Coronavirus COVID-19 Update for March 19, 2021

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Antiviral Therapeutics and Vaccines

Lilly's bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19
Eli Lilly and Company announced new data from the randomized, double-blind, placebo-controlled BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths ("events") in high-risk patients recently diagnosed with COVID-19. These results provide additional efficacy and safety data that support the use of the dose recently granted both Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) and a positive scientific opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).This new Phase 3 cohort of BLAZE-1 included 769 high-risk patients, aged 12 and older with mild to moderate COVID-19 (therapy: n=511; placebo: n=258). There were four events in patients taking bamlanivimab with etesevimab and 15 events in patients taking placebo, representing an 87 percent risk reduction (p<0.0001). Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on key secondary endpoints. These results are consistent with those seen in other data sets from BLAZE-1: in the previous Phase 3 cohort, bamlanivimab 2800 mg with etesevimab 2800 mg reduced the risk of hospitalizations and deaths by 70 percent and in the Phase 2 cohort, bamlanivimab alone reduced the risk of hospitalizations and ER visits by approximately 70 percent. The viral load reductions were also consistent with what was observed in the previous Phase 3 cohort of the study.
Ridgeback Biotherapeutics and Merck Announce Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir
Merck and Ridgeback Biotherapeutics, LP today announced preliminary results from Ridgeback’s Phase 2a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and efficacy to eliminate SARS-CoV-2 viral RNA of molnupiravir (EIDD-2801/MK-4482), an investigational oral antiviral agent. The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. These preliminary findings were presented today during Science SpotlightsTM at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021). Findings from the primary efficacy and safety endpoints and additional secondary objectives will be presented at an upcoming medical meeting. This multi-center U.S. Phase 2a study enrolled 202 non-hospitalized adults who had signs or symptoms of COVID-19 within 7 days and confirmed active SARS-CoV-2 infection. The primary efficacy objective was reduction in time to viral negativity measured by reverse transcriptase polymerase chain reaction (RT-PCR) analysis of nasopharyngeal swabs. Periodic samples were collected for virologic analysis. Of the 182 participants with an evaluable nasopharyngeal swab, 42% (78/182) showed detectable levels of cultured virus at baseline. The full study results remain blinded and will be shared at a later date, as they become available. Other Phase 2 and Phase 2/3 studies are underway.
Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19A Randomized Clinical Trial
In this randomized clinical trial that included 476 patients, the duration of symptoms was not significantly different for patients who received a 5-day course of ivermectin compared with placebo (median time to resolution of symptoms, 10 vs 12 days; hazard ratio for resolution of symptoms, 1.07). The findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand effects on other clinically relevant outcomes.
Interim Public Health Recommendations for Fully Vaccinated People
This is the first set of public health recommendations for fully vaccinated people. This guidance will be updated and expanded based on the level of community spread of SARS-CoV-2, the proportion of the population that is fully vaccinated, and the rapidly evolving science on COVID-19 vaccines. For the purposes of this guidance, people are considered fully vaccinated for COVID-19 ≥2 weeks after they have received the second dose in a 2-dose series (Pfizer-BioNTech or Moderna), or ≥2 weeks after they have received a single-dose vaccine (Johnson and Johnson (J&J)/Janssen ).
- Fully vaccinated people can:
  - Visit with other fully vaccinated people indoors without wearing masks or physical distancing
  - Visit with unvaccinated people from a single household who are at low risk for severe COVID-19 disease indoors without wearing masks or physical distancing
  - Refrain from quarantine and testing following a known exposure if asymptomatic
- For now, fully vaccinated people should continue to:
  - Take precautions in public like wearing a well-fitted mask and physical distancing
  - Wear masks, practice physical distancing, and adhere to other prevention measures when visiting with unvaccinated people who are at increased risk for severe COVID-19 disease or who have an unvaccinated household member who is at increased risk for severe COVID-19 disease
  - Wear masks, maintain physical distance, and practice other prevention measures when visiting with unvaccinated people from multiple households
  - Avoid medium- and large-sized in-person gatherings
  - Get tested if experiencing COVID-19 symptoms
  - Follow guidance issued by individual employers
  - Follow CDC and health department travel requirements and recommendations

Diagnostics

Coronavirus (COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next generation sequencing based (NGS) test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2. The test analyzes DNA (deoxyribonucleic acid) sequences from T cells (white blood cells) to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection. A positive test result indicates recent or prior infection with SARS-CoV-2, while a negative test result indicates that a patient is unlikely to have been infected with SARS-CoV-2. Negative results do not preclude acute or current SARS-CoV-2 infection. All results from the test should be used in combination with a clinical examination, patient medical history and other findings. The T-Detect COVID Test should not be used to diagnose current SARS-CoV-2 infection.

Epidemiology

Estimated SARS-CoV-2 Seroprevalence Among Persons Aged <18 Years — Mississippi, May–September 2020
Serosurveys estimating prior SARS-CoV-2 infections in the United States have focused on adults; little is known about seroprevalence among young persons. Serologic testing of residual blood specimens collected during May–September 2020, from 1,603 persons aged <18 years suggested that approximately 113,842 (16.3%) of 698,420 young persons in Mississippi might have been infected with SARS-CoV-2 by mid-September 2020, and only 8,993 confirmed and probable COVID-19 cases among young persons had been reported to the Mississippi State Department of Health by August 31. Serosurveys including pediatric age groups help estimate cumulative disease incidence and frequency of undiagnosed cases of COVID-19 among young persons to guide prevention efforts.