NCT04709328

To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19

An Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in High-Risk Outpatients With COVID-19 (MAOP3 Trial)

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 690 (estimated)
• 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 clinical trial. It will be conducted at selected investigational sites globally. The study is comprised of 2 parts.

Detailed description

The study is a multicenter, adaptive, randomized, double-blinded, and placebocontrolled Phase II/III trial. It will be conducted globally. The study will evaluate the efficacy and safety of SCTA01 in high-risk outpatients with COVID-19.The primary objective of the study is to evaluate the clinical efficacy rate among study group \[SCTA01+ standard of care (SOC)\] and control group (placebo + SOC) up to Day 29.

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
DRUG	SCTA01	Diluted by 0.9% normal saline，IV
OTHER	Placebo	IV

Timeline

• Start date: 2021-03-28
• Primary completion: 2022-01-01
• Completion: 2022-03-01
• First posted: 2021-01-14
• Last updated: 2021-03-29

Regulatory

• FDA-regulated drug study