RESIST (Sputnik V Gamaleya Research Institute Russia), 2020 NCT04530396
Sputnik V (Gam-COVID-Vac) (n=16501) vs. placebo (n=5476)
randomized controlled trial
high risk of bias
Gam-COVID-Vac
(0ยท5 mL/dose) intramuscularly in a prime-boost regimen: a 21-day interval between the first dose (rAd26) and the second dose (rAd5), both vectors carrying the gene for the full-length SARS-CoV-2 glycoprotein S
placebo
2 doses IM (day 0 and day 21 /-2)
COVID-19 prophylaxis (excluding children)
double blind
25 hospitals and polyclinics in Moscow, Russia
interim analysis without adjustment of type 1 error rate