Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on Survival in Elderly Hospitalized Patients with VIDOC-19 : A Randomized, Multi-Centre, Adaptive, Blinded Study

Phase 1

• Conditions: COVID-19 infection; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-001303-16-FR
• Lead Sponsor: Hôpitaux Universitaires de Strasbourg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-29
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

- Subject Male or female age = 75, or = 60 if dementia
- Subject infected with COVID 19 (confirmed by RT-PCR SARS-CoV-2 detectable less than 5 days old and clinical picture)
- Clinical manifestation of COVID 19 requiring hospitalization
- Subject affiliated to a social health insurance scheme
- Subject capable of understanding the objectives and risks of the research and of giving dated and signed informed consent, or agreement given by a trusted person, guardian or trustee.
- Subject who has been informed of the results of the prior medical examination
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1100

Exclusion Criteria

Patients with a negative RT-PCR SARS-CoV-2 result
- Patients with COVID19 pneumopathy requiring resuscitative breathing support
- Patient on Sartan (Telmisartan, Candesartan, Valsartan, etc...), another antihypertensive, Hydroxychloroquine or Chloroquine, or macrolides (Azithromycin, Clarythromycyin...) within the last 24 hours.
- Patient with a contraindication to one of the treatments proposed in the study
- Contraindication Hydroxychloroquine: citalopram, escitalopram, hydroxyzine, domperidone, piperaquine, QT prolongation (>470ms for men and >480 ms for women), retinopathy, hypersensitivity to the active substances or to one of the excipients.
- Contraindication Azithromycin: combination with ergot derivatives, combination with colchicine, patients at risk of developing cardiac arrhythmia (diagnosis of QT interval prolongation (>470ms for men and >480 ms for women), severe hepatic impairment, history of allergy to macrolides or any of the excipients used in this study.
- Contraindication Telmisartan: Combination with drugs containing aliskiren, severe hepatic impairment, biliary obstruction, hypersensitivity to the active substance or to any of the excipients used in this study.
- Subject under safeguard of justice

Study & Design

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