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

Study Overview
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Brief Summary
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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).

Official Title
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An Adaptive Phase I/II/III Trial to Evaluate the Efficacy and Safety of Anti-SARS-CoV-2 Monoclonal Antibody Combination (SCTA01C and SCTA01) for Treatment of Outpatients With COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: SCTA01 and SCTA01C
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCTA01 and SCTA01C+SOC<br> | Drug: SCTA01 and SCTA01C<br>* Diluted by 0.9% normal saline<br>|
| Placebo Comparator: Placebo+SOC<br> | Drug: Placebo<br>* Diluted by 0.9% normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (Phase III) |  | Day 29 | 
| Proportion of patients with ≥Grade 3 treatment related adverse event (TRAE) up to Day 8 (Phase I/II) |  | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time to symptom improvement |  | Day 29 | 
| Proportion of participants that achieve SARS-CoV-2 clearance in NP or OP samples |  | Day 29 | 
| Immunogenicity assessment includes the number and percentage of patients who develop detectable anti drug antibody |  | Day 120 | 
| Mean concentration-time profiles of SCTA01 and SCTA01C |  | Day 120 |