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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.

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).

Condition or disease Intervention/treatment Phase
Covid19 Drug: SCTA01 Other: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 795 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 27, 2021
Estimated Primary Completion Date : June 27, 2021
Estimated Study Completion Date : December 27, 2021

Arm Intervention/treatment
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 Name: 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 Name: 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 Name: SCTA01 excipients




Primary Outcome Measures :
  1. The clinical efficacy of SCTA01 (Phase II and III) [ Time Frame: Day 29 ]
    As assessed by time to clinical improvement (TTCI)


Secondary Outcome Measures :
  1. Cumulative incidence of SAEs(Phase II, III) [ Time Frame: 3 Months ]
    Cumulative incidence of serious adverse events in both Phase II and III

  2. 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

  3. area under the curve (AUC0-t)(Phase II) [ Time Frame: Day 120 ]
    AUC0-t through Day 120

  4. AUC0-∞(Phase II) [ Time Frame: Day 120 ]
    AUC0-∞ through Day 120

  5. Half-life time (t1/2)(Phase II) [ Time Frame: Day 120 ]
    t1/2 through Day 120

  6. Maximum concentration (Cmax)(Phase II) [ Time Frame: Day 120 ]
    Cmax through Day 120

  7. Peak time (Tmax)(Phase II) [ Time Frame: Day 120 ]
    Tmax through Day 120

  8. Clearance (CL)(Phase II) [ Time Frame: Day 120 ]
    CL through Day 120

  9. Apparent volume of distribution (Vd)(Phase II) [ Time Frame: Day 120 ]
    Vd through Day 120

  10. Elimination rate constant (λz)(Phase II) [ Time Frame: Day 120 ]
    λz through Day 120

  11. Immunogenicity as measured by anti-drug antibodies (ADA) (Phase II, III) [ Time Frame: Day 120 ]
    ADA against SCTA01 at baseline and Day 120



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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]}.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04644185


Contacts
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Contact: Ji Qi, PhD +86-10-5862 8288 ext 9360 ji_qi@sinocelltech.com

Locations
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United States, New Jersey
SCT study site Recruiting
Somers Point, New Jersey, United States, 08244
Contact: Lucasti         
Argentina
SCT study site Not yet recruiting
Ciudad Autonoma de Buenos aires, Argentina
Contact: Marcelo         
Brazil
SCT study site Not yet recruiting
Uberlândia, Brazil
Contact: Arantes         
Chile
SCT study site Not yet recruiting
Talca, Chile
Contact: Silva         
Colombia
SCT study site Not yet recruiting
Rionegro, Colombia
Contact: Gomez         
Mexico
SCT study site Not yet recruiting
Monterrey, Mexico
Contact: Mercado Longoria         
Peru
SCT study site Not yet recruiting
Lima, Peru
Contact: Carbajal         
Sponsors and Collaborators
Sinocelltech Ltd.
Investigators
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Study Director: Zhanghua Lan, PhD Sinocelltech Ltd.
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Responsible Party: Sinocelltech Ltd.
ClinicalTrials.gov Identifier: NCT04644185    
Other Study ID Numbers: SCTA01-B301
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Myeloma Proteins
Paraproteins
Immunologic Factors
Physiological Effects of Drugs