To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19

NCT ID: NCT04709328

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 690 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-28
• Study Completion Date: 2022-03-01

Brief Summary

The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III clinical trial. It will be conducted at selected investigational sites globally. The study is comprised of 2 parts.

Detailed Description

The study is a multicenter, adaptive, randomized, double-blinded, and placebocontrolled Phase II/III trial. It will be conducted globally. The study will evaluate the efficacy and safety of SCTA01 in high-risk outpatients with COVID-19.The primary objective of the study is to evaluate the clinical efficacy rate among study group [SCTA01+ standard of care (SOC)] and control group (placebo + SOC) up to Day 29.

Conditions

COVID-19; SARS-CoV-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SCTA01 low dose +SOC

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

Group Type: EXPERIMENTAL

SCTA01

Intervention Type: DRUG

Diluted by 0.9% normal saline，IV

SCTA01 middle dose+SOC

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

Group Type: EXPERIMENTAL

SCTA01

Intervention Type: DRUG

Diluted by 0.9% normal saline，IV

SCTA01 High dose +SOC

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

Group Type: EXPERIMENTAL

SCTA01

Intervention Type: DRUG

Diluted by 0.9% normal saline，IV

Placebo+SOC

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

IV

Interventions

SCTA01

Diluted by 0.9% normal saline，IV

Intervention Type: DRUG

Placebo

IV

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or non-pregnant female adults, ≥18 years old of age at the time of randomization;
• Participants should have at least one of COVID-19 risk factor;
• Participants should have at least 2 COVID-19 related symptoms;
• Has symptoms consistent with COVID-19 as determined by the investigator with onset ≤7 days before randomization;
• First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤3 days prior to start of the infusion;
• Participants are currently not hospitalized;
• Participant (or legal authorized representative) has signed the ICF before any clinical activity related to SCTA01 trial;
• Women with childbearing potential must agree to use effective contraceptive methods during the study period;
• Patient should not participate in other clinical studies related to COVID-19 or SARS-CoV-2 infection.

Exclusion Criteria

• Have known allergies to any of the components used in the formulation of the SCTA01/placebo;
• Participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema;
• Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (FDA);
• Require mechanical ventilation or anticipated impending need for mechanical ventilation;
• Suspected or proven serious bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking part in this study;
• Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;
• Have any co-morbidity requiring surgery within <29 days, or that is considered life threatening within 29 days;
• Have a history of previous SARS-CoV-2 infection;
• Received convalescent plasma, COVID-19 vaccine, or anti-SARS-CoV-2 spike(S) protein targeted therapy;
• Have participated in a clinical study involving an investigational intervention within past 30 days or 5-half lives of investigational product, whichever is longer;
• Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing;
• Pregnant or lactating women;
• Anticipated hospitalization or transfer to another medical site which is not a study site within 72 hours;
• Participants unable to follow the protocol during the study;
• Participants deemed inappropriate for enrollment by the investigator due to other factors.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinocelltech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Qiang Guo, PhD

Role: CONTACT

qiang_guo@sinocelltech.com

86-10-5862 8288

Zhanghua Lan, PhD

Role: CONTACT

References

Diaz J, Fonseca A, Yan L, Liu D, Xie L. Efficacy and safety of SARS-CoV-2 neutralizing antibody, SCTA01, in high-risk outpatients diagnosed with COVID-19: A Phase II clinical trial. Contemp Clin Trials Commun. 2025 May 17;45:101496. doi: 10.1016/j.conctc.2025.101496. eCollection 2025 Jun.

Reference Type: DERIVED

PMID: 40520909 (View on PubMed)

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Reference Type: DERIVED

PMID: 34473343 (View on PubMed)

Other Identifiers

SCTA01-A301

Identifier Type: -

Identifier Source: org_study_id