Status:
TERMINATED
Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
COVID-19 Infection
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief 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...
Detailed Description
In the absence of a validated treatment, any patient over 75 years -or demented above 60- of age arriving in one of our hospital centres with a COVID19 infection objectified by RT-PCR will be offered ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04359953
Start Date
April 25 2020
End Date
June 1 2022
Last Update
July 11 2022
Active Locations (1)
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1
CHU de Strasbourg
Strasbourg, France, 67000