TT and PT: Hidroxicloroquina for pregnant women infected by SARS-CoV-2. Hidroxicloroquina for healthy PW as COVID19 preventive treatment. Efficacy of hydroxychloroquine in preventing infection and reducing viral load and disease severity in SARS-CoV-2 infected pregnant women in Spain

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

Grant number: unknown

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Key facts

  • Disease

    COVID-19
  • Known Financial Commitments (USD)

    $572,508
  • Funder

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

    Pending
  • Research Location

    Spain, Europe
  • Lead Research Institution

    ISGlobal (Barcelona)
  • Research Category

    Therapeutics research, development and implementation

  • Research Subcategory

    Prophylactic use of treatments

  • Special Interest Tags

    Gender

  • Study Subject

    Clinical

  • Clinical Trial Details

    Randomized Controlled Trial

  • Broad Policy Alignment

    Pending

  • Age Group

    Adults (18 and older)Newborns (birth to 1 month)

  • Vulnerable Population

    Pregnant women

  • Occupations of Interest

    Unspecified

Abstract

TT and PT: Hidroxicloroquina for pregnant women infected by SARS-CoV-2. Hidroxicloroquina for healthy PW as COVID19 preventive treatment.Efficacy of hydroxychloroquine in preventing infection and reducing viral load and disease severity in SARS-CoV-2 infected pregnant women in Spain It is unclear how SARS-CoV-2 affects pregnant women and their offspring, as well as which factors may influence obstetrical disease and outcomes. This will be a randomized, double blinded, placebo-equivalent controlled multicentre trial aiming to assess the effect of hydroxychloroquine (HCQ) in reducing maternal viral load and the efficacy of HCQ to prevent incident SARS-CoV-2 infection. Pregnant women of any gestational age, parity and age, undergoing pre-natal follow up at four maternity hospitals with a positive PCR test, or who are contacts of a confirmed case, will be recruited and randomised 1:1 to receive HCQ orally (400 mg/day for 3 days, followed by 200 mg/day for 11 days) or ascorbic acid orally (500 mg for 3 days, then 250 mg/day for 11 days). Women will be followed up for the duration of the intervention when PCR tests for SARS-CoV-2 will be repeated, and up to delivery, when the pregnancy outcome will be registered, a cord blood sample and a neonatal throat swab will be collected after birth to be tested for SARS-CoV-2