Analysis of the first 275 patients in a trial of the REGN-COV2 antibody cocktail showing reductions in viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. Greatest improvements were seen with patients that had not mounted their own effective immune response prior to treatment.
The mean time-weighted-average change from baseline nasopharyngeal viral load through Day 7 in the seronegative (no measurable antiviral antibodies) group was a 0.60 log10 copies/mL greater reduction (
p=0.03) in patients treated with high dose, and a 0.51 log10 copies/mL greater reduction (
p=0.06) in patients treated with low dose, compared to placebo. In the overall population, there was a 0.51 log10 copies/mL greater reduction (
p=0.0049) in patients treated with high dose, and a 0.23 log10 copies/mL greater reduction (
p=0.20) in patients treated with low dose, compared to placebo.
Among seronegative patients, median time to symptom alleviation (defined as symptoms becoming mild or absent) was 13 days in placebo, 8 days in high dose (
p=0.22), and 6 days in low dose (
p=0.09).
Adverse reactions were similar with treatment and placebo. There were no deaths.
Regeneron et al., 9/29/2020, Randomized Controlled Trial, USA, North America, preprint, 1 author.
recovery time, 38.0% lower, relative time 0.62, p = 0.22, treatment 92, control 91, high dose median time to recovery, group sizes estimated because they were not supplied.
recovery time, 54.0% lower, relative time 0.46, p = 0.09, treatment 92, control 91, low dose median time to recovery, group sizes estimated because they were not supplied.
Effect extraction follows
pre-specified rules
prioritizing more serious outcomes. For an individual study the most serious
outcome may have a smaller number of events and lower statistical signficance,
however this provides the strongest evidence for the most serious outcomes
when combining the results of many trials.