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

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ClinicalTrials.gov Identifier: NCT04359953
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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. 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.

Condition or disease Intervention/treatment Phase
COVID-19 Infection Drug: Hydroxychloroquine Drug: Azithromycin Drug: Telmisartan Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19: a Randomized, Multicenter, Adaptative Study
Estimated Study Start Date : April 24, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021


Arm Intervention/treatment
Experimental: Hydroxychloroquine
Patient will take 200mg of Hydroxychloroquine twice a day during 14 days
Drug: Hydroxychloroquine
Hydroxychloroquine 2 x per day during 14 days

Experimental: Azithromycin
Patient will take 250mg of Azithromycin twice a day during 14 days
Drug: Azithromycin
Azithromycin 2 x per day during 14 days

Experimental: Telmisartan
Patient will take 40mg of Telmisartan twice a day during 14 days
Drug: Telmisartan
Telmisartan 2 x per day during 14 days

No Intervention: Usual Care
No intervention



Primary Outcome Measures :
  1. Two-weeks survival rate [ Time Frame: Day 14 ]

Secondary Outcome Measures :
  1. Rate of undetectable RT-PCR of SARS-CoV-2 [ Time Frame: Day 7 ]
  2. Rate of undetectable RT-PCR of SARS-CoV-2 [ Time Frame: Day 14 ]
  3. Rate of death [ Time Frame: Day 28 ]
  4. Hypotension [ Time Frame: Day 7 ]
  5. Hypotension [ Time Frame: Day 14 ]
  6. Hypothermia and hyperthermia [ Time Frame: Day 7 ]
  7. Hypothermia and hyperthermia [ Time Frame: Day 14 ]
  8. Pneumonia severity according to WHO [ Time Frame: Day 7 ]
  9. Pneumonia severity according to PSI (Hung et al 2017) [ Time Frame: Day 7 ]
  10. Pneumonia severity according to WHO [ Time Frame: Day 14 ]
  11. Pneumonia severity according to PSI (Hung et al 2017) [ Time Frame: Day 14 ]
  12. Rate of no cough [ Time Frame: Day 7 ]
  13. Rate of no cough [ Time Frame: Day 14 ]
  14. Rate of no dyspnea [ Time Frame: Day 7 ]
  15. Rate of no dyspnea [ Time Frame: Day 14 ]
  16. Rate of no fever [ Time Frame: Day 7 ]
  17. Rate of no fever [ Time Frame: Day 14 ]
  18. Rate of no requiring supplemental oxygen [ Time Frame: Day 7 ]
  19. Rate of no requiring supplemental oxygen [ Time Frame: Day 14 ]
  20. Rate of SARS-Cov-2 undetectable [ Time Frame: Day 7 ]
  21. Rate of SARS-Cov-2 undetectable [ Time Frame: Day 14 ]
  22. Recovery time [ Time Frame: Day 28 ]
  23. Critical admission rate [ Time Frame: Day 28 ]
  24. Mechanical ventilation rate [ Time Frame: Day 28 ]
  25. Changes in Activity of Daily Living (ADL) Activity of Daily Living) [ Time Frame: Day 13 ]
  26. Changes in Activity of Daily Living IADL (Instrumental Activity of Daily Living) [ Time Frame: Day 13 ]
  27. The number and dose of added corticosteroids, immonumodulators or immunosuppressants [ Time Frame: Day 14 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359953


Contacts
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Contact: Frédéric BLANC, MD 03 88 11 58 58 ext 003 frederic.blanc@chru-strasbourg.fr

Locations
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France
CHU de Strasbourg
Strasbourg, France, 67000
Contact: Frédéric BLANC, MD    03 88 11 58 58 ext 0033    frederic.blanc@chru-strasbourg.fr   
Principal Investigator: Frédéric BLANC, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Frédéric BLANC University Hospital, Strasbourg, France
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04359953    
Other Study ID Numbers: 7747
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
COVID-19
Elderly
Therapeutic study
Additional relevant MeSH terms:
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Azithromycin
Hydroxychloroquine
Telmisartan
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists