Infectious Disease

Interim outcomes recommend that an antibody cocktail reduces viral load in sufferers with COVID-19

January 03, 2021

2 min read

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Disclosure:
Weinreich reports that while conducting the study he received grants from BARDA as well as personal fees and other fees from Regeneron Pharmaceuticals outside of the work submitted. In the study you will find all relevant financial information from all other authors.

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Regeneron’s antibody cocktail reduced viral loads in patients with COVID-19, according to preliminary results from a small study recently published in the New England Journal of Medicine.

The REGN-COV2 cocktail showed “a greater effect in patients whose immune response had not yet been triggered or who had a high viral load at the start of the study,” the authors wrote.

“Our analysis suggests that an antibody cocktail against SARS-CoV-2 can also be an effective antiviral therapy that improves virus clearance and thus leads to improved results, especially in patients whose own immune response to the virus is only slowly triggered.” Daniel M. Weinreich, PhD, Professor of Ecology and Evolutionary Biology at Brown University and colleagues wrote. “Further studies, including the ongoing Phase 3 portion of this study, are needed to confirm these effects.”

In November, the FDA issued an Emergency Authorization (EUA) for REGN-COV2, which consists of the monoclonal antibodies casirivimab and imdevimab, for use in patients 12 years of age and older with a positive SARS-CoV-2 test who are at risk for that Progression to Severe COVID-19.

The Infectious Diseases Society of America does not recommend the routine use of another monoclonal antibody screening regimen, Bamlanivimab (Eli Lilly), which also received an EUA from the FDA in November but does not contain a specific recommendation for Regeneron products.

Weinreich and colleagues reported preliminary data from an ongoing phase 1-3 double-blind study conducted in non-hospitalized adult patients with COVID-19. The study is supported by Regeneron and the Biomedical and Advanced Research and Development Authority (BARDA) of HHS.

The analysis included results from 275 patients who were randomly assigned to receive either a placebo, 2.4 g REGN-COV2, or 8 g REGN-COV2. Weinreich and colleagues analyzed the safety, the time-weighted average changes in viral load from baseline from day 1 to day 7, and the number of patients with one or more COVID-19-related doctor visits by day 29.

Overall, the mean difference in time-weighted change in viral load between the two REGN-COV2 administered groups and the placebo group on days 1 through 7 in patients was -0.56 log10 copies / ml (95% CI, -1, 02 to -0.11) Weinreich and colleagues reported that no antibodies were present at the start of the study and -0.41 log10 copies / ml (95% CI, -0.71 to -0.10) in the entire study population.

A total of 6% of patients given placebo and 3% of patients given REGN-COV2 reported at least one medically attended visit. In a subset of subjects who were serum antibody negative at baseline, the difference was greater: 15% in the placebo arm and 6% in the treatment arms reported a medical visit.

“An important limitation of this intermediate section of our study is that although the analyzes

According to the antibody status, no formal hypothesis tests were performed to control the type I error. In addition, the baseline viral load analyzes were post hoc, ”the authors wrote. “These results should therefore be rigorously tested in the next analysis in this ongoing study.”

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