Early Intervention in COVID-19: Favipiravir Verses Standard Care

NCT04373733 | Completed Phase 3 DMC

• 2 other identifiers: CW0022020-001449-38
• Study Type: interventional
• Target: 502
• Locations: 3 countries
• Sites: 6

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 suspected or proven COVID-19 infection.

Conditions

Coronavirus Infection

Keywords

COVID-19; Coronavirus

Outcome Measures

Primary Outcomes (1)

• Time from randomisation to a sustained clinical improvement (maintained for 24 hours) by two points on a seven-category ordinal scale or to discharge, whichever occurs first

  Time from randomisation to a sustained clinical improvement (maintained for 24 hours) by two points on a seven-category ordinal scale or to discharge, whichever occurs first The seven-category ordinal scale is : 1. Not hospitalised with resumption of normal activities 2. Not hospitalised, but unable to resume normal 3. Hospitalised, not requiring supplemental oxygen 4. Hospitalised, requiring supplemental oxygen 5. Hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation or both 6. Hospitalised, requiring ECMO (Extra-corporal membrane oxygenation), invasive mechanical ventilation or both 7. Death

  Up to 28 days from randomisation

Secondary Outcomes (13)

• Clinical status on a seven-category ordinal scale (Day 7)

  Day 7 from randomisation

• Clinical status on a seven-category ordinal scale (Day 14)

  Day 14 from randomisation

• Overall survival

  28 days from randomisation

• Time to improvement by two points on the NEWS score

  Up to 28 days from randomisation

• Time to improvement by two points on the NEWS element score for temperature

  Up to 28 days from randomisation

Other Outcomes (1)

• Readmission to inpatient care

  Up to 28 days from randomisation

Study Arms (2)

Favipiravir & Standard of Care

EXPERIMENTAL

Favipiravir: Day 1 1800mg twice per day, Days 2-10 800mg twice per day

Drug: Favipiravir; Other: Standard of care management

Standard of care

OTHER

No trial intervention

Other: Standard of care management

Interventions

Favipiravir DRUG

Anti-viral

Also known as: Avigan

Favipiravir & Standard of Care

Standard of care management OTHER

Standard of care management for COVID-19

Favipiravir & Standard of Care; Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead
• NEAT ID Foundation: collaborator
• FUJIFILM Toyama Chemical Co., Ltd.: collaborator
• Imperial College London: collaborator

Study Sites (6)

Grupo Hospitalar Conceição

Porto Alegre, Brazil

Location

Fundação Oswaldo Cruz - Instituto Nacional de Infectologia Evandro Chagas (Fiocruz/INI)

Rio de Janeiro, Brazil

Location

Instituto Nacional de Ciencias Medicas y Nutricion, Salvador Zubiran

Mexico City, Mexico

Location

Hull University Teaching Hospitals NHS Trust - Castle Hill Hospital

Hull, United Kingdom

Location

Chelsea and Westminster Hospital

London, United Kingdom

Location

West Middlesex University Hospital

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36528039 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

favipiravir

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pallav Shah

  Chelsea and Westminster NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label parallel group randomised control trial. One trial treatment arm and one standard of care comparator arm.

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 4, 2020
• Study Start: May 1, 2020
• Primary Completion: June 25, 2021
• Study Completion: June 25, 2021
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2); GB (3); ME (1)