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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Covid19

In brief

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).

Key facts

Study ID

NCT04644185

Run by

Sinocelltech Ltd.

People needed

102

Starts

2021-03-27

Expected to finish

2022-02-11

Last updated by the study team

2025-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hospitalized patients with severe COVID-19 (5 point on NIH 8-point ordinal scale).
• Male or female adult ≥18 years of age at time of enrollment;
• Biological samples (not limited to any specific type) collected within 72 hours before randomization is laboratory-confirmed as SARS-CoV-2 infection (PCR or antigen-based diagnostic tests);
• ≤ 10 days since symptoms of COVID-19 onset.

You may not qualify if…

• Patients who need non-invasive ventilation or high flow oxygen (i.e., 6 point on the 8-point ordinal scale);
• Patients with critical COVID-19;
• Patients with Severe COVID-19 who received convalescent plasma or COVID-19 vaccine, or anti-SARS-CoV-2 spike (S) protein targeted therapy;
• Alanine-amino transferase (ALT) or aspartate transaminase (AST) is 5 times higher than the upper limit of the normal value;
• Estimated glomerular filtration rate (eGFR) <30 mL/min or on dialysis {eGFR calculated by Cockcroft-Gault formula (Cockcroft DW, 1976), Male: CrCL (mL/min) = [(140 - age) × weight (kg)] × 1/ [SCr (mg/dL) × 72]; Female: CrCL (mL/min) = [(140 - age) × weight (kg)] × 0.85/ [SCr (mg/dL) × 72]}.

Where it is running

• SCT study site — Somers Point, New Jersey, United States
• SCT study site — Buenos Aires, Argentina
• SCT study site — Uberlândia, Brazil
• SCT study site — Talca, Chile
• SCT study site — Rionegro, Colombia
• SCT study site — Monterrey, Mexico
• SCT study site — Lima, Peru

Full record on ClinicalTrials.gov

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