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Prevention of COVID19 infection by administration of hydroxychloroquine in institutionalized elderly and nursing home care personnel. Controlled, open and randomized stepped-wedge clinical trial by clusters

  • Funded by National Institute of Health Carlos III [El Instituto de Salud Carlos III] (ISCIII)
  • Total publications:0 publications

Grant number: COV20_00565

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Key facts

  • Disease

    COVID-19

  • Funder

    National Institute of Health Carlos III [El Instituto de Salud Carlos III] (ISCIII)

  • Principal Investigator

    JOSÉ MIGUEL MORALES ASENCIO

  • Research Location

    Spain

  • Lead Research Institution

    FUNDACION PARA LA INVESTIGACION DE MALAGA EN BIOMEDICINA Y SALUD (FIMABIS)

  • Research Priority Alignment

    N/A

  • Research Category

    Epidemiological studies

  • Research Subcategory

    Disease surveillance & mapping

  • Special Interest Tags

    N/A

  • Study Type

    Clinical

  • Clinical Trial Details

    Randomized Controlled Trial

  • Broad Policy Alignment

    Pending

  • Age Group

    Adults (18 and older)Older adults (65 and older)

  • Vulnerable Population

    Other

  • Occupations of Interest

    Health PersonnelUnspecified

Abstract

Objective: To evaluate the effectiveness of chemoprophylaxis with hydroxychloroquine in healthcare personnel and residents: a) on the incidence of secondary cases of SARS-CoV-2 infection in residents, and b) on the incidence of SARS-CoV-2 infection in the staff themselves . Evaluate the effect of measures to promote infection control. Design: Staggered, randomized, open-label, controlled study. Subjects: institutionalized elderly and direct care professionals in 4 Autonomous Communities. Sample: 880 professionals, 1050 residents in 84 residences. They will be given 800mg of HCQ on the first day and 400mg for four days. Nasopharyngeal swab will be taken for baseline RT-PCR, 6 and 14 days and baseline serology and 28 days. Mortality, compliance, safety, symptoms, admission and viral load will be evaluated secondarily.