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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат SCTA01
  Diluted by 0.9% normal saline，IV
• Другое Placebo
  IV

Первичные конечные точки

• 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. [Срок оценки: Day 29]

Вторичные конечные точки (12)

• Time to sustained resolution of all COVID-19-related symptoms [Срок оценки: Day 29]
• - Change in symptom score (total of ratings) [Срок оценки: Day 3, 5, 7, 11, 15, 22, and 29]
• Time to symptom improvement; [Срок оценки: Day 29]
• Proportion of participants admitted to hospital due to COVID-19 [Срок оценки: Day 29]
• Proportion of participants with ≥1 COVID-19 related hospitalization [Срок оценки: Day 29]
• Proportion of participants with ≥2 COVID-19 related hospitalizations [Срок оценки: Day 29]
• Total number of COVID-19 related hospitalization [Срок оценки: Day 29]
• Proportion of participants who experience COVID-19 related emergency room (ER) visit [Срок оценки: Day 29]
• Proportion of participants with ≥1 ER visit due to COVID-19 [Срок оценки: Day 29]
• Proportion of participants with ≥2 ER visits due to COVID-19 through Day 29 [Срок оценки: Day 29]
• Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19 [Срок оценки: Day 29]
• Proportion of patients with all-cause mortality [Срок оценки: Day 29]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Diaz J, Fonseca A, Yan L, Liu D, Xie L. Efficacy and safety of SARS-CoV-2 neutralizing antibody, SCTA01, in high-risk outpatients diagnosed with COVID-19: A Phase II clinical trial. Contemp Clin Trials Commun. 2025 May 17;45:101496. doi: 10.1016/j.conctc.2025.101496. eCollection 2025 Jun. PMID 40520909
• 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. PMID 34473343

Идентификаторы

NCT: NCT04709328 · SCTA01-A301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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