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

NCT04359953 | Terminated Phase 3 DMC

• 1 other identifier: 7747
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Infection

Keywords

COVID-19; Elderly; Therapeutic study

Outcome Measures

Primary Outcomes (1)

• Two-weeks survival rate

  Day 14

Secondary Outcomes (27)

• Rate of undetectable RT-PCR of SARS-CoV-2

  Day 7

• Rate of undetectable RT-PCR of SARS-CoV-2

  Day 14

• Rate of death

  Day 28

• Hypotension

  Day 7

• Hypotension

  Day 14

Study Arms (4)

Hydroxychloroquine

EXPERIMENTAL

Patient will take 200mg of Hydroxychloroquine twice a day during 14 days

Drug: Hydroxychloroquine

Azithromycin

EXPERIMENTAL

Patient will take 250mg of Azithromycin twice a day during 14 days

Drug: Azithromycin

Telmisartan

EXPERIMENTAL

Patient will take 40mg of Telmisartan twice a day during 14 days

Drug: Telmisartan

Usual Care

NO INTERVENTION

No intervention

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine 2 x per day during 14 days

Hydroxychloroquine

Azithromycin DRUG

Azithromycin 2 x per day during 14 days

Azithromycin

Telmisartan DRUG

Telmisartan 2 x per day during 14 days

Telmisartan

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

CHU de Strasbourg

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Azithromycin; Telmisartan

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzimidazoles

Study Officials

• Frédéric BLANC

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 24, 2020
• Study Start: April 25, 2020
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

FR (1)