PIONEER [COVID-19]
Research type
Research Study
Full title
A Randomised Controlled Trial of Early Intervention in Patients HospItalised with COVID-19: Favipiravir and StaNdard care vErsEs Standard CaRe
IRAS ID
282405
Contact name
Pallav Shah
Contact email
Sponsor organisation
Chelsea and Westminster Hospital
Eudract number
2020-001449-38
Duration of Study in the UK
0 years, 10 months, 0 days
Research 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 a combination of azithromycin, hydroxychloroquine and zinc or favipiravir alongside usual care, can help patients with suspected or proven COVID-19 infection.\n\nPrimary Objective\t\nTo determine whether early treatment intervention with either favipiravir or the combination of hydroxychloroquine, zinc and azithromcycin can significantly improve the clinical status in patients with COVID-19 infection\n\nSecondary Objectives\t\nTo assess whether early intervention with Favipiravir or the combination of hydroxychloroquine, zinc and azithromcycin improves mortality in patients with COVID-19 infection\n\nTo determine whether early intervention with favipiravir or the combination of hydroxychloroquine, zinc and azithromcycin reduces resource utilisation in patients with COVID-19 infection\n\nTo explore whether early intervention with favipiravir or the combination of hydroxychloroquine, zinc and azithromcycin attenuates the excessive inflammatory cytokine response in patients with COVID-19 infection\n\nParticipants will be allocated by 1:1:1 to receive one of three treatment regimens:\n•standard of care\n•Azithromycin, hydroxychloroquine and zinc sulphate + standard of care\n•Favipiravir + standard of care\n\nResearch samples:\nthe study will collect the following samples\n\n\nBaseline: 20ml Blood, Nasopharyngeal swab, urine, sputum\t\nDay 5-10: 20ml Blood, Nasopharyngeal swab, urine, sputum\t\nDay 14-28: 20ml Blood, Nasopharyngeal swab, urine, sputum, COVID-19 antibody test\n\n\nIn the event of clinically indicated bronchoscopy taking place within 28 days of consent then additional bronchoscopy wash sample and paired blood sample will be taken for research purposes.\n\nClinical information, patient outcomes, resource utilisation and inpatient results will be collected from the time that a participant joins the study until death or 28 days after joining.\n\n\n
REC name
North West - Haydock Research Ethics Committee
REC reference
20/NW/0219
Date of REC Opinion
17 Apr 2020
REC opinion
Further Information Favourable Opinion