Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on Survival in Elderly Hospitalized Patients with VIDOC-19 : A Randomized, Multi-Centre, Adaptive, Blinded Study

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2020
INTERVENTION: Trade Name: Plaquenil Product Name: Hydroxychloroquine Pharmaceutical Form: Tablet Trade Name: Telmisartan EG Product Name: Telmisartan Pharmaceutical Form: Tablet Trade Name: Azithromycine EG Product Name: Azithromycine Pharmaceutical Form: Tablet Trade Name: Curcumin C3 Product Name: Curcumin Pharmaceutical Form: Capsule CONDITION: COVID‐19 infection Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: 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. Primary end point(s): The primary endpoint will be two‐weeks survival rate. 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. Timepoint(s) of evaluation of this end point: 14 days SECONDARY OUTCOME: 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 <35 ° C or >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 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
Epistemonikos ID: d9c1af1f4b793d3a4532854b9bae36f9cd766b30
First added on: May 13, 2020