The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlledPhase II/III clinical trial. It will be conducted at selected investigational sitesglobally. 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.
Drug: SCTA01
Diluted by 0.9% normal saline，IV
Other: Placebo
IV
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.
Qiang Guo, PhD
86-10-5862 8288
qiang_guo@sinocelltech.com
Zhanghua Lan, PhD