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: The neutralizing monoclonal antibody against SARS-CoV-2 is regarded as one of the most effective therapies for COVID-19. 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.

RESULTS

109 patients were randomly assigned to and received SCTA01 750 mg (n = 25), 1500 mg (n = 29), 3000 mg (n = 30), or placebo (n = 25). Only two experienced COVID-19-related hospitalization by Day 29, one from the 750 mg group and the other from the 3000 mg group. Statistical analysis revealed no significant differences in viral load reduction ( = 0.20) or symptom score reduction ( = 0.37) between the SCTA01 total and placebo groups. 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).