Favipiravir Therapy in Adults With Mild COVID-19 (Avi-Mild)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Favipiravir, COVID19, Mild illness, Saudi Arabia
Eligibility Criteria
Inclusion Criteria
Patients must be eligible according to the following criteria for enrollment
- Should be at least 18 years of age
- Male or non-pregnant female (pregnancy testing is not mandatory. If the patient requests or is not sure, the study team will provide it)
- Diagnosed with mild COVID-19* confirmed by positive PCR test for SARS-CoV-2 at the time of recruitment, a result within the last five days
- Patients have to be enrolled within 5 days of disease onset.
Exclusion criteria
Patients meeting any of the following criteria will be excluded from trial enrolment:
- Patients with concomitant documented bacterial pneumonia established through positive sputum cultures
- Patients who are pregnant or breastfeeding
- Known sensitivity/allergy to Favipiravir (If Faviparavir was used for COVID-19 in the patient previously for influenza)
Major comorbidities increasing the risk of study drug including
- Hematologic malignancy
- Advanced (stage 4-5) chronic kidney disease or dialysis therapy
- Severe liver damage (Child-Pugh score C, AST> 5 times the upper limit)
- HIV
- Gout/history of Gout or hyperuricemia (two times above the ULN)
(6) Having used Favipiravir or participated in any other interventional drug clinical study within 30 days before the first dose of study drug (i.e., the patient received it for influenza previously) (7) The investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues) (8) Clinical prognostic non-survival, palliative care, or in a deep coma and have no response to supportive treatment within three hours of admission.
(9) Hospitalized patients for mild, moderate, or severe COVID-19
Sites / Locations
- Prince Mohammed Bin Abdul Aziz Hospital - Al Madinah
- King Fahad Hospital - Madinah
- Primary Health Care-Safiyah
- King Abdullah Medical City - Makkah
- King Abdulaziz Medical City - Riyadh
- Primary Health Care-Al Mansoura
- Primary Health Care-Al Urijah
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Favipiravir
Placebo
Favipiravir: 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (Maximum days of therapy is 7 days)
9 tablets by mouth twice daily for one day, followed by 4 tablets twice daily (Maximum days of therapy is 7 days).