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

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sinocelltech Ltd.

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.