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

Phase 2

Not yet recruiting

• Conditions: SARS-CoV-2; COVID-19
• Interventions: Drug: SCTA01; Other: Placebo

• 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.

Study Timeline

• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-14
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Study Start: 2021-03-28
• Last Update Posted: 2021-03-29
• Primary Completion: 2022-01-01
• Study Completion: 2022-03-01

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 ≥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
Proportion of participants with ventilation requirements	Day 29
Cumulative incidence of serious adverse events (SAEs)	Day 120