COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04818320

Wenyao Mak

makwenyao@gmail.com

2021-03-26

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - patients are eligible to be included in the study only if they fulfil all the following criteria: - rt-pcr confirmed covid-19 cases - aged 50 years and above, and have one or more co-morbidities - within the first 7 days of illness (from symptom onset) - mild to moderate clinical severity

- asymptomatic stage 1 patients - patients with spo2 less than 95% without oxygen therapy - patients who needs oxygen supplements - patients with concomitant bacterial or fungal infection (confirmed by culture) prior to initiation of study - patients with congestive heart failure - patients with severe hepatic impairment (>grade 3: alt >10 times of upper normal limit) - impaired kidney function (creatinine clearance according to cockcroft-gault formula less than 30 ml/min) at the time of screening. - malabsorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others). - pregnant or nursing women or women planning pregnancy. - female patients who cannot consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices from the start of favipiravir administration to 7 days after the end of favipiravir administration - male patients whose partner cannot agree to use the contraception method described in (9) - patients with a history of gout or on treatment for gout or hyperuricemia - patients receiving immunosuppressants - patients who received interferon or drugs with reported antiviral activity against covid-19 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination) within 7 days of illness. - patients in whom this episode of infection is a recurrence or reinfection of covid-19 infection - patients who have previously received favipiravir - patients who are not able to provide written consent by themselves - other patients judged ineligible by the principal investigator or sub-investigator

2

Penang Hospital, Malaysia

50

100

Malaysia

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

500

Need for oxygen supplement

None

Phase 3

[{"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"}]