The first phase 3 trial (2069A) evaluated the ability of REGEN-COV to reduce the risk and burden of COVID-19 infection among household contacts of people infected with SARS-CoV-2. The trial showed that SC administration of 1,200 mg REGEN-COV reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial. The Phase 3, double-blind, placebo-controlled trial evaluated the effect of REGEN-COV in uninfected individuals without anti-SARS-CoV-2 antibodies or any symptoms of COVID-19, living in the same household as an individual who tested positive for SARS-CoV-2 within the previous four days. The trial recruited 1,505 people who were not infected with SARS-CoV-2 at the start of the study and were randomized to receive a dose of REGEN-COV (1,200 mg) or a placebo, administered as subcutaneous injections. On average, REGEN-COV-treated individuals who experienced a symptomatic infection resolved their symptoms within one week, compared to 3 weeks with placebo. Infected people also cleared the virus faster with REGEN-COV.
The second phase 3 trial (2069B) of recently infected asymptomatic COVID-19 patients, evaluating 1,200 mg of REGEN-COV administered subcutaneously, found that REGEN-COV reduced the overall risk of progressing to symptomatic COVID-19 in a 31% (primary endpoint) and 76% after the third day. The trial also showed that REGEN-COV shortened the duration of symptoms and markedly reduced viral levels. The trial recruited 204 people without any COVID-19 symptoms, who tested positive for SARS-CoV-2 but did not have antiviral antibodies at the start of the study, and were randomized to receive a dose of REGEN-COV (1,200 mg) or a placebo.
The trial met all key primary and secondary endpoints. In addition to reducing the risk of symptomatic infections, the total number of weeks that patients experienced symptoms was reduced by almost half (45%) with REGEN-COV, and viral load was reduced by more than 90%. Although it was not included in the initial analysis plan, the researchers also found that none of the REGEN-COV patients and six placebo patients were hospitalized or visited the emergency room due to COVID-19 during the period of 29-day efficacy evaluation.
“These data suggest that REGEN-COV can complement widespread vaccination strategies, particularly for those at high risk of infection. Importantly, to date, REGEN-COV in vitro has been shown to retain its potency against emerging COVID-19 variants that are of concern, ”said Myron Cohen, MD, who leads monoclonal antibody efforts to the NIH sponsored COVID Prevention Network (CoVPN) and is director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill. “Despite standard precautions to reduce transmission, almost 10% of unvaccinated people living with an infected person developed symptomatic infections if they did not receive REGEN-COV. If authorized, convenient subcutaneous administration of REGEN-VOC could help control outbreaks in high-risk settings where people have not yet been vaccinated, including individual households and community living settings. “
“Transmission of COVID-19 occurs frequently through infected people who do not yet have symptoms, so it is critical that we quickly diagnose and treat these people for their own health and to prevent transmission,” said Katharine Bar, MD, Co-principal investigator of the trial and associate professor of Medicine, Infectious Diseases, Hospital of the University of Pennsylvania. “These data pave the way for the use of REGEN-COV before patients become symptomatic, with more convenient subcutaneous administration.”
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Regeneron Pharmaceuticals, Inc.
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