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Treatment of patients with COVID-19 and non-severe pneumonia without hospital admission criteria: randomized clinical trial Protocol Code: COME-CLEAN EUDRACT 2020-001962-12

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

Grant number: COV20_00644

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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

    Carlos Guijarro Herraiz

  • Research Location

    Spain

  • Lead Research Institution

    Hospital Universitario Fundación Alcorcón

  • Research Priority Alignment

    N/A

  • Research Category

    Therapeutics research, development and implementation

  • Research Subcategory

    Prophylactic use of treatments

  • Special Interest Tags

    N/A

  • Study Type

    Clinical

  • Clinical Trial Details

    Randomized Controlled Trial

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

Objectives: to evaluate the effectiveness of 4 active treatment regimens in monotherapy (hydroxychloroquine, Prednisone, Azithromycin, or Colchicine) versus placebo in patients with COVID-19 with non-severe pneumonia without criteria for admission measured as hospital admission or death in the following 2 weeks after the start of treatment; evaluate and compare the safety of treatment guidelines at 28 days and describe the changes that occurred in the perception of health status at 12 weeks and analyze the impact of various clinical and sociodemographic factors on these potential changes. Design: Randomized, multicenter, double-blind, placebo-controlled clinical trial. N = 1711. Intention-to-treat analysis.