Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
NCT ID:
NCT04694612
Eligibility Criteria:
A. Inclusion Criteria:
1. Minimum 18 - 80 years of age
2. 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)
3. Signed informed consent provided by patient's or patient's healthcare proxy.
4. Fulfills enrollment criteria ( within 6 days of symptoms onset)
5. Willing to practice celibacy OR take contraception during the study \& within 7 days after treatment
6. Mild clinical condition with at least 3 of these of these symptoms : fever, cough, malaise/headache
7. Moderate clinical condition with at least 3 of these of these symptoms : fever, cough, malaise/headache
B. Exclusion Criteria:
1. Pregnant (female of childbearing age with positive urine pregnancy test) or miscarriage or within 2 weeks after delivery
2. 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
3. Creatinine clearance (Cockcroft-Gault Equation) \< 30 ml/min or having hemodialysis/peritoneal dialysis
4. Known allergy or hypersensitivity to Favipiravir
5. Gout or history of gout or hyperuricemia two times the upper limit of normal
6. If using Remdesivir, Lopinavir-ritonavir, Hydroxychloroquine or any other antiviral drug with potential effect against SARS-CoV-2 virus
7. Lactating female
8. Asymptomatic COVID-19 cases
9. Mild COVID-19 cases not meeting the inclusion criteria symptoms
10. 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04694612
Study Brief:
Protocol Section:
NCT04694612