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