Hydroxychloroquine for hospitalized patients with COVID19 [COVID-19]

  • Research type

    Research Study

  • Full title

    An adaptive Phase 2/3, randomized, open-label study assessing efficacy and safety of hydroxychloroquine for hospitalized patients with moderate to severe COVID-19

  • IRAS ID

    282362

  • Contact name

    Dinesh Saralaya

  • Contact email

    Dinesh.Saralaya@bthft.nhs.uk

  • Sponsor organisation

    sanofi-aventis recherche & développement

  • Eudract number

    2020-001270-29

  • Duration of Study in the UK

    0 years, 2 months, 11 days

  • Research summary

    This study is an adaptive, multi-national, multi-center, randomized, open-label, Phase 2/3 trial to evaluate the efficacy and safety of Hydroxychloroquine in addition to standard of care as compared to standard of care only in hospitalized adult patients with moderate to severe COVID-19.\nThere are currently no effective drugs for the treatment of patients with moderate to severe COVID-19. Investigations aiming to evaluate the safety and effectiveness of novel or repurposed medications in moderate to severe COVID-19 are needed to identify safe and effective agents that could help individuals and societies impacted by the SARS-CoV-2 pandemic.\n

  • REC name

    North East - Newcastle & North Tyneside 2 Research Ethics Committee

  • REC reference

    20/NE/0108

  • Date of REC Opinion

    2 Apr 2020

  • REC opinion

    Further Information Favourable Opinion