Status:
NOT_YET_RECRUITING
To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19
Lead Sponsor:
Sinocelltech Ltd.
Conditions:
COVID-19
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 compr...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
690 Patients enrolled
Trial Details
Trial ID
NCT04709328
Start Date
March 28 2021
End Date
March 1 2022
Last Update
March 29 2021
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