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

Covid19 Clinical Trial

Official title:

A Multicenter, Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial to Evaluate the Efficacy and Safety of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in Hospitalized Patients With Severe COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04644185
• Other study ID #: SCTA01-B301
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 27, 2021
• Est. completion date: December 27, 2021

Study information

• Verified date: April 2021
• Source: Sinocelltech Ltd.
• Contact: Ji Qi, PhD
• Phone: +86-10-5862 8288
• Email: ji_qi[@]sinocelltech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 795
• Est. completion date: December 27, 2021
• Est. primary completion date: June 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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]}.

Related Conditions & MeSH terms

• Covid19

Intervention

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

Other:
• Placebo
all SCTA01 excipients without active component+best supportive care

Locations

Country	Name	City	State
Argentina	SCT study site	Ciudad Autonoma de Buenos aires
Brazil	SCT study site	Uberlândia
Chile	SCT study site	Talca
Colombia	SCT study site	Rionegro
Mexico	SCT study site	Monterrey
Peru	SCT study site	Lima
United States	SCT study site	Somers Point	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sinocelltech Ltd.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clinical efficacy of SCTA01 (Phase II and III)	As assessed by time to clinical improvement (TTCI)	Day 29
Secondary	Cumulative incidence of SAEs(Phase II, III)	Cumulative incidence of serious adverse events in both Phase II and III	3 Months
Secondary	Change from baseline in viral shedding as measured by RT-qPCR(Phase II and III)	Change from baseline in viral shedding as measured by RT-qPCR in NP swab samples	Day 120
Secondary	area under the curve (AUC0-t)(Phase II)	AUC0-t through Day 120	Day 120
Secondary	AUC0-8(Phase II)	AUC0-8 through Day 120	Day 120
Secondary	Half-life time (t1/2)(Phase II)	t1/2 through Day 120	Day 120
Secondary	Maximum concentration (Cmax)(Phase II)	Cmax through Day 120	Day 120
Secondary	Peak time (Tmax)(Phase II)	Tmax through Day 120	Day 120
Secondary	Clearance (CL)(Phase II)	CL through Day 120	Day 120
Secondary	Apparent volume of distribution (Vd)(Phase II)	Vd through Day 120	Day 120
Secondary	Elimination rate constant (?z)(Phase II)	?z through Day 120	Day 120
Secondary	Immunogenicity as measured by anti-drug antibodies (ADA) (Phase II, III)	ADA against SCTA01 at baseline and Day 120	Day 120