COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05162365

Not reported

Not reported

2021-12-17

Terminated

RCT

Randomized

Factorial

Blind label

multi-center

Treatment

main inclusion criteria: first onset of covid-19 symptoms <7 days at randomization, symptoms such as fever and/or chills, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea. have a positive sars-cov-2 reverse transcription-polymerase chain reaction (rt-pcr) test using an appropriate sample such as nasopharyngeal (np), nasal, oropharyngeal, or saliva within 72 hours prior to randomization. a historical record of a positive result from a test conducted ≤72 hours prior to randomization is acceptable. male or female patients ≥18 years of age at the time of signing informed consent. agree to use an adequate method of contraception throughout the study period and for 90 days after the dose of study drug is administered. women of childbearing potential (wocbp) must have a negative urinary pregnancy test at screening. main

according to protocol v3.0, note: patients with mild-to-moderate disease who are placed in a facility where required by local guidelines can be enrolled. have oxygen saturation (spo2) ≤93 % on room air at sea level or a ratio of arterial oxygen partial pressure (pao2 in millimeters of mercury) to fractional inspired oxygen (fio2) <300, respiratory rate ≥30 per minute, heart rate ≥125 per minute. have evidence of multi-organ dysfunction/failure. systolic blood pressure <90 mmhg, diastolic blood pressure <60 mmhg, or requiring vasopressors. require or anticipated impending need for endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo).

2

Innovent Biologics (Suzhou) Co. Ltd.

18

100

United States

Mild disease at enrollment

1: Mild disease at enrollment

248

Number of treatment related AEs;Virologic efficacy Evaluation

None

Phase 1/Phase 2

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