COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCTs041190120

Masashi Kondo

mkond@fujita-hu.ac.jp

2020-03-02

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

(1) Age 16 or greater at the time of consent(2) Sex, male or female(3) Outpatient or inpatient: inpatient (4) Meets all of 1), 2), 3) below 1)Has at least one RT-PCR test positive for SARS-CoV2 from pharyngeal or nasopharyngeal swab (date of collection must be within 14 days before enrollment) 2) Has a performance status of 0 or 1 3) Is able to remain inpatient for 6 days(5) Has a negative pregnancy test if the subject is female and pre-menopausal (6) Has provided written consent for participation, written consents from both the subject and a legal guardian

(1) Performance status of 2 or greater(2) Advanced liver function abnormalities classified as grade C by the Child-Pugh criteria(3) End-stage renal disease requiring dialysis(4) Altered mental status(5) Pregnant or planning pregnancy(6) If female, not agreeable to using oral contraceptive, intrauterine contraceptive device, mechanical contraceptive methods such as pessaries and condoms, or combinations thereof, during favipiravir administration and 90 days thereafter(7) If male, has a female partner who is not agreeable to the contraceptive methods described in (7) (8) If male, not agreeable to using condoms during favipiravir administration and 90 days thereafter(9) History of hereditary xanthine oxidase deficiency(10) History of hypouricemia (less than 1 mg/dL) or xanthine urolithiasis(11) History of uncontrolled gout or hyperuricemia (12) History of immunocompromising conditions such as HIV positivity(13) Has received systemic agents with suggested activity against SARS-CoV2 within 28 days before enrollment(14) Deemed ineligible as determined by the principal investigator or a co-investigator

2

Doi Yohei

16

None

Japan

Mild disease at enrollment

1: Mild disease at enrollment

86

Proportion of subjects with clearance of SARS-CoV2 in nasopharyngeal swab by Day 6

Phase 2

[{"arm_notes": "Immediate start", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Delayed start", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]