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. 2025 May 17:45:101496.
doi: 10.1016/j.conctc.2025.101496. eCollection 2025 Jun.

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

Jorge Diaz  1 , Allex Fonseca  2   3 , Lixin Yan  4 , Dongfang Liu  4 , Liangzhi Xie  4   5   6
Affiliations

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

Jorge Diaz et al. Contemp Clin Trials Commun. .

Abstract

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 (p = 0.20) or symptom score reduction (p = 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).

Keywords: COVID-19; Neutralizing antibody; SARS-CoV-2.

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Conflict of interest statement

Sinocelltech Ltd. sponsored this work. Lixin Yan, Dongfang Liu, and Liangzhi Xie are employees of Sinocelltech Co., Ltd. and have stock ownership and/or potential stock option interests in the company. All authors declare no other conflicts of interest.

Figures

Fig. 1
Fig. 1
Patient enrollment and treatment allocation. a: included in the efficacy analysis and safety analysis.
Fig. 2
Fig. 2
Symptom scores from baseline to Day 29.
Fig. 3
Fig. 3
Time for symptom improvement.
Fig. 4
Fig. 4
Time to sustained symptom resolution.
Fig. 5
Fig. 5
Viral load from baseline to Day 29.
See this image and copyright information in PMC

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