Cluster: COVID-19

Cluster: COVID-19

A cluster of topics related to COVID-19. COVID-19 is the abbreviated name for coronavirus disease 2019, a respiratory disease caused by a novel coronavirus strain called SARS-CoV-2. COVID-19 was first detected in Wuhan City, China and the outbreak was declared a pandemic on March 11, 2020 by the WHO.

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Edits on 20 Nov, 2020
Meredith Hanel
Meredith Hanel edited on 20 Nov, 2020
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Baricitinib in combination with remdesivir

The FDA issued an EUA on November 19, 2020 for the combination treatment of baricitinib together with the FDA approved drug remdesivir for treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation or extracorpeal membrane oxygenation (ECMO).

Edits on 10 Nov, 2020
Charley Baker
Charley Baker edited on 10 Nov, 2020
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Bacillus Calmette-Guérin (BCG) vaccination (typically given at birth and/or during childhood) was intended to target tuberculosis caused by the bacteria Mycobacterium tuberculosis and has been reported to also protect against various other infectious diseases. BCG vaccine is under investigation for benefits against SARS-CoV-2. The WHO stated that there is no evidence that BCG protectionprotects people from coronavirus infection.

Edits on 30 Oct, 2020
Jude Gomila
Jude Gomila edited on 30 Oct, 2020
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Gamaleya Research Institute of Epidemiology and Gamaleya Research Institute of Epidemiology and MicrobiologyMicrobiology (Russia)

Edits on 23 Oct, 2020
Neelam Jhaveri
Neelam Jhaveri approved a suggestion from Golden's AI on 23 Oct, 2020
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Remdesivir

Remdesivir

Neelam Jhaveri
Neelam Jhaveri approved a suggestion from Golden's AI on 23 Oct, 2020
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Remdesivir is an experimental drug approved by the US FDA on October 22, 2020 which has been shown to shorten the time to recovery from SARS-CoV-2 infection by interfering with viral replicationviral replication.

Meredith Hanel
Meredith Hanel edited on 22 Oct, 2020
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Approved treatments

Remdesivir

Remdesivir received US FDA approval on October 22, 2020 for treatment of COVID-19. Remdesivir , a Nuc inhibitor drug that inhibits viral replication, was granted emergency use authorization by the FDA on May 1, 2020. Gilead announced the submission of their New Drug Application (NDA) for remdesivir to treat COVID-19 under the product name Veklury in August 2020. An expansion of the EUA issued on August 28, 2020 allows Veklury to be provided to hospitalized patients irrespective of disease severity. Ongoing Phase 3 Clinical Trials for remdesivir are NIAID ACTT-1 Trial, Gilead GS-US-540-5773 Trial and Gilead GS-US-540-5774 Trial.

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Remdesivir

Remdesivir , a Nuc inhibitor drug that inhibits viral replication, was granted emergency use authorization by the FDA on May 1, 2020. Gilead announced the submission of their New Drug Application (NDA) for remdesivir to treat COVID-19 under the product name Veklury in August 2020. An expansion of the EUA issued on August 28, 2020 allows Veklury to be provided to hospitalized patients irrespective of disease severity. Ongoing Phase 3 Clinical Trials for remdesivir are NIAID ACTT-1 Trial, Gilead GS-US-540-5773 Trial and Gilead GS-US-540-5774 Trial.

Meredith Hanel
Meredith Hanel edited on 22 Oct, 2020
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Remdesivir is an experimental drug approved by the US FDA on October 22, 2020 which has been shown to shorten the time to recovery from SARS-CoV-2 infection by interfering with viral replication.

As of September 1, 2020 thereThere are no FDA-approved medicines approved for treatment or prevention of COVID-19 and no FDA regulated vaccines for prevention of COVID-19.Treatments in development for COVID-19 focus on three primary areas: symptoms, anti-inflammation, and anti-viral growth. Certain treatments (below) have been granted FDA emergency use authorization (EUA) for the treatment of COVID-19. EUA authorizations may allow unapproved medical products or the use of approved medical products for unapproved uses in an emergency to diagnose, treat or prevent serious or life-threatening conditions or diseases. Potential drug and vaccine targets include proteins, enzymes, processes that allow virus entry into cells or virus replication and immune system regulatory pathways.

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COVID-19 potential treatments and interventions

Treatment / intervention
Company/Team
Stage
Other uses
Mechanism of action

Remdesivir (GS-7734)

Clinical trials, Phase 3, EUA (FDA), FDA approved

Ebola, feline corona viruses

Nuc inhibitor, metabolizes to form an adenosine analog, targets viral RNA dependent RNA polymerase

Edits on 14 Oct, 2020
Henry Ogolla
Henry Ogolla approved a suggestion from Golden's AI on 14 Oct, 2020
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COVID-19 diagnostic testing is performed on sputum, nose, and throat swabs. In early March 2020, governments restricted COVID-19 testing to central health agencies or a few accredited laboratories for a real-time reverse-transcription PCR (RT-PCR)-based protocol selected by the WHO. Reverse transcription means a reverse transcriptase enzyme is used to convert RNA template to cDNA before PCR amplification which produces a large number of copies of the cDNA. Real-time PCR is sometimes called quantitative PCR (qPCR or qRT-PCR). Tests that use PCR are also referred to as nucleic acidnucleic acid amplification tests (NAAT) as they amplify deoxyribonucleic acid (DNA). The COVID-19 real-time RT-PCR test detects the presence of the E gene of SARS-CoV-2, coding for the envelope surrounding the viral shell and the gene for the enzyme RNA-dependent RNA polymerase. Once samples are received in a laboratory, it takes 24-48 hours for results. The tests were confirmed to be accurate with whole genome sequencing. The US Centers for Disease Control and Prevention (CDC) has an RT-PCR assay that includes primers for the nucleocapsid phosphoprotein in the virus shell and for the RNA-dependent RNA polymerase gene. In the UK, COVID-19 testing is done by accredited laboratories. In the US COVID-19 testing was initially done exclusively by the CDC which later began sending out RT-PCR test kits to state health laboratories. Some clinical tests on sale in the US were made available under CLIA waivers, which regulate the facility where the tests are conducted, rather than the tests themselves. The FDA announced on February 29 that CLIA-certified labs do not need to obtain emergency use authorization (EUA).

Meredith Hanel
Meredith Hanel edited on 14 Oct, 2020
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Various countries or region of countries mandated masks to be worn in public spaces to slow the spread of COVID-19. In the United States a nation-wide, federal-level mask order is not possible due to the sovereignty of U.S. states. Accordingly, U.S. states specify their own local policies and regulations around wearing masks. Some states require that masks be worn in certain public settings (such as inside businesses) while others have enacted no such requirements.

Edits on 14 Oct, 2020
Meredith Hanel
Meredith Hanel edited on 14 Oct, 2020
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According to available evidence, the SARS-CoV-2 virus is transmitted between people through close contact and droplets produced by sneezing and coughing. The SARS-CoV-2 virus was initially reported to not be transmitted by airborne transmission, but hundreds of scientists urged organizations such as the WHO to address airborne transmission in an open letter outlining emerging evidence, which culminated in a National Academies workshop on airborne transmission of COVID-19. Preventative measures include: hand hygiene with alcohol-based sanitizers or soap and water; avoiding touching eyes, nose and mouth; coughing or sneezing into elbow or tissue; wearing a medical mask if you have symptoms and hand hygiene after disposing of mask; maintaining social distance of 1 m from individuals with respiratory symptoms. In indoor environments, ventilation, filtration and air disinfection have been suggested to decrease potential airborne transmission. See COVID-19 transmission dynamics and COVID-19 protocols for more information on disease transmission and mitigation strategies respectively which include nonpharmaceutical interventions (NPIs) .

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Masks can be used as personal protective equipment (PPE) to keep the wearer of the mask from breathing in SARS-CoV-2 virus. Masks are also used as a respiratory source control where the aim is the protect others from exposure to exhaled viral particles. Standards, protocols and methods for testing masks are found on the Mask Testing Protocols page.

Health care setting

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Masks for the general public

The purchasing of protective face masks by the public is feared to cause a shortage for health care workers during the COVID-19 pandemic. In addition to healthcare workers, a shortage of protective masks would slow scientific research on treatments and vaccines to SARS-CoV-2 since personnel need to be protected from the pathogens that they work with in the lab. For healthy asymptomatic individuals, who are not healthcare workers or caring for patients at home, wearing of a face mask iswas initially not recommended by the WHO. The WHO stated on February 27, 2020, “The capacity to expand PPE production is limited, and the current demand for respirators and masks cannot be met, especially if the widespread, inappropriate use of PPE continues”, referring to surges in global demand driven by misinformation, panic buying and stockpiling. The WHO changed their stance in June 2020 to state that those over 60 or with medical conditions should wear a medical -grade mask when in public when physical distancing is not possible and that the general public should wear three-layer fabric masks in those situations. The WHO advised governments to encourage mask wearing on public transport, in shops or other confined areas.

Meredith Hanel
Meredith Hanel edited on 14 Oct, 2020
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COVID-19 diagnostic testing is performed on sputum, nose, and throat swabs. In early March 2020, governments restricted COVID-19 testing to central health agencies or a few accredited laboratories for a real-time reverse-transcription PCR (RT-PCR)-based protocol selected by the WHO. Reverse transcription means a reverse transcriptase enzyme is used to convert RNA template to cDNA before PCR amplification which produces a large number of copies of the cDNA. Real-time PCR is sometimes called quantitative PCR (qPCR or qRT-PCR). Tests that use PCR are also referred to as nucleic acid amplification tests (NAAT) as they amplify deoxyribonucleic acid (DNA). The COVID-19 real-time RT-PCR test detects the presence of the E gene of SARS-CoV-2, coding for the envelope surrounding the viral shell and the gene for the enzyme RNA-dependent RNA polymerase. Once samples are received in a laboratory, it takes 24-48 hours for results. The tests were confirmed to be accurate with whole genome sequencing. The US Centers for Disease Control and Prevention (CDC) has an RT-PCR assay that includes primers for the nucleocapsid phosphoprotein in the virus shell and for the RNA-dependent RNA polymerase gene. In the UK, COVID-19 testing is done by accredited laboratories. In the US COVID-19 testing was initially done exclusively by the CDC which later began sending out RT-PCR test kits to state health laboratories. Some clinical tests on sale in the US were made available under CLIA waivers, which regulate the facility where the tests are conducted, rather than the tests themselves. The FDA announced on February 29 that CLIA-certified labs do not need to obtain emergency use authorization (EUA).

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The US FDA issued an EUA for the serology point-of-care (POC) test, Assure COVID-19 IgG/IgM Rapid Test Device in July 2020 for certain laboratories and reissued the EUA in September 2020 for use with fingerstick blood samples in POC settings like a doctor’s office or urgent care centers without the need for sending samples to a central lab. The WHO supports the use of tests for SARS-CoV-2 antibodies at a population level or in specific groups to help understand the risk associated with infection and data about the percentage of people with detectable COVID-19 antibodies. It is not known if people with SARS-CoV-2 antibodies are immune to secondary infections. Antibody tests can check if a person has previously been infected with SARS-CoV-2 but are not recommended to diagnose current infection because it may take 1-3 weeks for the body to produce detectible antibodies.

Meredith Hanel
Meredith Hanel edited on 14 Oct, 2020
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Types of SARS-CoV-2 tests

COVID-19 diagnostic testing is performed on sputum, nose, and throat swabs. As ofIn early March 2020, governments have restricted COVID-19 testing to central health agencies or a few accredited laboratories for a real-time reverse-transcription PCR (RT-PCR)-based protocol selected by the WHO. Reverse transcription means a reverse transcriptase enzyme is used to convert RNA template to cDNA before PCR amplification which produces a large number of copies of the cDNA. Real-time PCR is sometimes called quantitative PCR (qPCR or qRT-PCR). Tests that use PCR are also referred to as nucleic acid amplification tests as they amplify deoxyribonucleic acid (DNA). The COVID-19 real-time RT-PCR test detects the presence of the E gene of SARS-CoV-2, coding for the envelope surrounding the viral shell and the gene for the enzyme RNA-dependent RNA polymerase. Once samples are received in a laboratory, it takes 24-48 hours for results. The tests arewere showingconfirmed to be accurate by confirmation with whole genome sequencing. The US Centers for Disease Control and Prevention (CDC) has an RT-PCR assay that includes primers for the nucleocapsid phosphoprotein in the virus shell and for the RNA-dependent RNA polymerase gene. In the UK, COVID-19 testing is done by accredited laboratories. In the US COVID-19 testing was initially done exclusively by the CDC which later began sending out RT-PCR test kits to state health laboratories. Some clinical tests on sale in the US have beenwere made available under CLIA waivers, which regulate the facility where the tests are conducted, rather than the tests themselves. The FDA announced on February 29 that CLIA-certified labs do not need to obtain emergency use authorisationauthorization (EUA).

Besides real-time RT-PCR, other diagnostic tests being developed use CRISPR- or antibody-based methods or serological tests such as ELISA and lateral flow immunoassay. Antibodies can be used as probes to detect virus. For serological tests, antibodies produced by a person exposed to the virus are detected in blood samples. Antibodies are still found in patients after they recover from the illness.

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As of April, 2020, the majority of COVID-19 nucleic acid tests use real-time RT-PCR that targets ORF1b, ORF8, nucleocapsid (N), spike (S) protein, RNA-dependent RNA polymerase (RdRP) or envelope (E) genes of SARS-CoV-2. Samples tested are usually swabs from the upper respiratory system but it is possible to use serum, stool, ocular secretions or saliva. There are nucleic acid amplification tests that use CRISPR and isothermal amplification.

Besides detecting viral RNA, other diagnostic tests being developed to detect viral protein or antibodies produced by a person infected with SARS-CoV-2 using antibody-based methods or serological tests such as ELISA and lateral flow immunoassay. Antibodies may be used as probes to detect viral protein. For serological tests, antibodies produced by a person exposed to the virus are detected in blood samples. Antibodies are still found in patients after they recover from the illness.

Edits on 9 Oct, 2020
Meredith Hanel
Meredith Hanel edited on 9 Oct, 2020
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  • CanSino Biologics/Beijing Institute of Biotechnology/Petrovax for Ad5-nCoV
Meredith Hanel
Meredith Hanel edited on 9 Oct, 2020
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Vaccines developed for other diseases

Bacillus Calmette-Guérin (BCG) vaccination (typically given at birth and/or during childhood) was intended to target tuberculosis caused by the bacteria Mycobacterium tuberculosis and has been reported to also protect against various other infectious diseases. BCG vaccine is under investigation for benefits against SARS-CoV-2. The WHO stated that there is no evidence that BCG protection people from coronavirus infection.

Meredith Hanel
Meredith Hanel edited on 9 Oct, 2020
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  • University of Oxford/AstraZeneca
  • Sinovac
  • University of Oxford/AstraZeneca for ChAdOx1 nCoV-19, adenovirus containing spike protein
  • Sinovac for CoronaVac, whole inactivated SARS-CoV-2
  • Sinopharm, whole inactivated SARS-CoV-2
  • BioNTech/Fosun Pharma/Pfizer for BNT162b2
  • Moderna/NIAID
  • Moderna/NIAID for mRNA-1273
  • Janssen Pharmaceutical Companies of Johnson & Johnson/NIAID/BARDA for JNJ-78436735
  • Novavax for NVX-CoV2373, bioengineered spike protein
Meredith Hanel
Meredith Hanel edited on 9 Oct, 2020
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Hydroxychloroquine EUA for chloroquine phosphate and hydroxychloroquine sulfate was revoked on June 15, 2020 based on review of further scientific evidence.Hydroxychloroquine sulfate and chloroquine phosphate products were granted EUA authorization by the FDA on March 28, 2020. Chloroquine is a quinoline derivative and a drug in widespread use since 1945 for the treatment of malaria, autoimmune diseases, and other medical conditions. Chloroquine is being investigated to treat COVID-19 in the form of chloroquine phosphate or hydroxychloroquine sulfate which are sometimes referred to as chloroquine and hydroxychloroquine respectively. EUA for chloroquine phosphate and hydroxychloroquine sulfate was revoked on June 15, 2020 based on review of further scientific evidence.

Meredith Hanel
Meredith Hanel edited on 9 Oct, 2020
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COVID-19 potential treatments

The following COVID-19 treatments are experimental or in development unless otherwise specified. Treatments may have emergency use authorization from the FDA while still in an experimental stage. Some drugs designed and approved to treat other diseases are being tested for COVID-19.

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COVID-19 potential treatments

The following COVID-19 treatments are experimental or in development unless otherwise specified. Treatments may have emergency use authorization from the FDA while still in an experimental stage. Some drugs designed and approved to treat other diseases are being tested for COVID-19.

Meredith Hanel
Meredith Hanel edited on 9 Oct, 2020
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Vaccines

Commissioner Dr. Stephen Hahn stated that the FDA may consider EUA of a vaccine before trials are complete. Director of the Infectious Diseases Division of Vanderbilt University Dr. David Aronoff and others voiced concerns about not waiting until clinical trials are complete and reviewed. The FDA issued guidance document for Emergency Use Authorization for COVID-19 vaccines in October 2020 which states that before seeking emergency approval, vaccine makers should follow trial participants for at least two months to rule out major side effects. CDC director Robert Redfield, vaccine developers and the FDA stated that a COVID-19 vaccine is unlikely to be widely available until the middle of 2021.

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Emergency Use Authorization

Commissioner Dr. Stephen Hahn stated that the FDA may consider EUA of a vaccine before trials are complete. Director of the Infectious Diseases Division of Vanderbilt University Dr. David Aronoff and others voiced concerns about not waiting until clinical trials are complete and reviewed. The FDA issued guidance document for Emergency Use Authorization for COVID-19 vaccines in October 2020 which states that before seeking emergency approval, vaccine makers should follow trial participants for at least two months to rule out major side effects. CDC director Robert Redfield, vaccine developers and the FDA stated that a COVID-19 vaccine is unlikely to be widely available until the middle of 2021.

Meredith Hanel
Meredith Hanel edited on 9 Oct, 2020
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As of September 1, 2020 there are no FDA-approved medicines approved for treatment ofor prevention of COVID-19 and no FDA regulated vaccines for prevention of COVID-19.Treatments in development for COVID-19 focus on three primary areas: symptoms, anti-inflammation, and anti-viral growth. Certain treatments (below) have been granted FDA emergency use authorization (EUA) for the treatment of COVID-19. EUA authorizations may allow unapproved medical products or the use of approved medical products for unapproved uses in an emergency to diagnose, treat or prevent serious or life-threatening conditions or diseases. Potential drug and vaccine targets include proteins, enzymes, processes that allow virus entry into cells or virus replication and immune system regulatory pathways.

...

Commissioner Dr. Stephen Hahn stated that the FDA may consider EUA of a vaccine before trials are complete. Director of the Infectious Diseases Division of Vanderbilt University Dr. David Aronoff and others voiced concerns about not waiting until clinical trials are complete and reviewed. The FDA issued guidance document for Emergency Use Authorization for COVID-19 vaccines in October 2020 which states that before seeking emergency approval, vaccine makers should follow trial participants for at least two months to rule out major side effects. CDC director Robert Redfield, vaccine developers and the FDA stated that a COVID-19 vaccine is unlikely to be widely available until the middle of 2021.

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The following groups have COVID-19 vaccines in Phase 3 clinical trials (as of Augustupdated 31,October 2020):

Beijing Institute of Biological Products/Sinopharm

  • Beijing Institute of Biological Products/Sinopharm
  • Janssen Pharmaceutical Companies of Johnson & Johnson/NIAID/BARDA
Edits on 17 Sep, 2020
Meredith Hanel"adding references"
Meredith Hanel edited on 17 Sep, 2020
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According to available evidence, the SARS-CoV-2 virus is transmitted between people through close contact and droplets produced by sneezing and coughing. The SARS-CoV-2 virus was initially reported to not be transmitted by airborne transmission, but hundreds of scientists haveurged sinceorganizations slammedsuch as the WHO and CDC for their failure to correctaddress thisairborne transmission in lightan ofopen letter outlining emerging evidence, which culminated in a National Academies workshop on airborne transmission of COVID-19. Preventative measures include: hand hygiene with alcohol-based sanitizers or soap and water; avoiding touching eyes, nose and mouth; coughing or sneezing into elbow or tissue; wearing a medical mask if you have symptoms and hand hygiene after disposing of mask; maintaining social distance of 1 m from individuals with respiratory symptoms. In indoor environments, ventilation, filtration and air disinfection have been suggested to decrease potential airborne transmission.

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