Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
450

Summary

Conditions
Coronavirus Infection
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Open-label parallel group randomised control trial. One trial treatment arm and one standard of care comparator arm.Masking: None (Open Label)Masking Description: Open labelPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 allocat...

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.

Tracking Information

NCT #
NCT04373733
Collaborators
  • NEAT ID Foundation
  • FUJIFILM Toyama Chemical Co., Ltd.
  • Imperial College London
Investigators
Principal Investigator: Pallav Shah Chelsea and Westminster NHS Foundation Trust