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Coronavirus InfectionPhase 3PIONEERNCT04373733

Early Intervention in COVID-19: Favipiravir Verses Standard Care

A Phase 3 study testing Favipiravir in people with Coronavirus Infection, run by Chelsea and Westminster NHS Foundation Trust at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus Infection
What is being tested?
Favipiravir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
502 participants
Where
6 sitesin 3 countries
Study dates
1 May 2020to 25 Jun 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

United Kingdom3 sites

  • Hull University Teaching Hospitals NHS Trust - Castle Hill Hospital

    Hull

  • Chelsea and Westminster Hospital

    London

  • West Middlesex University Hospital

    London

Other trials in United Kingdom

Brazil2 sites

  • Grupo Hospitalar Conceição

    Porto Alegre

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

    Rio de Janeiro

Other trials in Brazil

Mexico1 site

  • Instituto Nacional de Ciencias Medicas y Nutricion, Salvador Zubiran

    Mexico City

Other trials in Mexico

About this study

Official title: A Randomised Controlled Trial of Early Intervention in Patients HospItalised With COVID-19: Favipiravir and StaNdard Care vErsEs Standard CaRe

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.

Read the 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 1:1 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.

Being tested
Favipiravir, Standard of care management
Keywords
COVID-19, Coronavirus
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FavipiravirDrug

    Also called Avigan

    Anti-viral

  • Standard of care managementOther

    Standard of care management for COVID-19

Study groups in NCT04373733
Study groupRoleWhat they receive
Favipiravir & Standard of CareExperimentalFavipiravir: Day 1 1800mg twice per day, Days 2-10 800mg twice per day
Receives: Drug: Favipiravir; Other: Standard of care management
Standard of careOtherNo trial intervention
Receives: Other: Standard of care management

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 28 days from randomisation

Secondary outcomes (13)

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

    Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)

    Measured: Day 7 from randomisation

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

    Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)

    Measured: Day 14 from randomisation

  3. Overall survival

    Survival of patients to end of study

    Measured: 28 days from randomisation

  4. Time to improvement by two points on the NEWS score

    Time from randomisation to improvement by two points on the NEWS score of patient condition, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

    Measured: Up to 28 days from randomisation

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

    Time from randomisation to improvement by two points on the NEWS element score for temperature, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

    Measured: Up to 28 days from randomisation

  6. Time to improvement by two points on the NEWS element score for heartrate

    Time from randomisation to improvement by two points on the NEWS element score for heartrate, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

    Measured: Up to 28 days from randomisation

  7. Time to improvement by two points on the NEWS element score for respiratory rate

    Time from randomisation to improvement by two points on the NEWS element score for respiratory rate, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

    Measured: Up to 28 days from randomisation

  8. Time to improvement by two points on the NEWS element score for oxygen saturation.

    Time from randomisation to improvement by two points on the NEWS element score for oxygen saturation, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

    Measured: Up to 28 days from randomisation

  9. Admission to intensive care

    Frequency of admission of patients to intensive care

    Measured: Up to 28 days from randomisation

  10. Requirement for mechanical ventilation

    Frequency of requirement to administer mechanical ventilation to patients

    Measured: Up to 28 days from randomisation

  11. Requirement for non-invasive ventilation, continuous positive airways pressure or high-flow oxygen

    Frequency of requirement to administer non-invasive ventilation, continuous positive airways pressure or high-flow oxygen to patients

    Measured: Up to 28 days from randomisation

  12. Incidence of bacterial or fungal infection

    Frequency of culture-confirmed bacterial or fungal infection in patients

    Measured: Up to 28 days from randomisation

  13. Incidence of adverse events not directly caused by COVID-19 infection.

    Frequency and severity of adverse events in patients not directly attributed by clinicians to COVID-19 infection.

    Measured: Up to 28 days from randomisation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2020
  2. Study start1 May 2020
  3. Primary completion25 Jun 2021
  4. Study completion25 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label parallel group randomised control trial. One trial treatment arm and one standard of care comparator arm.
Masking
None (open label)
Enrolment
502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04373733
Sponsor's protocol ID
CW002
Other IDs
2020-001449-38
Acronym
PIONEER
Status last verified
Nov 2021
First submitted
1 May 2020
Last updated
18 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Research team wishes to enable any meta-analyses of COVID-19 trials making appropriate requests. No plan to share IPD has been made at this time.

Publications

  • 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.

    PubMed 36528039

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Favipiravir in people with Coronavirus Infection, run by Chelsea and Westminster NHS Foundation Trust at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom, Brazil, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 frame: Up to 28 days from randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04373733, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.

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