A Randomised Controlled Trial of Early Intervention in Patients HospItalised with COVID-19: Favipiravir verses HydroxycholorquiNe & Azithromycin & Zinc vErsEs Standard CaRe

Phase 1

• Conditions: COVID-19 Infection; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001449-38-GB
• Lead Sponsor: Chelsea and Westminster Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-17
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 450

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,
-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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

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
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified