To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in High-Risk Outpatients With COVID-19 (MAOP3 Trial)

Conditions
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COVID-19, SARS-CoV-2

Intervention / Treatment
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* Drug: SCTA01
* Other: 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 ≤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.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCTA01 low dose +SOC<br>SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody | Drug: SCTA01<br>* Diluted by 0.9% normal saline，IV<br>|
| Experimental: SCTA01 middle dose+SOC<br>SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody | Drug: SCTA01<br>* Diluted by 0.9% normal saline，IV<br>|
| Experimental: SCTA01 High dose +SOC<br>SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody | Drug: SCTA01<br>* Diluted by 0.9% normal saline，IV<br>|
| Placebo Comparator: Placebo+SOC<br>SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody | Other: Placebo<br>* IV<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. |  | Day 29 | 

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 admitted to hospital due to COVID-19 |  | Day 29 | 
| Proportion of participants with ≥1 COVID-19 related hospitalization |  | 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 who experience COVID-19 related emergency room (ER) visit |  | Day 29 | 
| 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 patients with all-cause mortality |  | Day 29 | 
| Proportion of participants with O2 requirement |  | Day 29 | 
| Proportion of participants with ventilation requirements |  | Day 29 | 
| Proportion of participants that achieve SARS-CoV-2 clearance in nasopharyngeal (NP) or oropharyngeal (OP) samples |  | Day 8, Day 15 | 
| 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 | 
| Cumulative incidence of serious adverse events (SAEs) |  | Day 120 | 
| Cumulative incidence of Grade 1, 2, 3 and 4 adverse events (AEs) |  | Day 120 | 
| Discontinuation or temporary suspension of infusions (for any reason) |  | Day 120 | 
| Number and proportion of patients with ADE |  | Day 120 | 
| Mean concentration-time profiles of SCTA01 |  | Day 29 | 
| Incidence and titers (if applicable) of anti-drug antibodies (ADA) to SCTA01 |  | Day 1, Day 8, Day 29, and Day 120) |