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

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ClinicalTrials.gov Identifier: NCT04644185
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Sinocelltech Ltd.

Tracking Information
First Submitted Date  ICMJE November 22, 2020
First Posted Date  ICMJE November 25, 2020
Last Update Posted Date April 12, 2021
Actual Study Start Date  ICMJE March 27, 2021
Estimated Primary Completion Date June 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2020)
The clinical efficacy of SCTA01 (Phase II and III) [ Time Frame: Day 29 ]
As assessed by time to clinical improvement (TTCI)
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2020)
  • The virologic efficacy of SCTA01 (Phase II) [ Time Frame: Day 8 ]
    As measured by RT-qPCR
  • The clinical efficacy of SCTA01 (Phase III) [ Time Frame: Day 29 ]
    As assessed by time to clinical improvement (TTCI)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2020)
  • Cumulative incidence of SAEs(Phase II, III) [ Time Frame: 3 Months ]
    Cumulative incidence of serious adverse events in both Phase II and III
  • Change from baseline in viral shedding as measured by RT-qPCR(Phase II and III) [ Time Frame: 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) [ Time Frame: Day 120 ]
    AUC0-t through Day 120
  • AUC0-∞(Phase II) [ Time Frame: Day 120 ]
    AUC0-∞ through Day 120
  • Half-life time (t1/2)(Phase II) [ Time Frame: Day 120 ]
    t1/2 through Day 120
  • Maximum concentration (Cmax)(Phase II) [ Time Frame: Day 120 ]
    Cmax through Day 120
  • Peak time (Tmax)(Phase II) [ Time Frame: Day 120 ]
    Tmax through Day 120
  • Clearance (CL)(Phase II) [ Time Frame: Day 120 ]
    CL through Day 120
  • Apparent volume of distribution (Vd)(Phase II) [ Time Frame: Day 120 ]
    Vd through Day 120
  • Elimination rate constant (λz)(Phase II) [ Time Frame: Day 120 ]
    λz through Day 120
  • Immunogenicity as measured by anti-drug antibodies (ADA) (Phase II, III) [ Time Frame: Day 120 ]
    ADA against SCTA01 at baseline and Day 120
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2020)
  • Clinical efficacy of SCTA01(Phase II) [ Time Frame: Day 29 ]
    TTCI
  • Cumulative incidence of SAEs(Phase II, III) [ Time Frame: 3 Months ]
    Cumulative incidence of serious adverse events in both Phase II and III
  • Change from baseline in viral shedding as measured by RT-qPCR(Phase III) [ Time Frame: Day 85 ]
    Change from baseline in viral shedding as measured by RT-qPCR in in NP swab samples
  • area under the curve (AUC0-t)(Phase II) [ Time Frame: Day 85 ]
    AUC0-t through Day 85
  • AUC0-∞(Phase II) [ Time Frame: Day 85 ]
    AUC0-∞ through Day 85
  • Half-life time (t1/2)(Phase II) [ Time Frame: Day 85 ]
    t1/2 through Day 85
  • Maximum concentration (Cmax)(Phase II) [ Time Frame: Day 85 ]
    Cmax through Day 85
  • Peak time (Tmax)(Phase II) [ Time Frame: Day 85 ]
    Tmax through Day 85
  • Clearance (CL)(Phase II) [ Time Frame: Day 85 ]
    CL through Day 85
  • Apparent volume of distribution (Vd)(Phase II) [ Time Frame: Day 85 ]
    Vd through Day 85
  • Elimination rate constant (λz)(Phase II) [ Time Frame: Day 85 ]
    λz through Day 85
  • Immunogenicity as measured by anti-drug antibodies (ADA) (Phase II, III) [ Time Frame: Day 29 ]
    ADA against SCTA01 at baseline and Day 29
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: SCTA01
    SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
    Other Name: Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
  • Other: Placebo
    all SCTA01 excipients without active component+best supportive care
    Other Name: SCTA01 excipients
Study Arms  ICMJE
  • Experimental: SCTA01 Low Dose+BSC
    SCTA01in a lower dose+best supportive care
    Intervention: Drug: SCTA01
  • Experimental: SCTA01 High Dose+BSC
    SCTA01in a higher dose+best supportive care
    Intervention: Drug: SCTA01
  • Active Comparator: Placebo+BSC
    SCTA01 excipients+best supportive care
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 24, 2020)
795
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 27, 2021
Estimated Primary Completion Date June 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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]}.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ji Qi, PhD +86-10-5862 8288 ext 9360 ji_qi@sinocelltech.com
Listed Location Countries  ICMJE Argentina,   Brazil,   Chile,   Colombia,   Mexico,   Peru,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04644185
Other Study ID Numbers  ICMJE SCTA01-B301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sinocelltech Ltd.
Study Sponsor  ICMJE Sinocelltech Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Zhanghua Lan, PhD Sinocelltech Ltd.
PRS Account Sinocelltech Ltd.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP