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

Sinocelltech

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

COVID-19

Treatments

Drug: SCTA01 and SCTA01C

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05156645

SCTA01/SCTA01C-A301

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;