A Study to Evaluate Efficacy and Safety of the Combination of SCTA01 & SCTA01C in Outpatients With COVID-19

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is comprised of two parts: safety evaluation part (Phase I/II) and the pivotal study (Phase III) to evaluate the efficacy and safety of the combination of SCTA01 & SCTA01C compared to placebo in addition to Standard of Care (SOC).

• Phase: Phase 1/Phase 2
• 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 ≤10 days before randomization;

• First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤5 days prior to start of the infusion;

Exclusion Criteria:

• 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;