A CDC investigation of a July 2019 COVID-19 outbreak in Massachusetts found breakthrough infections in fully vaccinated patients. The infections occurred in patients that had attend multiple large public gatherings that included travelers from many areas. This led the CDC to recommend that everyone wear masks, regardless of vaccination status, in indoor settings where there is a high risk of COVID-19 transmission.
In the 29-day, 1,505 patient, Phase III, PREVENTION trial (NCT04452318), symptomatic COVID-19 developed in 1.5% of patients that received a single subcutaneous injection of REGEN-COV (casirivimab and imdevimab) 1,200 mg compared to 7.8% of patients that received placebo in COVID-19 negative patients exposed to a COVID-19 positive patient in the same household. Among patients that became infected, treatment with REGEN-COV resulted in resolution of symptoms two-weeks earlier.
The FDA updated the EUA for Regeneron’s monoclonal antibody REGEN-COV to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination.
Lilly announced that in a sub-study of 101 COVID-19 patients that required mechanical ventilation or ECMO from the 1,525 patient, Phase III, COV-BARRIER trial (NCT04421027), mortality was 39.2% with baricitinib compared to 58% with placebo at 28 days and 45.1% vs 62% at day 60.
The FDA expanded the emergency use authorization for baricitinib to allow the drug to be used alone for the treatment of patients aged 2 years and older who are hospitalized with COVID-19 and require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation. Previously, baricitinib had to be administered with remdesivir when treating COVID-19.
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