Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

In November 2019, Wuhan city in China, became the center of an outbreak of pneumonia due to a novel coronavirus SARS-CoV-2, which disease was named coronavirus disease 2019 (COVID19) in February, 2020. The COVID19 is much more dangerous for people over 60 with a death rate of 3.6% after 60, 8.0% after 70 and 14.8% after 80 -and according to our Italian colleagues over 20% after 90- against 2.3% in the general population. The elderly patients who died most often had multiple comorbidities and in particular: cardiovascular disease (10.5% mortality), diabetes (7.3%), chronic respiratory disease (6.3%) and hypertension (6%). These elderly patients with COVID19 are therefore very fragile and require treatment that fights the virus but is also adapted to their state of health and age. Most of current therapeutic trials worldwide exclude people aged over 75 years, which is precisely the age group affected by COVID19. We therefore propose to carry out a therapeutic trial specific to the elderly with drugs at doses that are bearable for these patients. Using the WHO, clinicaltrial, pubmed and the Chinese CCDC/CHCTR websites to find the better drugs adapted to elderly people, we decided after concertation between infectiologists and geriatricians to do a four arms clinical trial during two weeks twice a day: Hydroxychloroquine 200mg, Telmisartan 40mg, Azithromycin 250mg and standard care. We therefore hypothesize that one or more of these treatments may have a beneficial effect in controlling COVID19, without major and repeated side effects in elderly patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Strasbourg, France
• Treatments: Azithromycin; Hydroxychloroquine; Telmisartan

Criteria

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:

pneumopathy and/or upper airway infection and/or respiratory distress, confusion and/or encephalopathy and/or signs of encephalitis, walking disorders with ataxia and/or falls, digestive problem (diarrhea and/or vomiting)

• 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

Exclusion Criteria:

• Patients with a negative RT-PCR SARS-CoV-2 result

• Patients with COVID19 pneumopathy requiring resuscitative breathing support

• Porphyria

• Kaliemia 3.5 mmol/l and 5.5 mmol/l

• Any reason why patient follow-up would be impossible during the study period

• 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, known deficit in G6PD

• Contraindication Azithromycin: combination with ergot derivatives, combination with colchicine, patients at risk of developing cardiac arrhythmia (diagnosis of QTc interval prolongation (>470ms for men and >480 ms for women), severe hepatic impairment,severe cholestase, history of allergy to macrolides or any of the excipients used in this study, end-stage renal failure with a glomerular filtration rate (DFG) - 15 ml/min, patients with malignant hemopathies who have undergone an allograft of hematopoietic stem cells

• 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