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-19
  • start year

    2020
  • Known Financial Commitments (USD)

    $321,440
  • Funder

    Agence nationale de recherche sur le sida et les hépatites virale [National Agency for AIDS Research] (ANRS)
  • Principle Investigator

    Pending
  • Research Location

    Cote d'Ivoire, Africa
  • Lead Research Institution

    Université de Bordeaux, PACCI
  • Research Category

    Clinical characterisation and management

  • Research Subcategory

    Supportive care, processes of care and management

  • Special Interest Tags

    Gender

  • Study Subject

    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).