This is an open label randomized controlled clinical trial which was designed to confirm the potential efficacy and safety of favipiravir in the management of patients with mild to moderate COVID-19 compared to best supportive care.
Favipiravir is an antiviral agent whose indication in Japan is currently for influenza infections. There were earlier reports from China suggesting its promising potential for benefit in the treatment of COVID-19. This is an open label randomized controlled clinical trial was designed to verify the potential efficacy and safety of favipiravir in the management of patients with mild to moderate COVID-19 compared to best supportive care. This study will look at the potential of using this repurposed oral agent in managing non-severe cases of COVID19. Consenting patients admitted to hospitals or isolation/quarantine facilities will be randomized at a 2:1 ratio to either favipiravir versus best supportive care. Patients will be examined daily and will have xray and nasopharyngeal swabs every 3-4 days for close monitoring.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
144
1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily Plus Standard of Care
Best supportive care includes Standard treatment included oral or intravenous rehydration, electrolyte correction, antipyretics, analgesics, antibiotics and antiemetic drugs \& the medication any patient is on due to any concomitant diseases.
Dr. Regina Berba
Manila, National Capital Region, Philippines
RECRUITINGTime from initiation of treatment to clinical improvement
The duration from start of treatment (Favipiravir + Standard of care compared to Standard of care) to clinical improvement and maintained for at least 48 hours. Criteria for clinical improvement include all three must be reached: Body temperature: axillary ≤37.4°C Oxygen saturation measured by pulse oximeter of \>96% without oxygen inhalation Chest imaging findings with changes showing improvement
Time frame: 4 to 28 days
Clinical effect of Favipiravir + Standard of Care compared to Standard of Care on patient status as measured by 7-point scale
Change in the study specific seven-point scale from initiation of treatment to end of treatment
Time frame: 4 to 14 days of therapy
Number of participants with conversion to negative level of SARS-COV2 viral genome
Number of participants with conversion to negative level of SARS-COV2 viral genome
Time frame: 4 to 14 days of therapy
Number of participants with Changes in NEWS (National Early Warning Score)
Number of participants with Changes in NEWS (National Early Warning Score)
Time frame: 4 to 14 days of therapy
Number of participants with improvement in chest imaging findings
Number of participants with improvement in chest imaging findings
Time frame: 4 to 14 days of therapy
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