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| Column | Value |
|---|---|
| Trial registration number | NCT04359953 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-24 |
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Recruitment status
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Terminated |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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 |
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- 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 |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
University Hospital, Strasbourg, France |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
60 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
France |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Moderate disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
3: Moderate disease at enrollment |
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Total sample size
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
16 |
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primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Two-weeks survival rate |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1274, "treatment_name": "Telmisartan", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 165, "treatment_name": "Azithromycin", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |