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

Phase 2

Terminated

• Conditions: Covid19
• Interventions: Drug: SCTA01; Other: Placebo

• Registration Number: NCT04644185
• Lead Sponsor: Sinocelltech Ltd.

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-22
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-11-25
• Study Start: 2021-03-27
• Primary Completion: 2021-12-29
• Study Completion: 2022-02-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 103

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]}.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCTA01 High Dose+BSC	SCTA01	SCTA01in a higher dose+best supportive care
Placebo+BSC	Placebo	SCTA01 excipients+best supportive care
SCTA01 Low Dose+BSC	SCTA01	SCTA01in a lower dose+best supportive care

Primary Outcome Measures

Name	Time	Method
The clinical efficacy of SCTA01 (Phase II and III)	Day 29	As assessed by time to clinical improvement (TTCI)

Secondary Outcome Measures

Name	Time	Method
Apparent volume of distribution (Vd)(Phase II)	Day 120	Vd through Day 120
Change from baseline in viral shedding as measured by RT-qPCR(Phase II and III)	Day 120	Change from baseline in viral shedding as measured by RT-qPCR in NP swab samples
area under the curve (AUC0-t)(Phase II)	Day 120	AUC0-t through Day 120
AUC0-∞(Phase II)	Day 120	AUC0-∞ through Day 120
Half-life time (t1/2)(Phase II)	Day 120	t1/2 through Day 120
Maximum concentration (Cmax)(Phase II)	Day 120	Cmax through Day 120
Immunogenicity as measured by anti-drug antibodies (ADA) (Phase II, III)	Day 120	ADA against SCTA01 at baseline and Day 120
Peak time (Tmax)(Phase II)	Day 120	Tmax through Day 120
Clearance (CL)(Phase II)	Day 120	CL through Day 120
Elimination rate constant (λz)(Phase II)	Day 120	λz through Day 120
Cumulative incidence of SAEs(Phase II, III)	3 Months	Cumulative incidence of serious adverse events in both Phase II and III

Trial Locations

Locations (1)

SCT study site; 🇵🇪 Lima, Peru