Clinical trial NCT04709328: To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: COVID-19
SARS-CoV-2
Lead sponsor: Sinocelltech Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-14
Enrollment: 690
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Day 29
Secondary outcomes:
measure: Time to sustained resolution of all COVID-19-related symptoms
timeFrame: Day 29
measure: - Change in symptom score (total of ratings)
timeFrame: Day 3, 5, 7, 11, 15, 22, and 29
measure: Time to symptom improvement;
timeFrame: Day 29
measure: Proportion of participants admitted to hospital due to COVID-19
timeFrame: Day 29
measure: Proportion of participants with ≥1 COVID-19 related hospitalization
timeFrame: Day 29
measure: Proportion of participants with ≥2 COVID-19 related hospitalizations
timeFrame: Day 29
measure: Total number of COVID-19 related hospitalization
timeFrame: Day 29
measure: Proportion of participants who experience COVID-19 related emergency room (ER) visit
timeFrame: Day 29
measure: Proportion of participants with ≥1 ER visit due to COVID-19
timeFrame: Day 29
measure: Proportion of participants with ≥2 ER visits due to COVID-19 through Day 29
timeFrame: Day 29
measure: Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19
timeFrame: Day 29
measure: Proportion of patients with all-cause mortality
timeFrame: Day 29
measure: Proportion of participants with O2 requirement
timeFrame: Day 29
measure: Proportion of participants with ventilation requirements
timeFrame: Day 29
measure: Proportion of participants that achieve SARS-CoV-2 clearance in nasopharyngeal (NP) or oropharyngeal (OP) samples
timeFrame: Day 8, Day 15
measure: 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.
timeFrame: Day 8, Day 15
measure: Cumulative incidence of serious adverse events (SAEs)
timeFrame: Day 120
measure: Cumulative incidence of Grade 1, 2, 3 and 4 adverse events (AEs)
timeFrame: Day 120
measure: Discontinuation or temporary suspension of infusions (for any reason)
timeFrame: Day 120
measure: Number and proportion of patients with ADE
timeFrame: Day 120
measure: Mean concentration-time profiles of SCTA01
timeFrame: Day 29
measure: Incidence and titers (if applicable) of anti-drug antibodies (ADA) to SCTA01
timeFrame: Day 1, Day 8, Day 29, and Day 120)
Other outcomes:
Locations:
Study officials:
References:
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.