COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04373733

Pallav Shah

Research Delivery Operations Manager, research.development@chewest.nhs.uk (PI email not reported)

2020-05-04

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: adult participants: signed informed consent new admission to hospital for period expected to last ≥ 1 night suspected or confirmed covid-19 infection patients are suspected of covid-19 infection if they have the following: · influenza like illness (fever ≥37.8°c and at least one of the following respiratory symptoms, which must be of acute onset: persistent cough, hoarseness, nasal discharge or congestion, shortness of breath, sore throat, wheezing or sneezing). and · finding from either a chest x-ray or ct suggestive of covid-19 infection and · alternative causes are considered unlikely for women to be eligible to enter and participate in the study they should be: of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, or of child-bearing potential have a negative pregnancy test at screening and agrees to remain sexually abstinent or use a method of contraception with a failure rate of < 1% per year as indicated in appendix b during the treatment and for a period of 7 days after the last dose. hormonal contraceptive methods must be supplemented by a barrier method. men who are sexually active must use an adequate method of contraception as listed in appendix b, for a period of at least 7 days after the last dose

pregnant or breast feeding, due to potential teratogenicity hepatic impairment - (ast or alt > 3.5 x upper limit of normal) presently enrolled in an interventional drug study unable to take medication via the oral or nasogastric route known sensitivity favipiravir

3

Chelsea and Westminster NHS Foundation Trust

18

None

Brazil;Mexico;United Kingdom

Moderate disease at enrollment

3: Moderate disease at enrollment

502

Time from randomisation to a sustained clinical improvement (maintained for 24 hours) by two points on a seven-category ordinal scale or to discharge, whichever occurs first

None

Phase 3

[{"arm_notes": "", "treatment_id": 1543, "treatment_name": "Azithromycin+hydroxychloroquine+zinc", "treatment_type": "Antibiotics+antimalarials+vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]