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

• Status: Recruiting
• Trial end date: 2021-12-27
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sinocelltech Ltd.
• Treatments: Myeloma Proteins; Paraproteins

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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]}.