Double blind RCT for mild-moderate COVID-19 outpatients in Israel showing significantly faster reduction in viral load with treatment, and zero hospitalizations with treatment compared with 2 for the control group.
There were no safety issues. Sheba IRB-7156/20. NCT04429711.
Schwartz et al., 2/12/2021, Double Blind Randomized Controlled Trial, Israel, Middle East, preprint, 1 author, dosage 12mg days 1-3, 15mg for patients >= 70kg.
risk of hospitalization, 80.7% lower, RR 0.19, p = 0.23, treatment 0 of 49 (0.0%), control 2 of 45 (4.4%).
risk of no virological cure, 51.4% lower, RR 0.49, p = 0.01, treatment 16 of 49 (32.7%), control 25 of 45 (55.6%), adjusted per study, odds ratio converted to relative risk, multivariable logistic regression, day 6, Ct>30.
risk of no virological cure, 54.1% lower, RR 0.46, p = 0.02, treatment 9 of 49 (18.4%), control 18 of 45 (40.0%), day 10, Ct>30.
risk of no virological cure, 54.1% lower, RR 0.46, p = 0.02, treatment 10 of 49 (20.4%), control 20 of 45 (44.4%), day 8, Ct>30.
risk of no virological cure, 41.2% lower, RR 0.59, p = 0.04, treatment 16 of 49 (32.7%), control 25 of 45 (55.6%), day 6, Ct>30.
risk of no virological cure, 37.9% lower, RR 0.62, p = 0.09, treatment 11 of 26 (42.3%), control 15 of 22 (68.2%), day 4, Ct>30.
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.