NCT04373733

Early Intervention in COVID-19: Favipiravir Verses Standard Care

A Randomised Controlled Trial of Early Intervention in Patients HospItalised With COVID-19: Favipiravir and StaNdard Care vErsEs Standard CaRe

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 502 (actual)
• Sponsor: Chelsea and Westminster NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Currently we do not know how best to treat patients infected with COVID-19. This study is looking at whether randomising participants to either favipiravir or to usual care, can help patients with suspected or proven COVID-19 infection.

Detailed description

A prospective, randomised, open label study of the combined use of favipiravir and standard clinical care verses standard clinical care alone. A computer-based software will randomise participants 1:1 to either receive favipiravir and standard medical care or standard medical care alone. The allocated medical regime will commence for 10 days. Research blood, sputum nose swab and urine samples will be collected at baseline, as well as between day 5 and 10, and between day 14 and 28 to enable comparative analyses. A COVID-19 antibody test will also be performed 14-28 days after randomisation. In the event of clinically indicated bronchoscopy taking place within 28 days of consent then additional bronchoscopy washing and brushing samples and paired blood sample will be taken for research purposes If a participant is discharged before one of the latter time points, they will be required to return to hospital (provided they are well enough) for the collection of repeat samples. Participants will be closely monitored whilst taking the study medications. Participants will study exit at subject death or 28 days post-randomisation.

Conditions

• Coronavirus Infection

Interventions

Type	Name	Description
DRUG	Favipiravir	Anti-viral
OTHER	Standard of care management	Standard of care management for COVID-19

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-06-25
• Completion: 2021-06-25
• First posted: 2020-05-04
• Last updated: 2021-11-18

Locations

6 sites across 3 countries: Brazil, Mexico, United Kingdom