Status:
UNKNOWN
Efficacy of Favipiravir in Treatment of Mild & Moderate COVID-19 Infection in Nepal
Lead Sponsor:
Nepal Health Research Council
Conditions:
Covid19
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
COVID-19 has affected almost all countries in the world. Every other country is constantly working towards its treatment and development of vaccines, with little to no success so far. Recently, severa...
Detailed Description
COVID-19 stands for 2019 novel coronavirus or 2019-nCoV which is a new virus linked to the same family of viruses as Severe Acute Respiratory Syndrome (SARS), \& hence named as SARS-CoV-2. It has been...
Eligibility Criteria
Inclusion
- A.
- 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
- 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)
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2021
Estimated Enrollment :
676 Patients enrolled
Trial Details
Trial ID
NCT04694612
Start Date
January 1 2021
End Date
May 31 2021
Last Update
January 5 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Armed Police Force Hospital
Kathmandu, Bagmati, Nepal, 44600
2
Charak Memorial Hospital
Pokhara, Gandaki, Nepal, 33800