MAOP3: To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SCTA01 low dose +SOC SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody |
Drug: SCTA01
Diluted by 0.9% normal saline，IV
|
| Experimental: SCTA01 middle dose+SOC SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody |
Drug: SCTA01
Diluted by 0.9% normal saline，IV
|
| Experimental: SCTA01 High dose +SOC SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody |
Drug: SCTA01
Diluted by 0.9% normal saline，IV
|
| Placebo Comparator: Placebo+SOC SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody |
Other: Placebo
IV
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sinocelltech Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCTA01-A301