Sumary of REGEN-COV is effective in preventing severe COVID-19 in immunocompromised individuals:
- Immunocompromised individuals, particularly those with B-cell deficiencies or who are currently taking immunosuppressive medications, are not capable of developing an adequate immune response to coronavirus disease 2019 (COVID-19) vaccination.
- A recent study posted on the medRxiv* preprint server assesses the efficacy of repeat monthly subcutaneous (SC) doses of REGEN-COV in SARS-CoV-2-negative adults who were healthy or had chronic medical conditions.
- Study: Repeat Subcutaneous Administration of REGEN-COV® in Adults is Well-Tolerated and Prevents the Occurrence of COVID-19. Image Credit: PHOTOCREO Michal Bednarek / Shutterstock.
- com About the study The current study was a Phase 1, double-blind, and placebo-controlled study that was executed at seven sites throughout the U.S. and constituted a baseline/screening period, a treatment period, and a follow-up period of up to seven days, 24 weeks, and 28 weeks, respectively.
- There were 705 and 235 subjects in the REGEN-COV and placebo groups, respectively.
- The rationale for enrolling the 940 subjects in the study was to obtain sufficient safety data to support multiple REGEN-COV dose administration.
- Eligible subjects were healthy adult volunteers between the ages of 18–90 years who were confirmed to be SARS-CoV-2 negative by central lab reverse transcription-polymerase chain reaction (RT-PCR) of nasopharyngeal swab before or within 72 hours of randomization.
- For the duration of the study, subjects who tested positive for SARS-CoV-2, elected to receive COVID-19 vaccination, or experienced an adverse event (AE) were excluded and moved to the follow-up stage.