Efficacy of Favipiravir in Treatment of Mild & Moderate COVID-19 Infection in Nepal
Covid19
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
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. Exclusion Criteria:
- 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)
Sites / Locations
- Armed Police Force HospitalRecruiting
- Charak Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Mild condition
Moderate condition
Study arm groups will receive a Favipiravir treatment of 1800 mg po BID on day 1, then 800 mg po BID from day 2 onwards and control groups will receive the same quantity of Placebo. Duration of treatment : 5 days in each group
Study arm groups will receive a Favipiravir treatment of 1800 mg po BID on day 1, then 800 mg po BID from day 2 onwards and control groups will receive Inj Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily. Duration of treatment : 10 days in Favipiravir group & 5 days in Remdesivir group