Literature Highlights

Each week, we provide COVID-19 research article summaries and the main highlights in an infographic. Please come back weekly for more updated pandemic infographic highlights covering diagnosis, risk factors, treatment, and more.

  • Reduced sensitivity of SARS-CoV-2 variant Delta to antibody neutralization

  • Effect of ivermectin on time to resolution of symptoms among adults with mild COVID-19: A randomized clinical trial

  • Evaluation of seropositivity following BNT162b2 messenger RNA vaccination for SARS-CoV-2 in patients undergoing treatment for cancer

  • Subcutaneous REGEN-COV antibody combination to prevent COVID-19

  • Effectiveness of COVID-19 vaccines against the B.1.617.2 (delta) variant

  • Neutralizing capacity against Delta (B.1.617.2) and other variants of concern following Comirnaty (BNT162b2, BioNTech/Pfizer) vaccination in health care workers, Israel

  • Prevention and attenuation of COVID-19 with the BNT162b2 and mRNA-1273 vaccines

  • Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomized, controlled, open-label, platfom trial

  • Tackling COVID-19 with neutralizing monoclonal antibodies

  • Myocarditis following COVID-19 mRNA vaccination

  • Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-dimer concentration (ACTION): an open-label, multicenter, randomized, controlled trial

  • 6-month consequences of COVID-19 in patients discharged from hospital: A cohort study

  • Interim Results of a Phase 1–2a Trial of Ad26.COV2.S COVID-19 Vaccine

  • ‘Long-COVID’: a cross-sectional study of persisting symptoms, biomarker and imaging abnormalities following hospitalisation for COVID-19

  • Preliminary Findings of mRNA COVID-19 Vaccine Safety in Pregnant Persons

  • Tocilizumab in Patients Hospitalized with COVID-19 Pneumonia

  • Interleukin-6 Receptor Antagonists in Critically III Patients with COVID-19

  • Prospective Mapping of Viral Mutations That Escape Antibodies Used to Treat COVID-19

  • Early High-Titer Plasma Therapy to Prevent Severe COVID-19 in Older Adults

  • Antibody Resistance of SARS-CoV-2 Variants B.1.351 and B.1.1.7

  • Interim Results of a Phase 1-2a Trial of Ad26.COV2.S COVID-19 Vaccine

  • Baricitinib plus Remdesivir for Hospitalized Adults with COVID-19

  • Safety and Immunogenicity of an Inactivated SARS-CoV-2 Vaccine, BBIBP-CorV: A Randomized, Double-Blind, Placebo-Controlled, Phase 1/2 Trial

  • REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with COVID-19

  • Pre-pandemic Psychiatric Disorders and Risk of COVID-19: A UK Biobank Cohort Analysis

  • Baricitinib Therapy in COVID-19: A Pilot Study on Safety and Clinical Impact

  • SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with COVID-19

  • Safety and Immunogenicity of Two RNA-Based COVID-19 Vaccine Candidates

  • Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial

  • Therapeutic Versus Prophylactic Anticoagulation for Severe COVID-19: A Randomized Phase II Clinical Trial (HESACOVID)

  • Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults

  • Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine

  • Effects of COVID-19 on the Nervous System

  • COVID-19 Vaccine: A Comprehensive Status Report

  • Extrapulmonary Manifestations of COVID-19

  • Physical Distancing, Face Masks, and Eye Protection to Prevent Person-to-Person Transmission of SARS-CoV-2 and COVID-19: A Systematic Review and Meta-Analysis

  • Dexamethasone in Hospitalized Patients with COVID-19-Preliminary Report

  • Safety and Immunogenicity of the ChAdOx1 nCoV-19 Vaccine Against SARS-CoV-19: A Preliminary Report of a Phase 1/2, Single-Blind, Randomized Controlled Trial

  • An mRNA vaccine Aganist SARS-CoV-2 – Preliminary Report

  • Triple Combination of Interferon Beta-1b, Lopinavir-Ritonavir, and Ribavirin in the Treatment of Patients Admitted to Hospital With COVID-19: An Open-Label, Randomised, Phase 2 Trial

  • Pilot Prospective Open, Single-arm Multicentre Study on Off-label Use of Tocilizumab in Patients With Severe COVID-19

  • Observational Study of Hydroxychlaraquine in Hospitalized Patients with COVID-19

  • Clinical and Immunological Assessment of Asymptomatic SARS-CoV-2 Infections

  • Paediatric Inflammatory Multisystem Syndrome: Temporally Associated with SARS-CoV-2 (PIMS-TS): Cardiac Features, Management and Short-Term Outcomes at a UK Tertiary Paediatric Hospital

  • Biomarkers Associated with COVID-19 Disease Progression

  • Remdesivir for the Treatment of COVID-19 – Preliminary Report

  • A Comparative Study on the Clinical Features of COVID-19 Pneumonia to Other Pneumonias

  • Association of Blood Glucose Control and Outcomes in Patients with COVID-19 and Pre-existing Type 2 Diabetes

  • Candidate drugs against SARS-CoV-2 and COVID-19

Menu

Updates in the Treatment and Prevention of COVID-19​

EUA of Bamlanivimab Plus Etesevimab Expanded to Include Younger Pediatric Patients

The emergency use authorization (EUA) for bamlanivimab plus etesevimab now includes an indication for treatment and post-exposure prophylaxis for children and newborn babies who are at high risk for severe disease. The expansion of the EUA is supported by a trial of 125 pediatric patients with at least one risk factor for severe illness; the study had safety and efficacy data similar to findings for adolescents and adults.

For more information visit www.fda.gov/news-events/press-announcements/fda-expands-authorization-two-monoclonal-antibodies-treatment-and-post-exposure-prevention-covid-19

 

Oral Antiviral Therapies With Emergency Use Authorization (EUA) for COVID-19

Two new oral antiviral therapies received emergency use authorization (EUA) for COVID-19: Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) and molnupiravir. Both therapies are authorized for the treatment of mild-to-moderate COVID-19 in certain people who are at high risk of progressing to severe illness.

In the EPIC-HR clinical trial, nirmatrelvir/ritonavir significantly reduced the risk of hospitalization or death from any cause by 88% compared with placebo. This treatment is indicated for adults and pediatric patients, 12 years of age and older who weigh at least 40 kilograms. Side effects include an impaired sense of taste, diarrhea, high blood pressure, and muscle aches. The safety and effectiveness of this combination therapy continue to be evaluated.

The main outcome measure of the MOVe-OUT trial of molnupiravir was the percentage of people who were hospitalized or died due to any cause during 29 days of follow-up. Compared with 9.7% of people who received placebo, 6.8% of those in the molnupiravir group were hospitalized or died. One person who received molnupiravir died versus nine people in the placebo group. Molnupiravir is not recommended for pregnant women or for those people younger than 18 years of age because of its effect on bone and cartilage growth.

For more information regarding the EUA for these oral antivirals, visit the following FDA URLs:

www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19

www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain

 

FDA Authorized Emergency Use Authorization (EUA) for Long-Acting Monoclonal Antibodies as Pre-Exposure Prophylaxis of COVID-19

Evusheld (tixagevimab co-packaged with cilgavimab and administered together) has been granted EUA for the prevention of COVID-19 in certain people with compromised immune systems or with a history of severe adverse reactions to a COVID-19 vaccine or any of its components. This combination is not meant to be a substitute for vaccination for those who have no contraindications to a COVID-19 vaccine.

The PROVENT clinical trial demonstrated a 77% reduction in the risk of developing COVID-19 compared with placebo, and protection appears to have been maintained through six months. Safety and efficacy of the tixagevimab/cilgavimab combination continues to be investigated.

For more information, visit www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure