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

Purpose

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).

Condition

  • Covid19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SCTA01 Low Dose+BSC 		SCTA01in a lower dose+best supportive care
  • Drug: SCTA01
    SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
    Other names:
    • Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Experimental
SCTA01 High Dose+BSC 		SCTA01in a higher dose+best supportive care
  • Drug: SCTA01
    SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
    Other names:
    • Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Active Comparator
Placebo+BSC 		SCTA01 excipients+best supportive care
  • Other: Placebo
    all SCTA01 excipients without active component+best supportive care
    Other names:
    • SCTA01 excipients

Recruiting Locations

SCT study site
Somers Point, New Jersey 08244
Contact:
Lucasti

More Details

NCT ID
NCT04644185
Status
Unknown status
Sponsor
Sinocelltech Ltd.

Study Contact

Ji Qi, PhD
+86-10-5862 8288
ji_qi@sinocelltech.com

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.