to evaluate scta01 treatment of high-risk outpatients with covid-19

Conditions: COVID-19; SARS-CoV-2

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.

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.