To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSinocelltech Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- SCTA01
- Placebo
Treatment groups
690 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov