Favipiravir is a selective and potent inhibitor of influenza viral RNA polymerase. It acts as a purine analogue, which selectively inhibits viral RNA-dependent RNA polymerase (RdRps). It has the characteristic of acting on RNA viruses including Ebola and Coronaviruses especially novel coronavirus (2019-nCoV). The purpose of this study is to evaluate the clinical efficacy and safety of Favipiravir in comparison to placebo in the treatment of mild COVID-19 cases. It is a Multicenter, randomized double-blinded, parallel-group trial.
Drug: Favipiravir
1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily
Drug: Placebo
(9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days)
Inclusion Criteria
Patients must be eligible according to the following criteria for enrollment
1. Should be at least 18 years of age
2. Male or non-pregnant female (pregnancy testing is not mandatory. If the patient
requests or is not sure, the study team will provide it)
3. 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
4. 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:
1. Patients with concomitant documented bacterial pneumonia established through positive
sputum cultures
2. Patients who are pregnant or breastfeeding
3. Known sensitivity/allergy to Favipiravir (If Faviparavir was used for COVID-19 in the
patient previously for influenza)
4. 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
Prince Mohammed Bin Abdul Aziz Hospital - Al Madinah
Al Madinah, Saudi Arabia
King Fahad Hospital - Madinah
Al Madīnah, Saudi Arabia
Primary Health Care-Safiyah
Al Madīnah, Saudi Arabia
King Abdullah Medical City - Makkah
Mecca, Saudi Arabia
King Abdulaziz Medical City - Riyadh
Riyadh, Saudi Arabia
Primary Health Care-Al Mansoura
Riyadh, Saudi Arabia
Primary Health Care-Al Urijah
Riyadh, Saudi Arabia
Mohammad Bosaeed, Principal Investigator
KAMC-RD, Ministry of National Guard Health Affairs (MNGHA), Saudi Arabia