COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05620160

Not reported

Not reported

2022-11-17

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: participants who provide written informed consent before the trial, and fully understand the trial content, process and possible adverse reactions. participants who are willing and able to comply with the protocol for treatment plan, virological testing, laboratory testing and other study procedures. male or female participants aged 18-75 (including 18 and 75 years old). confirmed sars-cov-2 infection 120 hours prior to randomization. initial onset of covid-19 symptoms/signs within 48 hours before randomization. fertile participants must agree to take effective contraceptive measures.

patients with severe or critical covid-19 who currently require hospitalization, or patients who are expected to develop into severe or critical disease and require hospitalization within 48h after randomization. difficulty swallowing or a history of gastrointestinal diseases that seriously affect drug absorption. active liver disease, or obvious abnormal liver function (alt or ast ≥ 3uln, or total bilirubin ≥ 2uln). wbc >1uln, or neu <0.5ⅹ109/l. receiving dialysis or have known moderate to severe renal impairment (egfr<60ml/min/1.73m2). other suspected or confirmed systemic infections. current or expected use of strong cyp3a4 inducers, inhibitors or medications that are highly dependent on cyp3a4 or cyp2c19 for clearance. prior or anticipated receipt of any vaccine within 28 days prior to enrollment and during study period. use of antivirals against sars-cov-2 within 7 days prior to enrollment. weight≤40kg. pregnant, lactating women or those with a positive pregnancy test (sterilized or postmenopausal women may not have a pregnancy test). previous administration with any investigational drug within 3 months before the study drug administration. participants who are judged by the investigator to be unsuitable to participate in this study.

2

Guangdong Raynovent Biotech Co., Ltd

18

75

China

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

1359

Time to sustained clinical recovery of 11 COVID-19 symptoms

None

Phase 3

[{"arm_notes": "nan", "treatment_id": 2651, "treatment_name": "Ray1216", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]