To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19
- Registration Number
- NCT04709328
- Lead Sponsor
- Sinocelltech Ltd.
- 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 comprised of 2 parts.
- 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 high-risk outpatients with COVID-19.The primary objective of the study is to evaluate the clinical efficacy rate among study group \[SCTA01+ standard of care (SOC)\] and control group (placebo + SOC) up to Day 29.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 690
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SCTA01 low dose +SOC SCTA01 SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody SCTA01 middle dose+SOC SCTA01 SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody SCTA01 High dose +SOC SCTA01 SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody Placebo+SOC Placebo SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
- Primary Outcome Measures
Name Time Method Proportion of participants who experience COVID-19 related hospitalization (defined as at least 24 hours of acute care) or death (all cause) up to Day 29. Day 29
- Secondary Outcome Measures
Name Time Method Proportion of participants with ventilation requirements Day 29 Cumulative incidence of serious adverse events (SAEs) Day 120 Proportion of participants with ≥1 ER visit due to COVID-19 Day 29 Proportion of participants with ≥2 ER visits due to COVID-19 through Day 29 Day 29 Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19 Day 29 Proportion of participants with O2 requirement Day 29 Time to symptom improvement; Day 29 Proportion of participants with ≥1 COVID-19 related hospitalization Day 29 Proportion of participants who experience COVID-19 related emergency room (ER) visit Day 29 Proportion of patients with all-cause mortality Day 29 Discontinuation or temporary suspension of infusions (for any reason) Day 120 Incidence and titers (if applicable) of anti-drug antibodies (ADA) to SCTA01 Day 1, Day 8, Day 29, and Day 120) Time to sustained resolution of all COVID-19-related symptoms Day 29 - Change in symptom score (total of ratings) Day 3, 5, 7, 11, 15, 22, and 29 Proportion of participants admitted to hospital due to COVID-19 Day 29 Proportion of participants with ≥2 COVID-19 related hospitalizations Day 29 Total number of COVID-19 related hospitalization Day 29 Proportion of participants that achieve SARS-CoV-2 clearance in nasopharyngeal (NP) or oropharyngeal (OP) samples Day 8, Day 15 Cumulative incidence of Grade 1, 2, 3 and 4 adverse events (AEs) Day 120 Number and proportion of patients with ADE Day 120 Change from baseline (Day 1) to Day 8 or Day 15 in SARS-CoV-2 viral shedding as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in NP or OP samples for SARS-CoV-2 test. Day 8, Day 15 Mean concentration-time profiles of SCTA01 Day 29