FLARE: Favipiravir +/- Lopinavir: A RCT of Early Antivirals
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
The current pandemic of SARS-CoV-2 causing COVID-19 disease is an unprecedented global
emergency. COVID-19 appears to be a disease with an early phase where the virus replicates,
coinciding with first presentation of symptoms, followed by a later 'inflammatory' phase
which results in severe disease in some individuals. It is known from other rapidly
progressive infections such as sepsis and influenza that early treatment with antimicrobials
is associated with better outcome. Antiviral medications are most likely to be effective when
administered soon after infection. There is therefore an urgent need to study subjects who
have recently developed symptoms, or have recently been tested positive with or without
symptoms, and who can be sampled frequently to understand changes in viral load. This cohort
will allow us to collect detailed trajectory data on early disease and understand how
pharmacological interventions may affect this. The objective of the FLARE trial is to assess
whether early antiviral therapy with either favipiravir + Lopinavir/ritonavir (LPV/r), LPV/r
or favipiravir is associated with a decrease in viral load compared with placebo. The
hypothesis is that this holds for COVID-19 and that early antiviral treatment may prevent
progression to the later phase of the disease.