventilated. It also occurs in healthcare settings, often when aerosol-generating medical procedures are performed on COVID-19 patients.

Severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) is a novel severe acute respiratory syndrome coronavirus. It was first isolated from three people with pneumonia connected to the cluster of acute respiratory illness cases in Wuhan.[58] All structural features of the novel SARS-CoV-2 virus particle occur in related coronaviruses in nature.[59]

Outside the human body, the virus is destroyed by household soap, which bursts its protective bubble.[60]

SARS-CoV-2 is closely related to the original SARS-CoV.[61] It is thought to have an animal (zoonotic) origin. Genetic analysis has revealed that the coronavirus genetically clusters with the genus Betacoronavirus, in subgenus Sarbecovirus (lineage B) together with two bat-derived strains. It is 96% identical at the whole genome level to other bat coronavirus samples (BatCov RaTG13).[62][63] The structural proteins of SARS-CoV-2 include membrane glycoprotein (M), envelope protein (E), nucleocapsid protein (N), and the spike protein (S). The M protein of SARS-CoV-2 is about 98% similar to the M protein of bat SARS-CoV, maintains around 98% homology with pangolin SARS-CoV, and has 90% homology with the M protein of SARS-CoV; whereas, the similarity is only around 38% with the M protein of MERS-CoV. The structure of the M protein resembles the sugar transporter SemiSWEET.[64]

The many thousands of SARS-CoV-2 variants are grouped into clades.[65] Several different clade nomenclatures have been proposed. Nextstrain divides the variants into five clades (19A, 19B, 20A, 20B, and 20C), while GISAID divides them into seven (L, O, V, S, G, GH, and GR).[66]

Several notable variants of SARS-CoV-2 emerged in late 2020. Cluster 5 emerged among minks and mink farmers in Denmark. After strict quarantines and a mink euthanasia campaign, it is believed to have been eradicated. The Variant of Concern 202012/01 (VOC 202012/01) is believed to have emerged in the United Kingdom in September. The 501Y.V2 Variant, which has the same N501Y mutation, arose independently in South Africa.[67][68]

Three known variants of SARS-CoV-2 are spreading among global populations As of January 2021[update], including the UK Variant (referred to as B.1.1.7) first found in London and Kent, a variant discovered in South Africa (referred to as 1.351), and a variant discovered in Brazil (referred to as P.1).[69]

Using whole genome sequencing, epidemiology and modelling suggest the new UK variant VUI-202012/01 (the first variant under investigation in December 2020) transmits more easily than other strains.[70]

COVID-19 can affect the upper respiratory tract (sinuses, nose, and throat) and the lower respiratory tract (windpipe and lungs).[71] The lungs are the organs most affected by COVID-19 because the virus accesses host cells via the enzyme angiotensin-converting enzyme 2 (ACE2), which is most abundant in type II alveolar cells of the lungs.[72] The virus uses a special surface glycoprotein called a "spike" (peplomer) to connect to ACE2 and enter the host cell.[73] The density of ACE2 in each tissue correlates with the severity of the disease in that tissue and decreasing ACE2 activity might be protective,[74] though another view is that increasing ACE2 using angiotensin II receptor blocker medications could be protective.[75] As the alveolar disease progresses, respiratory failure might develop and death may follow.[76]

Whether SARS-CoV-2 is able to invade the nervous system remains unknown however it is clear that many people with COVID-19 exhibit neurological or mental health issues. The virus is not detected in the CNS of the majority of COVID-19 people with neurological issues. However, SARS-CoV-2 has been detected at low levels in the brains of those who have died from COVID-19, but these results need to be confirmed.[77] Loss of smell results from infection of the support cells of the olfactory epithelium, with subsequent damage to the olfactory neurons.[78] SARS-CoV-2 could cause respiratory failure through affecting the brain stem as other coronaviruses have been found to invade the CNS. While virus has been detected in cerebrospinal fluid of autopsies, the exact mechanism by which it invades the CNS remains unclear and may first involve invasion of peripheral nerves given the low levels of ACE2 in the brain.[79][80][81] The virus may also enter the bloodstream from the lungs and cross the blood-brain barrier to gain access to the CNS, possibly within an infected white blood cell.[77]

The virus also affects gastrointestinal organs as ACE2 is abundantly expressed in the glandular cells of gastric, duodenal and rectal epithelium[82] as well as endothelial cells and enterocytes of the small intestine.[83]

The virus can cause acute myocardial injury and chronic damage to the cardiovascular system.[84] An acute cardiac injury was found in 12% of infected people admitted to the hospital in Wuhan, China,[85] and is more frequent in severe disease.[86] Rates of cardiovascular symptoms are high, owing to the systemic inflammatory response and immune system disorders during disease progression, but acute myocardial injuries may also be related to ACE2 receptors in the heart.[84] ACE2 receptors are highly expressed in the heart and are involved in heart function.[84][87] A high incidence of thrombosis and venous thromboembolism have been found people transferred to Intensive care unit (ICU) with COVID-19 infections, and may be related to poor prognosis.[88] Blood vessel dysfunction and clot formation (as suggested by high D-dimer levels caused by blood clots) are thought to play a significant role in mortality, incidences of clots leading to pulmonary embolisms, and ischaemic events within the brain have been noted as complications leading to death in people infected with SARS-CoV-2. Infection appears to set off a chain of vasoconstrictive responses within the body, constriction of blood vessels within the pulmonary circulation has also been posited as a mechanism in which oxygenation decreases alongside the presentation of viral pneumonia.[89] Furthermore, microvascular blood vessel damage has been reported in a small number of tissue samples of the brains without detected SARS-CoV-2 and the olfactory bulbs from those who have died from COVID-19.[90][91][92]

Another common cause of death is complications related to the kidneys.[89] Early reports show that up to 30% of hospitalized patients both in China and in New York have experienced some injury to their kidneys, including some persons with no previous kidney problems.[93]

Autopsies of people who died of COVID-19 have found diffuse alveolar damage, and lymphocyte-containing inflammatory infiltrates within the lung.[94]

Although SARS-CoV-2 has a tropism for ACE2-expressing epithelial cells of the respiratory tract, people with severe COVID-19 have symptoms of systemic hyperinflammation. Clinical laboratory findings of elevated IL2, IL7, IL6, granulocyte-macrophage colony-stimulating factor (GMCSF), interferon gamma-induced protein10 (IP10), monocyte chemoattractant protein1 (MCP1), macrophage inflammatory protein 1alpha (MIP1alpha), and tumour necrosis factor (TNF) indicative of cytokine release syndrome (CRS) suggest an underlying immunopathology.[85]

Additionally, people with COVID-19 and acute respiratory distress syndrome (ARDS) have classical serum biomarkers of CRS, including elevated C-reactive protein (CRP), lactate dehydrogenase (LDH), D-dimer, and ferritin.[95]

Systemic inflammation results in vasodilation, allowing inflammatory lymphocytic and monocytic infiltration of the lung and the heart. In particular, pathogenic GM-CSF-secreting Tcells were shown to correlate with the recruitment of inflammatory IL-6-secreting monocytes and severe lung pathology in people with COVID-19.[96] Lymphocytic infiltrates have also been reported at autopsy.[94]

Multiple viral and host factors affect the pathogenesis of the virus. The S-protein, otherwise known as the spike protein, is the viral component that attaches to the host receptor via the ACE2 receptors. It includes two subunits: S1 and S2. S1 determines the virus host range and cellular tropism via the receptor binding domain. S2 mediates the membrane fusion of the virus to its potential cell host via the H1 and HR2, which are heptad repeat regions. Studies have shown that S1 domain induced IgG and IgA antibody levels at a much higher capacity. It is the focus spike proteins expression that are involved in many effective COVID-19 vaccines.[97]

The M protein is the viral protein responsible for the transmembrane transport of nutrients. It is the cause of the bud release and the formation of the viral envelope.[98] The N and E protein are accessory proteins that interfere with the host's immune response.[98]

Human angiotensin converting enzyme 2 (hACE2) is the host factor that SARS-COV2 virus targets causing COVID-19. Theoretically the usage of angiotensin receptor blockers (ARB) and ACE inhibitors upregulating ACE2 expression might increase morbidity with COVID-19, though animal data suggest some potential protective effect of ARB. However no clinical studies have proven susceptibility or outcomes. Until further data is available, guidelines and recommendations for hypertensive patients remain.[99]

The virus' effect on ACE2 cell surfaces leads to leukocytic infiltration, increased blood vessel permeability, alveolar wall permeability, as well as decreased secretion of lung surfactants. These effects cause the majority of the respiratory symptoms. However, the aggravation of local inflammation causes a cytokine storm eventually leading to a systemic inflammatory response syndrome.[100]

The severity of the inflammation can be attributed to the severity of what is known as the cytokine storm.[101] Levels of interleukin1B, interferon-gamma, interferon-inducible protein 10, and monocyte chemoattractant protein1 were all associated with COVID-19 disease severity. Treatment has been proposed to combat the cytokine storm as it remains to be one of the leading causes of morbidity and mortality in COVID-19 disease.[102]

A cytokine storm is due to an acute hyperinflammatory response that is responsible for clinical illness in an array of diseases but in COVID-19, it is related to worse prognosis and increased fatality. The storm causes the acute respiratory distress syndrome, blood clotting events such as strokes, myocardial infarction, encephalitis, acute kidney injury, and vasculitis. The production of IL-1, IL-2, IL-6, TNF-alpha, and interferon-gamma, all crucial components of normal immune responses, inadvertently become the causes of a cytokine storm. The cells of the central nervous system, the microglia, neurons, and astrocytes, are also involved in the release of pro-inflammatory cytokines affecting the nervous system, and effects of cytokine storms toward the CNS are not uncommon.[103]

Pregnancy response

Nowadays, there are many unknowns for pregnant women during the COVID-19 pandemic. Given that they are prone to suffering from complications and severe disease infection with other types of coronaviruses, they have been identified as a vulnerable group and advised to take supplementary preventive measures.[104]

Physiological responses to pregnancy can include:

However, from the current evidence base, it is difficult to draw final conclusions on whether pregnant women are at increased risk of grave consequences of this virus.[104]

In addition to the above, other clinical studies have proved that SARS-CoV-2 can affect the period of pregnancy in different ways. On the one hand, there is little evidence of its impact up to 12 weeks gestation. On the other hand, COVID-19 infection may cause increased rates of unfavorable outcomes in the course of the pregnancy. Some examples of these could be fetal growth restriction, preterm birth, and perinatal mortality, which refers to the fetal death past 22 or 28 completed weeks of pregnancy as well as the death among live-born children up to seven completed days of life.[104]

COVID-19 can provisionally be diagnosed on the basis of symptoms and confirmed using reverse transcription polymerase chain reaction (RT-PCR) or other nucleic acid testing of infected secretions.[105][106] Along with laboratory testing, chest CT scans may be helpful to diagnose COVID-19 in individuals with a high clinical suspicion of infection.[107] Detection of a past infection is possible with serological tests, which detect antibodies produced by the body in response to the infection.[105]

The standard methods of testing for presence of SARS-CoV-2 are nucleic acid tests,[105][108] which detects the presence of viral RNA fragments.[109] As these tests detect RNA but not infectious virus, its "ability to determine duration of infectivity of patients is limited."[110] The test is typically done on respiratory samples obtained by a nasopharyngeal swab; however, a nasal swab or sputum sample may also be used.[111][112] Results are generally available within hours.[105] The WHO has published several testing protocols for the disease.[113]

A number of laboratories and companies have developed serological tests, which detect antibodies produced by the body in response to infection. Several have been evaluated by Public Health England and approved for use in the UK.[114]

The University of Oxford's CEBM has pointed to mounting evidence[115][116] that "a good proportion of 'new' mild cases and people re-testing positives after quarantine or discharge from hospital are not infectious, but are simply clearing harmless virus particles which their immune system has efficiently dealt with" and have called for "an international effort to standardize and periodically calibrate testing"[117] On 7September, the UK government issued "guidance for procedures to be implemented in laboratories to provide assurance of positive SARS-CoV-2 RNA results during periods of low prevalence, when there is a reduction in the predictive value of positive test results".[118]

Chest CT scans may be helpful to diagnose COVID-19 in individuals with a high clinical suspicion of infection but are not recommended for routine screening.[107][119] Bilateral multilobar ground-glass opacities with a peripheral, asymmetric, and posterior distribution are common in early infection.[107][120] Subpleural dominance, crazy paving (lobular septal thickening with variable alveolar filling), and consolidation may appear as the disease progresses.[107][121] Characteristic imaging features on chest radiographs and computed tomography (CT) of people who are symptomatic include asymmetric peripheral ground-glass opacities without pleural effusions.[122]

Many groups have created COVID-19 datasets that include imagery such as the Italian Radiological Society which has compiled an international online database of imaging findings for confirmed cases.[123] Due to overlap with other infections such as adenovirus, imaging without confirmation by rRT-PCR is of limited specificity in identifying COVID-19.[122] A large study in China compared chest CT results to PCR and demonstrated that though imaging is less specific for the infection, it is faster and more sensitive.[106]

In late 2019, the WHO assigned emergency ICD-10 disease codes U07.1 for deaths from lab-confirmed SARS-CoV-2 infection and U07.2 for deaths from clinically or epidemiologically diagnosed COVID-19 without lab-confirmed SARS-CoV-2 infection.[124]

The main pathological findings at autopsy are:

Preventive measures to reduce the chances of infection include staying at home, wearing a mask in public, avoiding crowded places, keeping distance from others, ventilating indoor spaces, managing potential exposure durations,[129] washing hands with soap and water often and for at least twenty seconds, practising good respiratory hygiene, and avoiding touching the eyes, nose, or mouth with unwashed hands.[130][131] Poor hygienic conditions in underdeveloped countries such as the Dominican Republic, where there is also a gender, class, and ethnic gap, complicate the whole process of COVID-19 prevention.[132]

Those diagnosed with COVID-19 or who believe they may be infected are advised by the CDC to stay home except to get medical care, call ahead before visiting a healthcare provider, wear a face mask before entering the healthcare provider's office and when in any room or vehicle with another person, cover coughs and sneezes with a tissue, regularly wash hands with soap and water and avoid sharing personal household items.[133][134]

The first COVID-19 vaccine was granted regulatory approval on 2December by the UK medicines regulator MHRA.[135] It was evaluated for emergency use authorization (EUA) status by the US FDA, and in several other countries.[136] Initially, the US National Institutes of Health guidelines do not recommend any medication for prevention of COVID-19, before or after exposure to the SARS-CoV-2 virus, outside the setting of a clinical trial.[137][138] Without a vaccine, other prophylactic measures, or effective treatments, a key part of managing COVID-19 is trying to decrease and delay the epidemic peak, known as "flattening the curve".[139] This is done by slowing the infection rate to decrease the risk of health services being overwhelmed, allowing for better treatment of current cases, and delaying additional cases until effective treatments or a vaccine become available.[139][140]

A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARSCoV2), the virus causing coronavirus disease 2019 (COVID19). Prior to the COVID19 pandemic, there was an established body of knowledge about the structure and function of coronaviruses causing diseases like severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), which enabled accelerated development of various vaccine technologies during early 2020.[141] On 10 January 2020, the SARS-CoV-2 genetic sequence data was shared through GISAID, and by 19 March, the global pharmaceutical industry announced a major commitment to address COVID-19.[142]

In Phase III trials, several COVID19 vaccines have demonstrated efficacy as high as 95% in preventing symptomatic COVID19 infections. As of April2021[update], 13 vaccines are authorized by at least one national regulatory authority for public use: two RNA vaccines (the PfizerBioNTech vaccine and the Moderna vaccine), five conventional inactivated vaccines (BBIBP-CorV, CoronaVac, Covaxin, WIBP-CorV and CoviVac), four viral vector vaccines (Sputnik V, the OxfordAstraZeneca vaccine, Convidecia, and the Johnson & Johnson vaccine), and two protein subunit vaccines (EpiVacCorona and RBD-Dimer).[143] In total, as of March2021[update], 308 vaccine candidates are in various stages of development, with 73 in clinical research, including 24 in Phase I trials, 33 in Phase III trials, and 16 in Phase III development.[143]

Many countries have implemented phased distribution plans that prioritize those at highest risk of complications, such as the elderly, and those at high risk of exposure and transmission, such as healthcare workers.[144] Stanley Plotkin and Neal Halsey wrote an article published by Oxford Clinical Infectious Diseases that urged single dose interim use in order to extend vaccination to as many people as possible until vaccine availability improved.[145] Several other articles and media provided evidence for delaying second doses in the same line of reasoning.[146][147][148]

Social distancing (also known as physical distancing) includes infection control actions intended to slow the spread of the disease by minimising close contact between individuals. Methods include quarantines; travel restrictions; and the closing of schools, workplaces, stadiums, theatres, or shopping centres. Individuals may apply social distancing methods by staying at home, limiting travel, avoiding crowded areas, using no-contact greetings, and physically distancing themselves from others.[4] Many governments are now mandating or recommending social distancing in regions affected by the outbreak.[155]

Outbreaks have occurred in prisons due to crowding and an inability to enforce adequate social distancing.[156][157] In the United States, the prisoner population is aging and many of them are at high risk for poor outcomes from COVID-19 due to high rates of coexisting heart and lung disease, and poor access to high-quality healthcare.[156]

Self-isolation at home has been recommended for those diagnosed with COVID-19 and those who suspect they have been infected. Health agencies have issued detailed instructions for proper self-isolation.[158] Many governments have mandated or recommended self-quarantine for entire populations. The strongest self-quarantine instructions have been issued to those in high-risk groups.[159] Those who may have been exposed to someone with COVID-19 and those who have recently travelled to a country or region with the widespread transmission have been advised to self-quarantine for 14 days from the time of last possible exposure.[citation needed]

The WHO and the US CDC recommend individuals wear non-medical face coverings in public settings where there is an increased risk of transmission and where social distancing measures are difficult to maintain.[160][161] This recommendation is meant to reduce the spread of the disease by asymptomatic and pre-symptomatic individuals and is complementary to established preventive measures such as social distancing.[161][162] Face coverings limit the volume and travel distance of expiratory droplets dispersed when talking, breathing, and coughing.[161][162] A face covering without vents or holes will also filter out particles containing the virus from inhaled and exhaled air, reducing the chances of infection.[163] But, if the mask include an exhalation valve, a wearer that is infected (maybe without having noticed that, and asymptomatic) would transmit the virus outwards through it, despite any certification they can have. So the masks with exhalation valve are not for the infected wearers, and are not reliable to stop the pandemic in a large scale. Many countries and local jurisdictions encourage or mandate the use of face masks or cloth face coverings by members of the public to limit the spread of the virus.[164]

Masks are also strongly recommended for those who may have been infected and those taking care of someone who may have the disease.[165] When not wearing a mask, the CDC recommends covering the mouth and nose with a tissue when coughing or sneezing and recommends using the inside of the elbow if no tissue is available. Proper hand hygiene after any cough or sneeze is encouraged. Healthcare professionals interacting directly with people who have COVID-19 are advised to use respirators at least as protective as NIOSH-certified N95 or equivalent, in addition to other personal protective equipment.[166]

The WHO recommends ventilation and air filtration in public spaces to help clear out infectious aerosols.[167][168][169]

The Harvard T.H. Chan School of Public Health recommends a healthy diet, being physically active, managing psychological stress, and getting enough sleep.[170]

There is no good evidence that vitamin D status has any relationship with COVID-19 health outcomes.[171]

Thorough hand hygiene after any cough or sneeze is required.[172] The WHO also recommends that individuals wash hands often with soap and water for at least twenty seconds, especially after going to the toilet or when hands are visibly dirty, before eating and after blowing one's nose.[173] However, despite the measures recommended by the WHO, not all households have access to some basic necessities. In the Dominican Republic, 46% of households do not have access to safe drinking water. Only 44.9% receive drinking water at home every two to three days[132]. When soap and water are not available, the CDC recommends using an alcohol-based hand sanitiser with at least 60% alcohol.[174] For areas where commercial hand sanitisers are not readily available, the WHO provides two formulations for local production. In these formulations, the antimicrobial activity arises from ethanol or isopropanol. Hydrogen peroxide is used to help eliminate bacterial spores in the alcohol; it is "not an active substance for hand antisepsis." Glycerol is added as a humectant.[175]

After being expelled from the body, coronaviruses can survive on surfaces for hours to days. If a person touches the dirty surface, they may deposit the virus at the eyes, nose, or mouth where it can enter the body and cause infection.[18] Current evidence indicates that contact with infected surfaces is not the main driver of COVID-19,[176][177][178] leading to recommendations for optimised disinfection procedures to avoid issues such as the increase of antimicrobial resistance through the use of inappropriate cleaning products and processes.[179][180] Deep cleaning and other surface sanitation has been criticized as hygiene theater, giving a false sense of security against something primarily spread through the air.[181][182]

The amount of time that the virus can survive depends significantly on the type of surface, the temperature, and the humidity.[183] Coronaviruses die very quickly when exposed to the UV light in sunlight.[183] Like other enveloped viruses, SARS-CoV-2 survives longest when the temperature is at room temperature or lower, and when the relative humidity is low (<50%).[183]

On many surfaces, including as glass, some types of plastic, stainless steel, and skin, the virus can remain infective for several days indoors at room temperature, or even about a week under ideal conditions.[183] On some surfaces, including cotton fabric and copper, the virus usually dies after a few hours.[183] As a rule of thumb, the virus dies faster on porous surfaces than on non-porous surfaces.[183] However, this rule is not absolute, and of the many surfaces tested, two with the longest survival times are N95 respirator masks and surgical masks, both of which are considered porous surfaces.[183]

The CDC says that in most situations, cleaning surfaces with soap or detergant, not disinfecting, is enough to reduce risk of transmission.[184][185] The CDC recommends that if a COVID-19 case is suspected or confirmed at a facility such as an office or day care, all areas such as offices, bathrooms, common areas, shared electronic equipment like tablets, touch screens, keyboards, remote controls, and ATM machines used by the ill persons should be disinfected.[186] Surfaces may be decontaminated with 6271 percent ethanol, 50100 percent isopropanol, 0.1 percent sodium hypochlorite, 0.5 percent hydrogen peroxide, and 0.27.5 percent povidone-iodine. Other solutions, such as benzalkonium chloride and chlorhexidine gluconate, are less effective. Ultraviolet germicidal irradiation may also be used.[167] A datasheet comprising the authorised substances to disinfection in the food industry (including suspension or surface tested, kind of surface, use dilution, disinfectant and inocuylum volumes) can be seen in the supplementary material of.[179]

There is no specific, effective treatment or cure for coronavirus disease 2019 (COVID-19), the disease caused by the SARS-CoV-2 virus.[187][needs update][188] Thus, the cornerstone of management of COVID-19 is supportive care, which includes treatment to relieve symptoms, fluid therapy, oxygen support and prone positioning as needed, and medications or devices to support other affected vital organs.[189][190][191]

Most cases of COVID-19 are mild. In these, supportive care includes medication such as paracetamol or NSAIDs to relieve symptoms (fever, body aches, cough), proper intake of fluids, rest, and nasal breathing.[192][188][193][194] Good personal hygiene and a healthy diet are also recommended.[195] The U.S. Centers for Disease Control and Prevention (CDC) recommend that those who suspect they are carrying the virus isolate themselves at home and wear a face mask.[196]

People with more severe cases may need treatment in hospital. In those with low oxygen levels, use of the glucocorticoid dexamethasone is strongly recommended, as it can reduce the risk of death.[197][198][199] Noninvasive ventilation and, ultimately, admission to an intensive care unit for mechanical ventilation may be required to support breathing.[200] Extracorporeal membrane oxygenation (ECMO) has been used to address the issue of respiratory failure, but its benefits are still under consideration.[201][202]

The severity of COVID-19 varies. The disease may take a mild course with few or no symptoms, resembling other common upper respiratory diseases such as the common cold. In 34% of cases (7.4% for those over age 65) symptoms are severe enough to cause hospitalization.[207] Mild cases typically recover within two weeks, while those with severe or critical diseases may take three to six weeks to recover. Among those who have died, the time from symptom onset to death has ranged from two to eight weeks.[62] The Italian Istituto Superiore di Sanit reported that the median time between the onset of symptoms and death was twelve days, with seven being hospitalised. However, people transferred to an ICU had a median time of ten days between hospitalisation and death.[208] Prolonged prothrombin time and elevated C-reactive protein levels on admission to the hospital are associated with severe course of COVID-19 and with a transfer to ICU.[209][210]

Some early studies suggest 10% to 20% of people with COVID-19 will experience symptoms lasting longer than a month.[211][212] A majority of those who were admitted to hospital with severe disease report long-term problems including fatigue and shortness of breath.[213] On 30 October 2020 WHO chief Tedros Adhanom warned that "to a significant number of people, the COVID virus poses a range of serious long-term effects." He has described the vast spectrum of COVID-19 symptoms that fluctuate over time as "really concerning". They range from fatigue, a cough and shortness of breath, to inflammation and injury of major organs including the lungs and heart, and also neurological and psychologic effects. Symptoms often overlap and can affect any system in the body. Infected people have reported cyclical bouts of fatigue, headaches, months of complete exhaustion, mood swings, and other symptoms. Tedros has concluded that therefore herd immunity is "morally unconscionable and unfeasible".[214]

In terms of hospital readmissions about 9% of 106,000 individuals had to return for hospital treatment within two months of discharge. The average to readmit was eight days since first hospital visit. There are several risk factors that have been identified as being a cause of multiple admissions to a hospital facility. Among these are advanced age (above 65 years of age) and presence of a chronic condition such as diabetes, COPD, heart failure or chronic kidney disease.[215][216]

According to scientific reviews smokers are more likely to require intensive care or die compared to non-smokers,[217][218] air pollution is similarly associated with risk factors,[218] and pre-existing heart and lung diseases[219] and also obesity contributes to an increased health risk of COVID-19.[218][220][221]

It is also assumed that those that are immunocompromised are at higher risk of getting severely sick from SARS-CoV-2.[222] One research that looked into the COVID-19 infections in hospitalized kidney transplant recipients found a mortality rate of 11%.[223]

Genetics also plays an important role in the ability to fight off the disease. For instance, those that do not produce detectable type I interferons or produce auto-antibodies against these may get much sicker from COVID-19.[224][225] Genetic screening is able to detect interferon effector genes.[226]

Pregnant women may be at higher risk of severe COVID-19 infection based on data from other similar viruses, like SARS and MERS, but data for COVID-19 is lacking.

While very young children have experienced lower rates of infection, older children have a rate of infection that is similar to the population as a whole.[227][228] Children are likely to have milder symptoms and are at lower risk of severe disease than adults. The CDC reports that in the US roughly a third of hospitalized children were admitted to the ICU,[229] while a European multinational study of hospitalized children from June 2020 found that about 8% of children admitted to a hospital needed intensive care.[230] Four of the 582 children (0.7%) in the European study died, but the actual mortality rate could be "substantially lower" since milder cases that did not seek medical help were not included in the study.[231][232]

Complications may include pneumonia, acute respiratory distress syndrome (ARDS), multi-organ failure, septic shock, and death.[233][234][235][236] Cardiovascular complications may include heart failure, arrhythmias, heart inflammation, and blood clots.[237][238][239][240] Approximately 2030% of people who present with COVID-19 have elevated liver enzymes, reflecting liver injury.[241][138]

Neurologic manifestations include seizure, stroke, encephalitis, and GuillainBarr syndrome (which includes loss of motor functions).[242][243] Following the infection, children may develop paediatric multisystem inflammatory syndrome, which has symptoms similar to Kawasaki disease, which can be fatal.[244][245] In very rare cases, acute encephalopathy can occur, and it can be considered in those who have been diagnosed with COVID-19 and have an altered mental status.[246]

In the case of pregnant women, it is important to note that, according to the Centers for Disease Control and Prevention, pregnant women are at increased risk of becoming seriously ill from COVID-19. [247] This is because pregnant women with COVID-19 appear to be more likely to develop respiratory and obstetric complications that can lead to miscarriage, premature delivery and intrauterine growth restriction. [247]

Some early studies suggest that that ten to twenty percent of people with COVID-19 will experience symptoms lasting longer than a month.[248][249] A majority of those who were admitted to hospital with severe disease report long-term problems, including fatigue and shortness of breath.[250] About 5-10% of patients admitted to hospital progress to severe or critical disease, including pneumonia and acute respiratory failure.[251]

By a variety of mechanisms, the lungs are the organs most affected in COVID-19.[252] The majority of CT scans performed show lung abnormalities in people tested after 28 days of illness.[253]

People with advanced age, severe disease, prolonged ICU stays, or who smoke are more likely to have long lasting effects, including pulmonary fibrosis.[254] Overall, approximately one third of those investigated after four weeks will have findings of pulmonary fibrosis or reduced lung function as measured by DLCO, even in people who are asymptomatic, but with the suggestion of continuing improvement with the passing of more time.[252]

The immune response by humans to CoV-2 virus occurs as a combination of the cell-mediated immunity and antibody production,[255] just as with most other infections.[256] Since SARS-CoV-2 has been in the human population only since December 2019, it remains unknown if the immunity is long-lasting in people who recover from the disease.[257] The presence of neutralizing antibodies in blood strongly correlates with protection from infection, but the level of neutralizing antibody declines with time. Those with asymptomatic or mild disease had undetectable levels of neutralizing antibody two months after infection. In another study, the level of neutralizing antibody fell four-fold one to four months after onset of symptoms. However, the lack of antibody in the blood does not mean antibody will not be rapidly produced upon reexposure to SARS-CoV-2. Memory B cells specific for the spike and nucleocapsid proteins of SARS-CoV-2 last for at least six months after appearance of symptoms.[257] Nevertheless, 15 cases of reinfection with SARS-CoV-2 have been reported using stringent CDC criteria requiring identification of a different variant from the second infection. There are likely to be many more people who have been reinfected with the virus. Herd immunity will not eliminate the virus if reinfection is common.[257] Some other coronaviruses circulating in people are capable of reinfection after roughly a year.[258] Nonetheless, on 3March 2021, scientists reported that a much more contagious COVID-19 variant, Lineage P.1, first detected in Japan, and subsequently found in Brazil, as well as in several places in the United States, may be associated with COVID-19 disease reinfection after recovery from an earlier COVID-19 infection.[259][260]

Several measures are commonly used to quantify mortality.[261] These numbers vary by region and over time and are influenced by the volume of testing, healthcare system quality, treatment options, time since the initial outbreak, and population characteristics such as age, sex, and overall health.[262] Data has changed throughout the course of the pandemic, as much within as between countries. However, what has remained constant is the prevalence of women affected by Covid in contrast to men, although the fatalities have not been as high as theirs. This was especially so at the beginning of the pandemic. This might be due to the fact that both professional and home care affairs have been an area relegated to women in history. These are obviously closer to the virus than other areas of work.[263] Regarding age and sex, in India, for instance, COVID-19 cases between men and women did not represent a uniform ratio among different age groups. Mortality rates were higher in women, especially in the 40-49 year age group. The socioeconomic status can also affect the number of people affected by COVID-19. We do not own precise data about this factor, but in other national contexts it has been found that marginalised groups are at higher risk of infection and death.[264] The mortality rate reflects the number of deaths within a specific demographic group divided by the population of that demographic group. Consequently, the mortality rate reflects the prevalence as well as the severity of the disease within a given population. Mortality rates are highly correlated to age, with relatively low rates for young people and relatively high rates among the elderly.[265][266][267] In fact, one relevant factor of mortality rates is the age structure of the countries populations. For example, the case fatality rate for COVID-19 is lower in India than in the US since Indias younger population represents a larger percentage than in the US.[264]

The case fatality rate (CFR) reflects the number of deaths divided by the number of diagnosed cases within a given time interval. Based on Johns Hopkins University statistics, the global death-to-case ratio is 2.1% (3,099,838/146,479,113) as of 25 April 2021.[6] The number varies by region.[268][269] The CFR may not reflect the true severity of the disease, because some infected individuals remain asymptomatic or experience only mild symptoms, and hence such infections may not be included in official case reports. Moreover, the CFR may vary markedly over time and across locations due to the availability of live virus tests.

Total confirmed cases over time

Total confirmed cases of COVID-19 per million people[270]

Total confirmed deaths due to COVID-19 per million people[271]

A key metric in gauging the severity of COVID-19 is the infection fatality rate (IFR), also referred to as the infection fatality ratio or infection fatality risk.[272][273][274] This metric is calculated by dividing the total number of deaths from the disease by the total number of infected individuals; hence, in contrast to the CFR, the IFR incorporates asymptomatic and undiagnosed infections as well as reported cases.[275]

A December 2020 systematic review and meta-analysis estimated that population IFR during the first wave of the pandemic was about 0.5% to 1% in many locations (including France, Netherlands, New Zealand, and Portugal), 1% to 2% in other locations (Australia, England, Lithuania, and Spain), and exceeded 2% in Italy.[276] That study also found that most of these differences in IFR reflected corresponding differences in the age composition of the population and age-specific infection rates; in particular, the metaregression estimate of IFR is very low for children and younger adults (e.g., 0.002% at age 10 and 0.01% at age 25) but increases progressively to 0.4% at age 55, 1.4% at age 65, 4.6% at age 75, and 15% at age 85.[276] These results were also highlighted in a December 2020 report issued by the WHO.[277]

At an early stage of the pandemic, the World Health Organization reported estimates of IFR between 0.3% and 1%.[278][279] On 2July, The WHO's chief scientist reported that the average IFR estimate presented at a two-day WHO expert forum was about 0.6%.[280][281] In August, the WHO found that studies incorporating data from broad serology testing in Europe showed IFR estimates converging at approximately 0.51%.[282] Firm lower limits of IFRs have been established in a number of locations such as New York City and Bergamo in Italy since the IFR cannot be less than the population fatality rate. As of 10 July, in New York City, with a population of 8.4 million, 23,377 individuals (18,758 confirmed and 4,619 probable) have died with COVID-19 (0.3% of the population).[283] Antibody testing in New York City suggested an IFR of ~0.9%,[284] and ~1.4%.[285] In Bergamo province, 0.6% of the population has died.[286] In September 2020 the U.S. Center for Disease Control & Prevention reported preliminary estimates of age-specific IFRs for public health planning purposes.[287]

Early reviews of epidemiologic data showed gendered impact of the pandemic and a higher mortality rate in men in China and Italy.[289][290][291] According to global data, COVID-19 case fatality rates are higher among men than women in most countries. However, in a few countries like India, Nepal, Vietnam, and Slovenia the fatality cases are higher in women than men.[264] This might be due to the fact that both professional and home care affairs have been an area relegated to women in history. These are obviously closer to the virus than other areas of work. For example, in Spain since the sanitary crisis began, healthcare workers have been more affected than anyone else. Almost 50,000 of them have been affected, of whom a 66% are women.[263]

The Chinese Center for Disease Control and Prevention reported the death rate was 2.8% for men and 1.7% for women.[292] Later reviews in June 2020 indicated that there is no significant difference in susceptibility or in CFR between genders.[293][294] One review acknowledges the different mortality rates in Chinese men, suggesting that it may be attributable to lifestyle choices such as smoking and drinking alcohol rather than genetic factors.[295] Smoking, which in some countries like China is mainly a male activity, is a habit that contributes to increasing significantly the case fatality rates among men.[264] Sex-based immunological differences, lesser prevalence of smoking in women and men developing co-morbid conditions such as hypertension at a younger age than women could have contributed to the higher mortality in men.[296] In Europe, 57% of the infected people were men and 72% of those died with COVID-19 were men.[297] The fact that women boast a longer life expectancy than men also makes a bigger group of female population at risk of contracting the disease. Not only that, it also creates an ageist dynamic that can end up in discrimination for being both a woman and old.[263] As of April 2020, the US government is not tracking sex-related data of COVID-19 infections.[298] Research has shown that viral illnesses like Ebola, HIV, influenza and SARS affect men and women differently.[298] The WHO issued a report in 2007 that showed that more than half the SARS cases at the beginning of 2000 were women.[263]

Regarding the spread of information about COVID-19, many researchers and experts agreed that data on COVID-19 infection should be sex-disaggregated. This would allow to develop solutions to the pandemic from a gender-equitable perspective, given sex-differences in fatality rates. Also, this would allow experts to deliver high-quality data separately to men and women.[264]

In the US, a greater proportion of deaths due to COVID-19 have occurred among African Americans and other minority groups.[299] Structural factors that prevent them from practicing social distancing include their concentration in crowded substandard housing and in "essential" occupations such as retail grocery workers, public transit employees, health-care workers and custodial staff. Greater prevalence of lacking health insurance and care and of underlying conditions such as diabetes, hypertension and heart disease also increase their risk of death.[300] Similar issues affect Native American and Latino communities.[299] On the one hand, in the Dominican Republic there is a clear example of both gender and ethnic inequality. In this Latin American territory, there is great inequality and precariousness that especially affects Dominican women, with greater emphasis on those of Haitian descent.[132] According to a US health policy non-profit, 34% of American Indian and Alaska Native People (AIAN) non-elderly adults are at risk of serious illness compared to 21% of white non-elderly adults.[301] The source attributes it to disproportionately high rates of many health conditions that may put them at higher risk as well as living conditions like lack of access to clean water.[302] Leaders have called for efforts to research and address the disparities.[303] In the U.K., a greater proportion of deaths due to COVID-19 have occurred in those of a Black, Asian, and other ethnic minority background.[304][305][306] More severe impacts upon victims including the relative incidence of the necessity of hospitalization requirements, and vulnerability to the disease has been associated via DNA analysis to be expressed in genetic variants at chromosomal region 3, features that are associated with European Neanderthal heritage. That structure imposes greater risks that those affected will develop a more severe form of the disease.[307] The findings are from Professor Svante Pbo and researchers he leads at the Max Planck Institute for Evolutionary Anthropology and the Karolinska Institutet.[307] This admixture of modern human and Neanderthal genes is estimated to have occurred roughly between 50,000 and 60,000 years ago in Southern Europe.[307]

Biological factors (immune response) and the general behaviour (habits) can strongly determine the consequences of COVID-19.[264] Most of those who die of COVID-19 have pre-existing (underlying) conditions, including hypertension, diabetes mellitus, and cardiovascular disease.[308] According to March data from the United States, 89% of those hospitalised had preexisting conditions.[309] The Italian Istituto Superiore di Sanit reported that out of 8.8% of deaths where medical charts were available, 96.1% of people had at least one comorbidity with the average person having 3.4 diseases.[208] According to this report the most common comorbidities are hypertension (66% of deaths), type2 diabetes (29.8% of deaths), Ischemic Heart Disease (27.6% of deaths), atrial fibrillation (23.1% of deaths) and chronic renal failure (20.2% of deaths).

Most critical respiratory comorbidities according to the CDC, are: moderate or severe asthma, pre-existing COPD, pulmonary fibrosis, cystic fibrosis.[310] Evidence stemming from meta-analysis of several smaller research papers also suggests that smoking can be associated with worse outcomes.[311][312] When someone with existing respiratory problems is infected with COVID-19, they might be at greater risk for severe symptoms.[313] COVID-19 also poses a greater risk to people who misuse opioids and methamphetamines, insofar as their drug use may have caused lung damage.[314]

In August 2020 the CDC issued a caution that tuberculosis (TB) infections could increase the risk of severe illness or death. The WHO recommended that people with respiratory symptoms be screened for both diseases, as testing positive for COVID-19 could not rule out co-infections. Some projections have estimated that reduced TB detection due to the pandemic could result in 6.3 million additional TB cases and 1.4 million TB-related deaths by 2025.[315]

Link:

COVID-19 - Wikipedia

SOURCES:

UpToDate: Coronavirus disease 2019 (COVID-19): Epidemiology, virology, clinical features, diagnosis and prevention.

Medscape: Kidney Complications in COVID-19 Send Hospitals Scrambling.

Global Radiology CME: COVID-19 Presenting with Syncope.

Iranian Red Crescent Medical Journal: Frequent Convulsive Seizures in an Adult Patient With COVID-19: A Case Report.

Consul General of the Official Colleges of Podiatrists, Spain: COVID-19 Compatible Case Register.

World Health Organization: Q&A on coronaviruses (COVID-19), Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19).

CDC: Coronavirus disease 2019 (COVID-19) and you, Symptoms of coronavirus disease 2019, Symptoms,Coronavirus Disease 2019 (COVID-19).

University of Alabama at Birmingham: Sorting out symptoms of COVID-19, influenza, colds and allergies.

UpToDate: Coronavirus disease 2019 (COVID-19).

Merck Manual Consumer Version: Fever in Adults, Shortness of Breath.

Loma Linda University Health: Coronavirus 2019 (COVID-19).

American Society of Clinical Oncology: Shortness of Breath or Dyspnea.

American Academy of Family Physicians: Shortness of Breath.

American Academy of Ophthalmology: Coronavirus Eye Safety.

The Lancet Gastroenterology and Hepatology: Liver injury in COVID-19: management and challenges.

National Institute of Allergy and Infectious Diseases Cold, Flu, or Allergy?

The New England Journal of Medicine: Large-Vessel Stroke as Presenting Feature of Covid-19 in the Young.

American Stroke Association: Stroke Symptoms."

Boston Childrens Hospital: COVID-19 and a serious inflammatory syndrome in children: Unpacking recent warnings.

Nemours/KidsHealth: Kawasaki Disease, Fevers.

Morbidity and Mortality Weekly Report: Coronavirus Disease 2019 in Children United States, February 12-April 2, 2020.

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Signs of Coronavirus (COVID-19) - WebMD

The West Virginia Department of Health and Human Resources (DHHR) reports as of April 25, 2021, there have been 2,673,838 total confirmatory laboratory results received for COVID-19, with 151,382 total cases and 2,821 total deaths.DHHR has confirmed the deaths of a 63-year old male from Raleigh County, a 43-year old male from Raleigh County, a 73-year old female from Raleigh County and a 78-year old female from Kanawha County.We remember today the unique burden the pandemic has placed upon children who have suffered loss of a family member, said Bill J. Crouch, DHHR Cabinet Secretary. We must do all we can to support them and keep them safe.CASES PER COUNTY: Barbour (1,368), Berkeley (11,877), Boone (1,928), Braxton (885), Brooke (2,138), Cabell (8,677), Calhoun (276), Clay (467), Doddridge (560), Fayette (3,328), Gilmer (745), Grant (1,248), Greenbrier (2,691), Hampshire (1,742), Hancock (2,732), Hardy (1,461), Harrison (5,506), Jackson (1,951), Jefferson (4,445), Kanawha (14,390), Lewis (1,146), Lincoln (1,421), Logan (2,994), Marion (4,244), Marshall (3,322), Mason (1,946), McDowell (1,525), Mercer (4,625), Mineral (2,797), Mingo (2,457), Monongalia (9,027), Monroe (1,094), Morgan (1,105), Nicholas (1,547), Ohio (4,097), Pendleton (695), Pleasants (848), Pocahontas (657), Preston (2,832), Putnam (4,896), Raleigh (6,390), Randolph (2,508), Ritchie (673), Roane (591), Summers (774), Taylor (1,206), Tucker (524), Tyler (677), Upshur (1,833), Wayne (2,851), Webster (459), Wetzel (1,247), Wirt (384), Wood (7,626), Wyoming (1,949).

Delays may be experienced with the reporting of information from the local health department to DHHR. As case surveillance continues at the local health department level, it may reveal that those tested in a certain county may not be a resident of that county, or even the state as an individual in question may have crossed the state border to be tested.

West Virginians may pre-register for their COVID-19 vaccination at vaccinate.wv.gov. The COVID-19 dashboard located at http://www.coronavirus.wv.gov shows the total number of vaccines administered. Please see the vaccine summary tab for more detailed information.

Free pop-up COVID-19 testing is available today in Greenbrier County and on Monday, April 26 in Barbour, Berkeley, Jefferson, Lincoln, Logan, Marshall, Mineral, Monongalia, Morgan, Pendleton, Preston and Wayne counties:

Greenbrier County

10:00 AM 5:00 PM, Dorie Miller Park, 396 Feamster Road, Lewisburg, WV

April 26

Barbour County

9:00 AM 11:00 AM, Barbour County Health Department, 109 Wabash Avenue, Philippi, WV

1:00 PM 5:00 PM, Junior Volunteer Fire Department, 331 Row Avenue, Junior, WV

Berkeley County

10:00 AM 5:00 PM, 891 Auto Parts Place, Martinsburg, WV

10:00 AM 5:00 PM, Ambrose Park, 25404 Mall Drive, Martinsburg, WV

Jefferson County

10:00 AM 6:00 PM, Hollywood Casino, 750 Hollywood Drive, Charles Town, WV

12:00 PM 5:00 PM, Shepherd University Wellness Center Parking Lot, 164 University Drive, Shepherdstown, WV

Lincoln County

9:00 AM 3:00 PM, Lincoln County Health Department, 8008 Court Avenue, Hamlin, WV (pre-registration: https://wv.getmycovidresult.com/)

Logan County

9:00 AM 9:45 AM, Man City Hall, 105 Market Street, Man, WV (pre-registration: https://wv.getmycovidresult.com/)

10:00 AM 10:45 AM, Kistler Grocery, 601 Buffalo Creek Road, Kistler, WV (pre-registration: https://wv.getmycovidresult.com/)

11:00 AM 11:45 AM, Ellis Supply, 234 Spirit Lane, Accoville, WV (pre-registration: https://wv.getmycovidresult.com/)

12:00 PM 12:45 PM, Buffalo Creek Fire Department, 70 Garrison Drive, Amherstdale, WV (pre-registration: https://wv.getmycovidresult.com/)

1:00 PM 1:45 PM, Buffalo Creek Apartments at Robinette, 40 Johnson Heights Drive, Robinette, WV (pre-registration: https://wv.getmycovidresult.com/)

2:00 PM 2:45 PM, Buffalo Creek Apartments at Crites, 175 Rendezvous Road, Lundale, WV (pre-registration: https://wv.getmycovidresult.com/)

3:00 PM 3:45 PM, Lorado Post Office, 9964 Buffalo Creek Road, Lorado, WV (pre-registration: https://wv.getmycovidresult.com/)

4:00 PM 4:45 PM, Curtis Church, 16541 Buffalo Creek Road, Lorado, WV (pre-registration: https://wv.getmycovidresult.com/)

Marshall County

10:00 AM 2:00 PM, Marshall County Health Department, 513 6th Street, Moundsville, WV (pre-registration: https://wv.getmycovidresult.com/)

Mineral County

10:00 AM 6:00 PM, Mineral County Health Department, 541 Harley O. Staggers Drive, Keyser, WV (pre-registration: https://wv.getmycovidresult.com/)

Monongalia County

9:00 AM 11:00 AM, WVU Recreation Center, lower level, 2001 Rec Center Drive, Morgantown, WV

Morgan County

11:00 AM 4:00 PM, Valley Health War Memorial Hospital, 1 Health Way, Berkeley Springs, WV

Pendleton County

11:00 AM 5:00 PM, Pendleton County Health Department, 273 Mill Road, Franklin, WV (pre-registration: https://wv.getmycovidresult.com/)

Preston County

4:00 PM 5:30 PM, Terra Alta EMS, 1124 East State Avenue, Terra Alta, WV (pre-registration: https://wv.getmycovidresult.com/)

Wayne County

10:00 AM 2:00 PM, Wayne Community Center, 11580 Rt. 152, Wayne, WV

For more free COVID-19 testing opportunities across the state, please visit https://dhhr.wv.gov/COVID-19/pages/testing.aspx.

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COVID-19 Daily Update 4-25-2021 - West Virginia Department of Health and Human Resources

The United States is deeply concerned by a massive surge in coronavirus cases in India and will race additional support to the Indian government and health care workers, a White House spokeswoman said on Saturday.

"We are in active conversations at high levels and plan to quickly deploy additional support to the Government of India and Indian health care workers as they battle this latest severe outbreak. We will have more to share very soon," the spokeswoman told Reuters via email.

Washington is under increasing pressure to do more to help India, the world's largest democracy and a strategic ally in President Joe Biden's efforts to counter China, as it grapples with a record-setting surge in coronavirus infections.

The U.S. Chamber of Commerce on Friday called on the Biden administration to release millions of stored doses of AstraZeneca (AZN.L) vaccine for shipment to India, Brazil and other hard hit countries.

The Indian government has deployed military planes and trains to get urgently needed oxygen to Delhi from other parts of the country and foreign countries, including Singapore.

The number of cases across the country surged by a record daily rise of 349,691 on Sunday, for a total of 16.96 million cases, including 192,311 deaths, the health ministry said.

The country of 1.3 billion people is on the brink of a humanitarian catastrophe, Ashish Jha, dean of the Brown University School of Public Health, warned in an op-ed published Saturday in the Washington Post.

He said some 2,000 people were dying daily, but most experts estimated that the true number was five to 10 times that level.

Officials from both countries are engaged at various levels to ensure a smooth supply of inputs and components from U.S. companies for production of COVID-19 vaccines in India, a spokesman at the Indian Embassy in Washington told Reuters.

He said it was important to work together to identify ways to overcome bottlenecks in medical supply chains and expedite ongoing vaccination efforts.

Jha called on Washington to send India oxygen, excess testing kits and high-quality personal protective equipment, including face masks, and medicines to treat COVID-19 patients, including sedatives and Remdesivir.

Jha also urged the Biden administration to share excess vaccines with India and other countries in crisis, citing some 30 million unused doses of the AstraZeneca vaccine that is in use elsewhere, but has not been authorized by U.S. regulators.

Washington should also lift export controls on raw materials put in place via the Defense Production Act and an associated export embargo in February, Jha wrote.

White House Press Secretary Jen Psaki on Friday said U.S. and Indian officials were working to find ways to help address the crisis, but gave no timetable for the support.

She said the United States has already provided India some $1.4 billion in health assistance, emergency relief supplies, pandemic training for Indian state and local health officials, and ventilators.

Our Standards: The Thomson Reuters Trust Principles.

More here:

U.S. racing to send aid to India as COVID-19 cases soar - Reuters India

Franketa A. Taylor, of Birmingham, was arrested in the U.S. Virgin Islands after authorities say she submitted an altered negative COVID-19 test to the U.S.V.I., online travel portal,according to a Virgin Islands Daily News report Friday.

The report states Taylor is facing charges including: fraudulent claims upon the government, access to a computer for fraudulent purposes, use of false information, and filing or recording forged instruments.

The U.S. Virgin Islands territory currently requires visitors to provide a negative COVID-19 test within five days of arrival, according to cbs42.com.

V.I. Daily News says Taylor is the seventh person thus far to be charged with entering an altered or forged COVID-19 test in the portal, which screens incoming travelers to prevent the spread of the virus.

According to Virgin Island Daily News, Taylor was unable to post her $5,500 bail and was turned over to the V.I. Bureau of Corrections pending an advice-of-rights hearing.

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Alabama woman arrested in Virgin Islands for providing false COVID-19 test - AL.com

Michigan and other states that experienced springtime Covid-19 surges or faced worrisome transmission trends appear to have turned a corner, with drops in new cases in recent days as vaccines reach more people.

After hovering at stubbornly high levels or increasing over the past two months, average daily cases in Massachusetts, Minnesota, New Jersey, Illinois, and other states in the Midwest and Northeast have started to fall, providing a breath of relief that the communities are past their most recent peaks. Crucially, new infections in Michigan which experienced the worst of the spring spikes, with some of its highest Covid-19 levels of the entire pandemic occurring in recent weeks have started declining, with hospitalizations also starting to tick down.

Experts are cautious that the progress has just begun and needs to be sustained if the states want to actually achieve low levels of transmission. But theyre heartened that it appears vaccines are increasingly not just protecting individuals from Covid-19, but are starting to have broader benefits for communities.

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Aprils been a bad month, said Preeti Malani, an infectious disease physician at the University of Michigan. There are hospitals across the state overwhelmed with patients. And because staff are sick, theyve been having trouble with staffing their hospitals. Different parts of the state remain under different levels of pressure, but now, with a big increase in vaccine availability in the past month, Malani said, Im optimistic about the direction were headed.

At the national level, the countrys average daily infection count has also started to come down, from more than 70,000 in the middle of April to closer to 60,000 now. But summarizing the U.S. Covid-19 epidemic from that frame obscures how much variability there is. After experiencing a horrific surge over the winter, California now has one of the lowest rates of infections in the country, while cases in Puerto Rico have increased over the past month.

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We remain in a complicated stage, Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said at a briefing Monday. On the one hand, more people in the United States are being vaccinated every single day at an accelerated pace. On the other hand, cases and hospitalizations are increasing in some areas of the country, and cases among young people who have not yet been vaccinated are also increasing.

The progress in the United States stands in stark contrast to most of the rest of the world, which lacks anything close to the vaccine supply this country has. Persistently high cases in Europe and the Americas and huge spikes in Asia have driven global case counts to among the highest levels of the whole pandemic.

Trends can also be moving in the right direction when, in raw numbers, infections are still high. Cases may be coming down in Michigan, but theyre still higher than they were there at just about at any other point in the pandemic. National case counts in the 60,000 range as opposed to the, say, 20,000 range mean that many more people will suffer severe outcomes from the coronavirus. And while death counts have dropped dramatically from the more than 3,000 people taken daily in the United States in stretches of January and February, the progress has been stalled at more than 700 deaths per day. The hope is that if case counts continue to fall over the coming weeks, deaths will follow in turn.

Already, the rollout of vaccines has dramatically changed the dynamics of the U.S. epidemic. Hospitalization and death rates among older adults the population with the highest immunization coverage have plummeted, while hospitalizations among younger adults have also started to come down more recently. Whereas for the first year of the pandemic hospitalizations and deaths would follow case counts in predictable patterns, experts now speak of vaccines decoupling those metrics because they are so powerfully protective against the worst outcomes of the disease.

But the shots arent just protecting individuals. Increasing evidence shows that they take a substantial bite out of transmission once theyre given to a certain swath of the population, as countries like Israel that have vaccinated most of their populations have demonstrated. Its not a specific threshold it will vary place to place depending on other factors but experts are hoping and anticipating that some places in the U.S. could be nearing that point, and drops in case counts could accelerate.

I think that might be whats happening in the Upper Midwest, said infectious disease physician Monica Gandhi of UCSF.

Experts had expected that the vaccine rollout would suppress Covid-19 come this summer, to such low levels that many of the activities weve forsaken over the past year could be done relatively safely.

But there was an intermediate hurdle: In some states, cases started rising again this spring, as politicians eased restrictions and individuals grew more relaxed. More transmissible variants of the coronavirus pushed cases up or slowed progress most notably B.1.1.7, which ignited major outbreaks in the United Kingdom (where it first emerged) and then in other European countries. Some recent transmission in New York and New Jersey also seems to have been driven by another variant, B.1.526.

The declining case counts in Michigan and other states suggest we may be back on track.

Im hopeful for that, epidemiologist Stephen Kissler of Harvards T.H. Chan School of Public Health said about the U.S. dodging the full brunt of B.1.1.7. Im cautiously optimistic.

One reason is that the weather got warmer, which appears to have an impact on transmission both for behavioral reasons (people spend more time outdoors) and perhaps for biological ones (many respiratory viruses lose some of their transmission efficiency in hotter, more humid temperatures). B.1.1.7-fueled spikes in the U.K. and Europe were exacerbated because they occurred over the colder months, for example.

The U.S. also had a big wall of natural immunity blunting just how widely the virus could spread this spring. Experts estimate that more than 100 million people in the country have recovered from an infection the vast majority of whom remain protected against reinfection for now.

And then, of course, vaccines. More than half of adults in the U.S. have received at least one dose of a vaccine, and a full third of adults are fully vaccinated.

The factors that spur outbreaks or slow them the weather, the number of susceptible people, the virus itself, the precautions people take can compound or counteract each other, and the plateaued national case count in recent weeks is a reflection of an almost even tug-of-war. But it appears that the balance in more places appears to be tilting toward declines.

Our optimism that the country as a whole has reached a clear turning point is further reinforced, modelers at Childrens Hospital of Philadelphias PolicyLab wrote in their latest update on Wednesday. This is great news for a Covid-weary nation, but we are mindful that the rates of improvement for some areas will be quicker than others.

For all the progress achieved with vaccines, the U.S. is reaching the point where supply is outpacing demand in a growing number of communities. The average number of daily vaccines administered reached a peak of nearly 3.2 million earlier this month, but has since fallen to 2.8 million, even as all people 16 and up became eligible for the shots. Its a matter of both access and hesitancy, and health officials at every level will increasingly have to reach people where they are or assuage their concerns to get more shots in arms. The University of Michigans Malani, for example, raised the concern that teens and young adults could drive outbreaks if theyre not incentivized to get vaccinated.

Experts still foresee a summer when vacations and barbecues return. The coronavirus wont be gone from the United States, but at what level it circulates and how much damage it inflicts in large part depends on how many people in each area remain unvaccinated. (Most children still wont be vaccinated this summer, but experts say that high levels of vaccine coverage among adults and lower transmission rates generally will reduce spread among children as well. Children overall are far less vulnerable to severe outcomes from Covid-19 than older adults, and appear to transmit the virus at lower levels.)

One trend experts will be keeping an eye on this summer is if there are echoes of summer 2020. While the warmer weather gives states in the northern part of the country some breathing room, last summer brought large outbreaks in places like Texas and Florida, where summer temperatures drive people into air-conditioned indoors. If there are large pockets of people who remain susceptible to Covid-19 in those places, they could potentially see a repeat increase in cases if on a significantly smaller scale this summer.

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States with springtime Covid-19 surges appear to have turned a corner - STAT

News Release

Friday, April 23, 2021

Enrollment begins at NIH Clinical Center.

A study assessing how people with immune system deficiencies or dysregulations respond to COVID-19 vaccination has begun enrolling participants at the National Institutes of Health Clinical Center in Bethesda, Maryland. The single-site study is led by researchers from the National Institute of Allergy and Infectious Diseases (NIAID) and aims to enroll 500 people, 400 with primary or secondary immune system disorders and 100 without such conditions.

Through large Phase 3 trials, several experimental COVID-19 vaccines were shown to be safe and effective and three are now authorized by the U.S. Food and Drug Administration for emergency use in the United States, said NIAID Director Anthony S. Fauci M.D. People with immune disorders are typically excluded from trials of experimental vaccines, and this was the case in the COVID-19 vaccine trials. This new study will characterize the features and adequacy of immune responses to COVID-19 vaccination in people with a range of immune deficiencies and dysregulation syndromes and will provide valuable information about benefits and potential risks in these individuals.

In addition to analyzing how they respond to vaccination, the study team will gather information about COVID-19 illness in people with immune deficiencies and dysregulation conditions.

Currently, there are few published studies on the incidence and clinical presentation of COVID-19 disease in people who have immune deficiencies, especially those who have inborn conditions involving deficits or dysregulations in antibody or cell-based immune responses to infections, said study principal investigator Emily Ricotta, Ph.D., MSc, of the NIAID Laboratory of Clinical Immunology and Microbiology. Our study aims to fill this knowledge gap.

Potential volunteers may be identified and invited to join the new study through existing NIH study protocol pools of healthy volunteers or via existing protocols involving persons with immune system disorders. Healthcare providers also may refer their patients with immune deficiencies or dysregulation conditions for enrollment. Initially, the study will enroll participants 16 years of age and older. If COVID-19 vaccines are authorized for use in younger people in the future, the enrollment age criterion could expand to include them.

All study visits can be conducted either in person at the NIH Clinical Center or remotely. Participants may be enrolled if they are completely or partially vaccinated against COVID-19. If a volunteer has not yet been vaccinated, they will provide a blood sample to investigators seven days prior to receipt of an FDA-authorized COVID-19 vaccine. Study participants can receive any authorized COVID-19 vaccine in their local communities. Depending on which manufacturers vaccine a participant receives, additional blood samples will be collected between 14 and 28 days after the first dose. Participants who receive vaccine that is administered as a two-dose regimen will provide an additional blood sample between 21 and 28 days after the second vaccine dose. Participants who receive the one-dose Johnson & Johnson COVID-19 vaccine will provide a single blood sample between 21 and 28 days after vaccination.

Blood sampled before and shortly after vaccination will be used to study short-term immunological effects of immunization. Participants have the option to provide additional samples approximately six, 12 and 24 months after the last dose. These samples will permit the researchers to assess the persistence of vaccine-induced antibodies and T-cell responses and to compare responses made by people with and without immune system disorders. If vaccine booster injections are recommended in the future, volunteers may choose to provide additional blood samples following those booster vaccines.

At enrollment, participants will be asked if they have been diagnosed with COVID-19 in the past and about symptom severity, using standardized questionnaires.

This will allow us to characterize the different manifestations of COVID-19 illness in the study population and to determine what influence these may have on the immune response to COVID-19 vaccination, said Dr. Ricotta.

Participants also will have the option to be screened for SARS-CoV-2 infections following vaccination using at-home saliva collection kits that they will return to the NIH biweekly for six months. (SARS-CoV-2 is the virus that causes COVID-19.) During multiple follow-up timepoints in the trial, participants will be asked about any vaccine-related adverse events, which will allow the study team to better understand safety and tolerability of the vaccines in people with specific immune deficiency or dysregulation disorders.

The information we gather on how well COVID-19 vaccines protect these specific populations and about any adverse events experienced by those with immune dysregulation or other disorders will aid decision-making about vaccination, said Steven Holland, M.D., director of the NIAID Division of Intramural Research, and the studys medically responsible principal investigator.

More information about the study is available at clinicaltrials.gov by searching on the identifier NCT04852276. Study staff may also be contacted by those interested in participating at NIAIDcovidvaccinestudy@niaid.nih.gov.

NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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COVID-19 vaccine responses to be studied in people with immune deficits - National Institutes of Health

News Release

Wednesday, April 21, 2021

A Phase 2/3 trial to evaluate a new fully-human polyclonal antibody therapeutic targeted to SARS-CoV-2, called SAB-185, has begun enrolling non-hospitalized people with mild or moderate cases of COVID-19. The trial, ACTIV-2, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The therapeutic was developed by SAB Biotherapeutics, Inc. (Sioux Falls, South Dakota).

NIHs Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program is a public-private partnership to develop a coordinated research strategy for speeding development of the most promising treatments and vaccine candidates. ACTIV-2 is a master protocol designed for evaluating multiple investigational agents in adults with mild-to-moderate COVID-19 who are not hospitalized. Led by the NIAID-funded AIDS Clinical Trials Group (ACTG) and supported by PPD (Wilmington, North Carolina), a global contract research organization that is responsible for trial execution, the trial will enroll participants at sites around the world.

The ACTIV-2 study design allows researchers to evaluate SAB-185 in a small group of volunteers and then continue testing it in a larger group if the antibody appears safe and effective. The trial began on Aug. 4, 2020 and has since added several therapeutics for testing.

SAB-185 is a fully-human polyclonal antibody therapeutic candidate for COVID-19 that has completed enrollment of Phase 1 and Phase 1b clinical studies. In previous pre-clinical studies, SAB-185 demonstrated neutralization of live SARS-CoV-2 at titers higher than convalescent plasma. The therapeutic candidate was developed from SABs platform, which uses genetically engineered cattle to produce fully-human antibodies in a process designed to potentially be both scalable and reliable.SAB-185 is administered intravenously, with the dose depending on the patients weight in kilograms (kg). A high and a low dose of SAB-185 will be tested in this trial.

When participants enroll in ACTIV-2, they will be assigned at random to receive either SAB-185, another therapeutic currently being evaluated in ACTIV-2, or a placebo. Other therapeutics currently being evaluated in ACTIV-2 include:

In the Phase 2 evaluation, each agent tested in ACTIV-2, and the shared placebo group, will enroll 110 participants with mild or moderate COVID-19 who are at risk for disease progression. The trial is blinded, so neither participants nor investigators will know whether a participant is receiving the therapeutic or the placebo. Participants will attend a series of clinic or at-home visits by clinicians and will be followed for a total of 72 weeks.

An independent Data and Safety Monitoring Board (DSMB) overseeing the trial will review the data collected at 28 days. They will monitor data to see if the therapy is safe, reduces the duration of COVID-19 symptoms and eliminates virus from the body. If there are no serious safety concerns and the results of this Phase 2 study seem promising, the trial will transition to Phase 3. It will then enroll 421 additional volunteers to receive the SAB agent, and 421 volunteers in the placebo group. The primary objective of the Phase 3 trial is to determine if the SAB therapy prevents either hospitalization or death by 28 days after study entry.

The study team for ACTIV-2 is led by protocol chairs Kara W. Chew, M.D., of the University of California, Los Angeles (UCLA), and Davey Smith, M.D., of the University of California, San Diego. Eric S. Daar, M.D., of UCLA, and David Wohl, M.D., of the University of North Carolina at Chapel Hill (UNC), serve as protocol vice-chairs. Babafemi Taiwo, MBBS of Northwestern University is a co-investigator focused on the SAB agent. The ACTG network is led by chair Judith Currier, M.D., (UCLA) and vice-chair Joseph Eron, M.D., of UNC.

For more information on this study, please visit http://www.riseabovecovid.org, or visit clinicaltrials.gov and search identifier NCT04518410.

NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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Large NIH clinical trial will test polyclonal antibody therapeutic for COVID-19 - National Institutes of Health