COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04694612

Prabhat Adhikari, MD

prabhatadhikari@gmail.com

2021-01-05

Unknown

RCT

Randomized

Parallel

Open label

multi-center

Treatment

a. inclusion criteria: minimum 18 - 80 years of age clinical diagnosis of covid 19 with rt-pcr test for sars-cov-2 (if a patient is covid19 positive based on antigen test, they can participate in the trial while awaiting result form pcr test with ct-value) signed informed consent provided by patient's or patient's healthcare proxy. fulfills enrollment criteria ( within 6 days of symptoms onset) willing to practice celibacy or take contraception during the study & within 7 days after treatment mild clinical condition with at least 3 of these of these symptoms : fever, cough, malaise/headache moderate clinical condition with at least 3 of these of these symptoms : fever, cough, malaise/headache b.

pregnant (female of childbearing age with positive urine pregnancy test) or miscarriage or within 2 weeks after delivery severe or critical clinical condition as per nmc clinical guideline for covid19 chronic liver with alt/ast increased 5 times higher than the upper limit of normal or with child pugh c creatinine clearance (cockcroft-gault equation) < 30 ml/min or having hemodialysis/peritoneal dialysis known allergy or hypersensitivity to favipiravir gout or history of gout or hyperuricemia two times the upper limit of normal if using remdesivir, lopinavir-ritonavir, hydroxychloroquine or any other antiviral drug with potential effect against sars-cov-2 virus lactating female asymptomatic covid-19 cases mild covid-19 cases not meeting the inclusion criteria symptoms moderate covid-19 cases not meeting the inclusion criteria symptoms (*all female patients age 18 - 50 years will be screened for pregnancy by urine test & any pregnant patient will be excluded. also, the patient must be consented to take contraception or practice celibacy during the study period & until 7 days after treatment. since the expected wash out period of the study drug favipiravir is 10hrs minimum to 27.5hrs maximum (half life is 2-5.5hrs), it is a safe practice to avoid conception for 1 week after stopping the drug of interest)

2

Nepal Health Research Council

18

80

Nepal

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

676

clinical improvements in mild cases;clinical improvements in moderate cases

None

Phase 3

[{"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1516, "treatment_name": "Favipiravir+remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]