EUCTR2020-001449-38-GB
Active, Not Recruiting
Phase 1
A Randomised Controlled Trial of Early Intervention in Patients HospItalised with COVID-19: Favipiravir verses HydroxycholorquiNe & Azithromycin & Zinc vErsEs Standard CaRe - PIONEER
Chelsea and Westminster Hospital NHS Foundation Trust0 sites450 target enrollmentApril 17, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19 Infection
- Sponsor
- Chelsea and Westminster Hospital NHS Foundation Trust
- Enrollment
- 450
- Status
- Active, Not Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •he participant may enter the study if the following apply:
- •1\.Adult participants: Signed informed consent
- •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 one of 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).
- •·Acute respiratory distress syndrome
- •·Radiological evidence of pneumonia
- •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,
Exclusion Criteria
- •The participant may not enter the study if ANY of the following apply:
- •1\.Pregnant or breast feeding, due to potential teratogenicity
- •2\.Hepatic impairment – (AST or ALT \> 3\.5 x upper limit of normal)
- •3\.Renal impairment – (eGFR \<10ml/ minute)
- •4\.Known history of retinopathy
- •5\.Known history of G6PD deficiency
- •6\.Known history of Myasthenia gravis
- •7\.QT\-prolongation (\>430ms in males or \>450ms in females, calculated as per investigators discretion)
- •8\.Presently enrolled in an interventional drug study or on hydroxychloroquine or azithromycin for other therapeutic reasons
- •9\.Unable to take medication via the oral or nasogastric route
Outcomes
Primary Outcomes
Not specified
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