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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
231
1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily
(9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days)
King Fahad Hospital - Madinah
Al Madīnah, Saudi Arabia
Primary Health Care-Safiyah
Al Madīnah, Saudi Arabia
Prince Mohammed Bin Abdul Aziz Hospital - Al Madinah
Al Madīnah, Saudi Arabia
King Abdullah Medical City - Makkah
Mecca, Saudi Arabia
PCR negative
Time from randomization to negativity in RT-PCR nucleic acid test for COVID-19 within 15 days of randomization
Time frame: 15 days
Time from randomization to clinical recovery
The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory symptoms, and relief of cough (or other relevant symptoms at enrollment) that is maintained for at least 72 hours.
Time frame: 15 days
Evaluate symptoms progression
Evaluate symptoms severity and the disease course progression in both arms till 28 days after starting the medicine.
Time frame: 28 days
Evaluate Faviparivirs effect
To evaluate Favipiravir's effect on the requirement of the use of antipyretics, analgesics, or antibiotics within 15 days after starting medicine.
Time frame: 15 days
Evaluate Favipiravir's effect
To evaluate Favipiravir's effect on disease complications within 28 days after starting medicine (hospitalization, ICU admission, or Mechanical ventilation )
Time frame: 28 days
Evaluate the safety of Favipiravir
Evaluate the safety of investigational drug compared to the control arm within 15 days after starting the medicine. This is assessed by allergic reactions, medication intolerance, liver toxicity, and hyperuricemia in subjects
Time frame: 28 days
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King Abdulaziz Medical City - Riyadh
Riyadh, Saudi Arabia
Primary Health Care-Al Mansoura
Riyadh, Saudi Arabia
Primary Health Care-Al Urijah
Riyadh, Saudi Arabia