Hydroxychloroquine Efficacy and Safety in Preventing SARS-CoV-2 Infection and COVID-19 Disease Severity During Pregnancy and Postpartum

Summary

It still unclear how SARS-CoV-2 affects pregnant women and their offspring, as well as which factors may influence obstetrical disease and outcomes, including the timing of maternal viral exposure by gestational age, the effects of parity, age, host immune responses, coexisting medical and obstetrical conditions and the effects of treatment regimens. While further information is gathered, based on the existing evidence from other infections causing pneumonia, pregnant women should be considered to be at high risk for developing severe infection during the current COVID-19 epidemic. Results from clinical trials with HCQ in nonpregnant adults may not be directly extrapolated to pregnant women given the special features of the pregnancy status. Thus, clinical research is urgently needed to improve the care and reduce the risk of poor pregnancy outcomes of women in this and in future epidemics.

Conditions

• Pregnancy Related
• COVID
• Covid-19

Interventions

DRUG

Hydroxychloroquine

Participants will receive a bottle containing 19 tablets of study medication. They will be instructed to take two tablets for the first three days and one tablet for the following 11 days. (400 mg/day for three days, followed by 200 mg/day for 11 days).

DRUG

Placebo

Participants will receive a bottle containing 19 tablets of placebo. They will be instructed to take two tablets for the first three days and one tablet for the following 11 days.

Sponsors & Collaborators

• Hospital Clinic of Barcelona

  collaborator OTHER

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  collaborator OTHER

• University Hospital of Torrejon

  collaborator OTHER

• Fundación de investigación HM

  collaborator OTHER

• Hospital Sant Joan de Deu

  collaborator OTHER

• Hospital del Mar

  collaborator OTHER

• Hospital Universitario Infanta Leonor

  collaborator OTHER

• Hospital Universitario Fundación Alcorcón

  collaborator OTHER

• Hospital General de Segovia

  collaborator OTHER

• Institut Català de la Salut

  collaborator OTHER

• Barcelona Institute for Global Health

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-05-13

Primary Completion

2021-06-30

Completion

2021-10-31

Countries

• Spain

Study Locations