COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04709328

Qiang Guo, PhD

qiang_guo@sinocelltech.com

2021-01-14

Not recruiting

RCT

Randomized

Adaptive

Blind label

multi-center

Treatment

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.

- 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.

4

Sinocelltech Ltd.

18

100

None

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

690

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.

None

Phase 2/Phase 3

[{"arm_notes": "low dose", "treatment_id": 1175, "treatment_name": "Scta01", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "middle dose", "treatment_id": 1175, "treatment_name": "Scta01", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "High dose", "treatment_id": 1175, "treatment_name": "Scta01", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]