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-19Known Financial Commitments (USD)
$572,508Funder
National Institute of Health Carlos III [El Instituto de Salud Carlos III] (ISCIII)Principal Investigator
Clara Menéndez SantosResearch Location
SpainLead Research Institution
ISGlobal (Barcelona)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
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