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

Sinocelltech

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Covid19

Treatments: Drug: SCTA01; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04644185

SCTA01-B301

Details and patient eligibility

About

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).

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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]}.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

102 participants in 3 patient groups

SCTA01 Low Dose+BSC

Experimental group

Description:

SCTA01in a lower dose+best supportive care

Treatment:

Drug: SCTA01

SCTA01 High Dose+BSC

Experimental group

Description:

SCTA01in a higher dose+best supportive care

Treatment:

Drug: SCTA01

Placebo+BSC

Active Comparator group

Description:

SCTA01 excipients+best supportive care

Treatment:

Other: Placebo