COVID-19 infection
Conditions
Interventions
Trade Name: Plaquenil
Product Name: Hydroxychloroquine
Pharmaceutical Form: Tablet
Trade Name: Telmisartan EG
Product Name: Telmisartan
Pharmaceutical Form: Tablet
Trade Name: Azithromycine EG
Produ
Sponsors
Hôpitaux Universitaires de Strasbourg
Eligibility
Sex/Gender
All
Inclusion 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 - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1100
Exclusion criteria
Exclusion criteria: Patients with a negative RT-PCR SARS-CoV-2 result - Patients with COVID19 pneumopathy requiring resuscitative breathing support - 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. - Contraindication Azithromycin: combination with ergot derivatives, combination with colchicine, patients at risk of developing cardiac arrhythmia (diagnosis of QT interval prolongation (>470ms for men and >480 ms for women), severe hepatic impairment, history of allergy to macrolides or any of the excipients used in this study. - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate the survival interest of Hydroxychloroquine 400 mg, Telmisartan 80 mg, Azithromycin 500 mg and Curcumin 800 mg daily on the survival of elderly patients with VIDOC-19 at 2 weeks from the start of treatment.;Secondary Objective: To evaluate adverse events, and particulary serious adverse avent. ToEvaluate the effectiveness of different treatments on : - SARS-Cov-2 - Survival to 4 weeks - Inflammation - The confusion - Walking - Functional capabilities - Breathing rate -Oxygen therapy - Pulse rate - Systolic and diastolic blood pressure - Temperature - Pneumonia - Discharge - Transfer to a convalescent hospital (SSR or equivalent) - Necessity of add-on coritcosteroids or other immunomodulator or immunosuppressor - Oxygen therapy - The impulse rate - Systolic and diastolic blood pressure - The temperature - Pneumonia - The return home - Disclaimer - Transfer to a convalescent hospital (RHS or equivalent) - The need for treatment with complementary, immonumodulating or immunosuppressive corticosteroids.;Primary end point(s): The primary endpoint will be two-weeks survival rate.;Timepoint(s) of evaluation of this end point: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints will be: - Serious adverse events rate - SARS RT-PCR-Cov-2 at 7 and 14 days - The 28-day death rate - The evolution of the CRP at 7 and 14 days - Blood count evolution at 7 and 14 days of age - And on a 7 and 14 day frame o Hypotensive systolic or diastolic blood pressure Temperature 40 ° C o Pneumonia Severity Index (PSI) (Hung et al 2017), o Non-cough rate, o The rate of absence of dyspnea o Rate of absence of fever o The rate of non-requirement of supplementary oxygen - The rate of SARS-Cov-2 undetectable at 7 and 14 days - Recovery time - Critical care admission rate - The mechanical ventilation rate. At regular intervals of 3 days: - The evolution of the 4-meter walking test, - Changes in Activity of Daily Living (ADL) and IADL (Instrumental Activity of Daily Living) - The evolution of the 4AT confusion scale - The number and dose of added corticosteroids, immonumodulators or immunosuppressants.;Timepoint(s) of evaluation of this end point: 7, 14 and 28 days | — |
Countries
France
Contacts
Public ContactEric DEMONSANT
Hôpitaux Universitaires de Strasbourg
Outcome results
None listed