Recherche Clinique (Clinical Research) - INTENSE-COV - Évaluation de combinaisons thérapeutiques pour améliorer le pronostic de l'infection à COVID-19 et réduire la contamination en Côte d'Ivoire : un essai contrôlé randomisé de phase IIb. INTENSE-COV - Combination therapy to improve outcome of COVID-19 infection and decrease contamination of relatives in Côte d'Ivoire : a randomized controlled phase IIb study.
- Funded by Agence nationale de recherche sur le sida et les hépatites virale [National Agency for AIDS Research] (ANRS)
- Total publications:0 publications
Grant number: ANRS COV01
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Key facts
Disease
COVID-19start year
2020Known Financial Commitments (USD)
$321,440Funder
Agence nationale de recherche sur le sida et les hépatites virale [National Agency for AIDS Research] (ANRS)Principal Investigator
Fabrice BONNET, Serge EHOLIEResearch Location
Cote d'IvoireLead Research Institution
Université de Bordeaux, PACCIResearch Priority Alignment
N/A
Research Category
Clinical characterisation and management
Research Subcategory
Supportive care, processes of care and management
Special Interest Tags
N/A
Study Type
Clinical
Clinical Trial Details
Clinical Trial, Phase II
Broad Policy Alignment
Pending
Age Group
Adults (18 and older)
Vulnerable Population
Unspecified
Occupations of Interest
Unspecified
Abstract
Study Desing: Randomized, comparative, multicenter, phase IIb, superiority, parallel arm, unblinded trial to evaluate the efficacy and safety of two combination therapies versus monotherapy against SARS-CoV-2 for 10 days in adults living in Abidjan, Côte d'Ivoire. Main objective: To compare the efficacy of two antiviral and anti-inflammatory combination therapies versus lopinavir/ritonavir antiviral monotherapy on the reduction of nasopharyngeal carriage of CoV-2 SARS and the reduction of inflammatory syndrome during COVID-19. Inclusion criteria: Patients over 18 years of age, with an SARS-CoV-2 infection confirmed by specific PCR, with clinical manifestations of the infection, such as fever or cough or ENT signs or breathing difficulties, Naïve to specific treatment for COVID-19,Women of childbearing age should accept the use of mechanical contraception during the study period, Informed consent signed by the patient. Trial treatments Participants will be randomized into 3 groups: - Group 1: lopinavir/ritonavir - Group 2: lopinavir/ritonavir + telmisartan - Group 3: lopinavir/ritonavir + atorvastatin The duration of treatment will be 10 days in each treatment group. Primary Endpoint : Proportion of patients with undetectable nasopharyngeal swab SARS-CoV-2 PCR and CRP < 27 mg/L at D11. *Number of participants: 294 (98 per treatment group).