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.
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.
Drug: Favipiravir
Anti-viral
Other Name: Avigan
Other: Standard of care management
Standard of care management for COVID-19
Inclusion Criteria:
1. Adult participants: Signed informed consent
2. New admission to hospital for period expected to last ≥ 1 night
3. Suspected or confirmed COVID-19 infection
Patients are suspected of COVID-19 infection if they have the following:
· Influenza like illness (fever ≥37.8°C and at least one of the following respiratory
symptoms, which must be of acute onset: persistent cough, hoarseness, nasal discharge
or congestion, shortness of breath, sore throat, wheezing or sneezing).
And
· Finding from either a chest x-ray or CT suggestive of Covid-19 infection
And
· Alternative causes are considered unlikely
4. For women to be eligible to enter and participate in the study they should be: of
non-child-bearing
- potential defined as either post-menopausal (12 months of spontaneous amenorrhea
and ≥ 45 years of age) or physically incapable of becoming pregnant with
documented tubal ligation, hysterectomy or bilateral oophorectomy or,
- or of child-bearing potential have a negative pregnancy test at screening and
agrees to remain sexually abstinent or use a method of contraception with a
failure rate of < 1% per year as indicated in Appendix B during the treatment and
for a period of 7 days after the last dose. Hormonal contraceptive methods must
be supplemented by a barrier method.
5. Men who are sexually active must use an adequate method of contraception as listed in
Appendix B, for a period of at least 7 days after the last dose
Exclusion Criteria:
1. Pregnant or breast feeding, due to potential teratogenicity
2. Hepatic impairment - (AST or ALT > 3.5 x upper limit of normal)
3. Presently enrolled in an interventional drug study
4. Unable to take medication via the oral or nasogastric route
5. Known sensitivity Favipiravir
Grupo Hospitalar Conceição
Porto Alegre, Brazil
Fundação Oswaldo Cruz - Instituto Nacional de Infectologia Evandro Chagas (Fiocruz/INI)
Rio De Janeiro, Brazil
Instituto Nacional de Ciencias Medicas y Nutricion, Salvador Zubiran
Mexico City, Mexico
Hull University Teaching Hospitals NHS Trust - Castle Hill Hospital
Hull, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
West Middlesex University Hospital
London, United Kingdom
Pallav Shah, Principal Investigator
Chelsea and Westminster NHS Foundation Trust