NCT04644185

The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19

A Multicenter, Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial to Evaluate the Efficacy and Safety of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in Hospitalized Patients With Severe COVID-19

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III trial, and will be conducted globally. The study is comprised of two parts: dose selection (Phase II) and pivotal treatment effect (Phase III).

Detailed description

In this study, Phase II part will evaluate the efficacy, safety and PK of SCTA01 low dose+BSC, high dose+BSC and placebo+BSC in patients with severe COVID-19. In Phase II part, subjects will be randomized at 1:1:1 ratio. At the end of Phase II part, a dose for the Phase III will be determined. The Phase III part will evaluate the efficacy, safety, and immunogenicity of SCTA01 at the recommended dose recommended. Subjects in Phase III part will be randomized at 1:1 ratio to SCTA01+BSC and placebo+BSC groups.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	SCTA01	SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
OTHER	Placebo	all SCTA01 excipients without active component+best supportive care

Timeline

• Start date: 2021-03-27
• Primary completion: 2021-12-29
• Completion: 2022-02-11
• First posted: 2020-11-25
• Last updated: 2025-10-24
• Results posted: 2025-10-24

Locations

7 sites across 7 countries: United States, Argentina, Brazil, Chile, Colombia, Mexico, Peru

Regulatory

• FDA-regulated drug study