NCT05014373

Philippine Trial to Determine Efficacy and Safety of Favipiravir for COVID-19

An Investigation of the Efficacy and Safety of Favipiravir in Hospitalized NON- SEVERE COVID-19 Patients - An Open-label Randomized Controlled Multi Center Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: University of the Philippines · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Covid19

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Favipiravir + Standard of Care	1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily Plus Standard of Care
PROCEDURE	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.

Timeline

• Start date: 2020-10-12
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2021-08-20
• Last updated: 2021-08-20

Locations

1 site across 1 country: Philippines