COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001449-38/GB

Chelsea and Westminster Hospital NHS Foundation Trust - Research and Development Office

research.development@chelwest.nhs.uk

2020-04-17

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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, - 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. 5. 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

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 10. Immunocompromised patients (see Appendix C) 11. Known sensitivity to Azithromycin (or other macrolide drugs), Hydroxychloroquine, zinc or Favipiravir NB See Section 9.1 for dose reduction guidance for patients with eGFR <50ml/ minute

3

Chelsea and Westminster Hospital NHS Foundation Trust

18

None

United Kingdom

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

450

Time to clinical improvement (post randomisation) by two points on a seven-category ordinal scale or live discharge from the hospital, whichever comes first The seven-category ordinal scale: 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

nan

Phase 3

[{"arm_notes": "", "treatment_id": 1543, "treatment_name": "Azithromycin+hydroxychloroquine+zinc", "treatment_type": "Antibiotics+antimalarials+vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]