August 04, 2021
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O’Brien reports to be an employee and shareholder of Regeneron Pharmaceuticals.
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A single subcutaneous dose of Regeneron’s antibody cocktail prevents symptomatic COVID-19 and reduces the incidence of asymptomatic SARS-CoV-2 infection, according to a study published today in the New England Journal of Medicine.
The researchers said the results show that the REGEN-COV cocktail has the potential to be used as a long-term prophylaxis in people at risk for COVID-19.
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Last week the FDA expanded its emergency approval to use the cocktail, which contains the monoclonal antibodies casirivimab and imdevimab, for post-exposure prophylaxis. Data from the study published today was part of the package to support the expanded approval, Meagan O’Brien, MD, Regeneron’s senior director of early clinical development and clinical experimental science, told Healio.
Meagan O’Brien
“Monoclonal antibodies such as REGEN-COV can play an important complementary role to vaccines in post-exposure prophylaxis by providing rapid protection for people at high risk of progression to severe COVID-19 if they are not fully vaccinated or are not expected to be adequately vaccinated Response to vaccination and who a person infected with SARS-CoV-2 has been exposed to or at high risk of exposure from an infection that occurs in a common institutional setting such as nursing homes or prisons, “said O’Brien Healio notes that the Cocktail “is not a substitute for vaccination against COVID-19 and is not approved for pre-exposure prophylaxis for the prevention of COVID-19”.
O’Brien and colleagues conducted a randomized, double-blind, placebo-controlled study that included 1,505 participants who had been diagnosed with, and included in, SARS-CoV-2 infection with a household member in the past 96 hours Ratio 1: 1 to receive either a total dose of 1,200 mg REGEN-COV (n = 753) or placebo (n = 752).
The study consisted of a baseline screening and a 28-day efficacy assessment. It is completed with a 7 month follow-up.
The median age of the participants was 42.9 years, 45.9% were male, 9.3% were black, and 40.5% were identified as Hispanic or Latin American. The mean household size of the participants was three people. Of the 1,505 participants, 30.5% were at high risk for severe COVID-19.
Symptomatic COVID-19 (relative risk reduction) occurred in 11 of the 753 (1.5%) participants in the Regeneron group and 59 of 752 (7.8%) in the placebo group. [RRR], 81.4%; OR, 0.17).
Within the first week of the study, nine participants in the Regeneron group (1.2%) and 32 participants in the placebo group (4.3%) had symptomatic COVID-19 (RRR, 71.9%). In weeks 2 to 4, two participants in the Regeneron group (0.3%) and 27 in the placebo group (3.6%) had symptomatic COVID-19 (RRR, 92.6%).
Overall, 36 participants in the Regeneron group (4.8%) and 107 participants in the placebo group (14.2%; RRR 66.4%; OR 0.31) developed either asymptomatic or symptomatic COVID-19.
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