Status:
COMPLETED
Early Intervention in COVID-19: Favipiravir Verses Standard Care
Lead Sponsor:
Chelsea and Westminster NHS Foundation Trust
Collaborating Sponsors:
NEAT ID Foundation
FUJIFILM Toyama Chemical Co., Ltd.
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 sus...
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:...
Eligibility Criteria
Inclusion
- Adult participants: Signed informed consent
- New admission to hospital for period expected to last ≥ 1 night
- 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
- 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.
- 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
- Pregnant or breast feeding, due to potential teratogenicity
- Hepatic impairment - (AST or ALT \> 3.5 x upper limit of normal)
- Presently enrolled in an interventional drug study
- Unable to take medication via the oral or nasogastric route
- Known sensitivity Favipiravir
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2021
Estimated Enrollment :
502 Patients enrolled
Trial Details
Trial ID
NCT04373733
Start Date
May 1 2020
End Date
June 25 2021
Last Update
November 18 2021
Active Locations (6)
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1
Grupo Hospitalar Conceição
Porto Alegre, Brazil
2
Fundação Oswaldo Cruz - Instituto Nacional de Infectologia Evandro Chagas (Fiocruz/INI)
Rio de Janeiro, Brazil
3
Instituto Nacional de Ciencias Medicas y Nutricion, Salvador Zubiran
Mexico City, Mexico
4
Hull University Teaching Hospitals NHS Trust - Castle Hill Hospital
Hull, United Kingdom