Early Intervention in COVID-19: Favipiravir Verses Standard Care
NCT ID: NCT04373733
Last Updated: 2021-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
502 participants
INTERVENTIONAL
2020-05-01
2021-06-25
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Favipiravir & Standard of Care
Favipiravir: Day 1 1800mg twice per day, Days 2-10 800mg twice per day
Favipiravir
Anti-viral
Standard of care management
Standard of care management for COVID-19
Standard of care
No trial intervention
Standard of care management
Standard of care management for COVID-19
Interventions
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Favipiravir
Anti-viral
Standard of care management
Standard of care management for COVID-19
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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NEAT ID Foundation
OTHER
FUJIFILM Toyama Chemical Co., Ltd.
INDUSTRY
Imperial College London
OTHER
Chelsea and Westminster NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Pallav Shah
Role: PRINCIPAL_INVESTIGATOR
Chelsea and Westminster NHS Foundation Trust
Locations
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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
Countries
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References
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Shah PL, Orton CM, Grinsztejn B, Donaldson GC, Crabtree Ramirez B, Tonkin J, Santos BR, Cardoso SW, Ritchie AI, Conway F, Riberio MPD, Wiseman DJ, Tana A, Vijayakumar B, Caneja C, Leaper C, Mann B, Samson A, Bhavsar PK, Boffito M, Johnson MR, Pozniak A, Pelly M; PIONEER trial group. Favipiravir in patients hospitalised with COVID-19 (PIONEER trial): a multicentre, open-label, phase 3, randomised controlled trial of early intervention versus standard care. Lancet Respir Med. 2023 May;11(5):415-424. doi: 10.1016/S2213-2600(22)00412-X. Epub 2022 Dec 14.
Other Identifiers
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2020-001449-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CW002
Identifier Type: -
Identifier Source: org_study_id