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

NCT04644185 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-10-24

Study results available
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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).

Conditions

  • Covid19

Interventions

DRUG

SCTA01

SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody

OTHER

Placebo

all SCTA01 excipients without active component+best supportive care

Sponsors & Collaborators

  • Sinocelltech Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhanghua Lan, PhD · Sinocelltech Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-27
Primary Completion
2021-12-29
Completion
2022-02-11
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Chile
  • Colombia
  • Mexico
  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04644185 on ClinicalTrials.gov