Efficacy and safety of SARS-CoV-2 neutralizing antibody, SCTA01, in high-risk outpatients diagnosed with COVID-19: A Phase II clinical trial

Background/Objective: This study was a randomized, double-blinded, placebo-controlled Phase II trial conducted to evaluate the efficacy of neutralizing monoclonal antibody (SCTA01) in high-risk outpatients diagnosed with COVID-19. Methods: The primary endpoint was the proportion of patients who experienced COVID-19-related hospitalization (defined as at least 24 h of acute care) or death (all causes) by Day 29. Additionally, the incidence of adverse events was comparable between the SCTA01 group (23.8 %) and the placebo group (24.0 %). Notably, no treatment-related serious adverse events (SAEs) were reported. Conclusions: There was no significant difference in clinical outcome between SCTA01 and placebo in the treatment of high-risk outpatients diagnosed with COVID-19, and it was well tolerated. CLINICAL TRIAL: The trial was registered at ClinicalTrial.gov (NCT04709328).