FAMOVID: A randomized open-label trial to compare the efficacy and safety of favipiravir and molnupiravir in adults with mild to moderate COVID-19 and increased risk of disease severity

This research study is a collaboration between researchers and physicians and is supported by Thailand National Science and Technology Development Agency (NSTDA) and the Department of Medical Services at the Ministry of Public Health. 

About the Study:

COVID-19 is caused by an infection with the coronavirus SARS-CoV-2. It can cause respiratory symptoms of various intensity depending on the patient's health status and the strain (or variant) of the virus. In its most severe form, it can cause acute respiratory failure and death. It usually worsens by the second week of the infection. Studies have found that the lungs can be damaged by an inflammatory reaction triggered by the infection. When the lungs are damaged, the blood does not receive enough oxygen for the needs of the body.

Favipiravir has been used for COVID-19 since the beginning of the pandemic in Thailand and other countries. However, there are still discussions about the efficacy of this drug. Recently, another drug, molnupiravir, has shown some efficacy in patients with mild to moderate COVID-19. There has not been any study comparing the efficacy of favipiravir and molnupiravir. This study will clarify whether molnupiravir is more efficacious than favipiravir. 

Primary Objective:

To compare the risk of pulmonary involvement after starting treatment with favipiravir versus molnupiravir in adult patients with mild to moderate COVID-19 and increased risk of disease severity.

Secondary Objectives:

• To compare the risk of hospitalization related to COVID-19 between arms.
• To compare the risk of death between arms.
• To compare the occurrence of sustained clinical recovery between arms.
• To compare the risk of sustained viral shedding between arms.
• To compare the risk of adverse events between arms.

980 participants participated in this study enrolled in 10 sites in Thailand: Thammasat University Hospital, Chulabhorn Hospital, Ramadhibodi Chakri Naruebodindra Hospital, Siriraj Hospital, Rajavithi Hospital, Prince of Songkla University, Health Promotion Center Region 1 (Chiang Mai), Lampang Hospital, Samutsakhon Hospital, and Mahasarakham Hospital.

Sponsor: Thailand National Science and Technology Development Agency (NSTDA) 
and Department of Medical Services (DMS), Ministry of Public Health