Monitoring of COVID-19 cases
laboratory-confirmed SARS-CoV-2 infections
ASYMPTOMATIC COVID-19, DISEASE, SARS-COV-2 INFECTION
To specifically measure the incidence of laboratory-confirmed symptomatic COVID-19 post-administration, study sites contacted participants daily to collect nasopharyngeal/throat/nasal swab and monitor information on symptoms of COVID-19. The case monitoring period extended from 24 h after the first administration to 24 h after the last administration of SA58 or placebo, during which participants were observed closely. If a participant had positive RT–PCR testing result, he/she was defined a SARS-CoV-2 RT–PCR positive participant (e.g. laboratory-confirmed SARS-CoV-2 infection). And if a SARS-CoV-2 RT–PCR positive participant had symptoms of COVID-19 (Supplementary Table 1), this was defined as a laboratory-confirmed symptomatic COVID-19 case. Both laboratory-confirmed SARS-CoV-2 infections and symptomatic COVID-19 cases were followed up to disease resolution, or up to negative RT–PCR tests on two consecutive days.