Clinical trial: Efficacy of Favipiravir in Treatment of Mild & Moderate COVID-19 Infection in Nepal (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)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Entailment