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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001449-38 | EudraCT Number |
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| Name | Class |
|---|---|
| NEAT ID Foundation | OTHER |
| FUJIFILM Toyama Chemical Co., Ltd. | INDUSTRY |
| Imperial College London | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Favipiravir & Standard of Care | Experimental | Favipiravir: Day 1 1800mg twice per day, Days 2-10 800mg twice per day |
|
| Standard of care | Other | No trial intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Favipiravir | Drug | Anti-viral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
| Up to 28 days from randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 7 from randomisation |
| Clinical status on a seven-category ordinal scale (Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Readmission to inpatient care | Frequency of readmission to inpatient care of patients discharged from hospital. | Up to 28 days from randomisation |
Inclusion Criteria:
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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Pallav Shah | Chelsea and Westminster NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grupo Hospitalar Conceição | Porto Alegre | Brazil | ||||
| Fundação Oswaldo Cruz - Instituto Nacional de Infectologia Evandro Chagas (Fiocruz/INI) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36528039 | Derived | 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. |
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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.
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C462182 | favipiravir |
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Open-label parallel group randomised control trial. One trial treatment arm and one standard of care comparator arm.
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Open label
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| Standard of care management | Other | Standard of care management for COVID-19 |
|
Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)
| Day 14 from randomisation |
| Overall survival | Survival of patients to end of study | 28 days from randomisation |
| 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 | Up to 28 days from randomisation |
| 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 | Up to 28 days from randomisation |
| 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 | Up to 28 days from randomisation |
| 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 | Up to 28 days from randomisation |
| 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 | Up to 28 days from randomisation |
| Admission to intensive care | Frequency of admission of patients to intensive care | Up to 28 days from randomisation |
| Requirement for mechanical ventilation | Frequency of requirement to administer mechanical ventilation to patients | Up to 28 days from randomisation |
| 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 | Up to 28 days from randomisation |
| Incidence of bacterial or fungal infection | Frequency of culture-confirmed bacterial or fungal infection in patients | Up to 28 days from randomisation |
| 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. | Up to 28 days from randomisation. |
| 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 |
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |