Efficacy of hydroxychloroquine in preventing infection and reducing viral load and disease severity in SARS-CoV-2 infected pregnant women in Spain

Resumen del proyecto

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

Palabras clave

ensayo clínico randomizado doble ciego
gestación
hidroxicloroquina
ácido ascórbico
COVID-19
SARS-CoV-2

Convocatoria

Acción Estratégica en Salud (AES)

Periodo de ejecución

07/10/2021 - 08/01/2022

Investigador Principal

CLARA MENENDEZ SANTOS

Centro beneficiario

FUNDACION PRIVADA INSTITUTO DE SALUD GLOBAL BARCELONA (ISGLOBAL)

Centro de realización

FUNDACION PRIVADA INSTITUTO DE SALUD GLOBAL BARCELONA (ISGLOBAL)

Comunidad Autónoma

CATALUÑA

Provincia

BARCELONA

Financiación

530,100 €