- Orton CM, et al. A randomised controlled trial of early intervention with oral favipiravir in patients hospitalised with COVID-19 (PIONEER Trial). ALERT 3, RCT2882 ERS International Congress 2022, Barcelona, Spain, 4–6 September.
“Re-using existing agents for a different purpose is faster than developing novel drugs,” argued Dr Christopher Orton (Royal Brompton Hospital, UK). Following this rationale, the phase 3 PIONEER trial (NCT04373733) was designed to test favipiravir, a medicine that demonstrated activity against various RNA viruses, in individuals with COVID-19 (n=503). Patients who were hospitalised due to COVID-19 were randomised 1:1 to receive a 10-day treatment with favipiravir or placebo. The primary objective of the trial was to assess whether early intervention with favipiravir reduced the time to significant improvement in the health status of the patient. For this purpose, a 7-category ordinal scale was used, ranging from 1 ‘not hospitalised with resumption of normal activities’ to 7 ‘death’.
The intervention was not significantly different from placebo when the authors investigated the whole study population (P=0.73). However, the favipiravir arm was superior to the placebo arm in participants under 60 years of age (P=0.03). Similarly, secondary outcomes demonstrated that participants under 60 benefitted from favipiravir versus placebo in terms of ‘mechanical ventilation free survival’ (P=0.02).
Dr Orton added that these results implicate that a wider evaluation of anti-viral medications, including their age-stratified effects, should be considered in patients who are hospitalised with COVID-19.