COVID-Preg: Efficacy and safety of hydroxychloroquine in preventing SARS-CoV-2 infection and severe COVID-19 illness during pregnancy

Principal Investigators

The Barcelona Institute for Global Health, ISGlobal, is the coordinator of this multicenter clinical trial aimed at evaluating the efficacy and safety of the drug hydroxychloroquine (HCQ) in preventing SARS-CoV-2 infection and the progression of COVID-19 symptoms during pregnancy. SJD Barcelona Children's Hospital is collaborating in the study together with eight other Spanish hospitals: Hospital Clínic (Barcelona), Hospital de la Santa Creu i Sant Pau (Barcelona), Hospital del Mar (Barcelona), HM Puerta del Sur (Madrid), Hospital Universitario de Torrejón (Madrid), Hospital Infanta Leonor (Madrid), Hospital de Alcorcón (Madrid) and Hospital General de Segovia (Segovia).

Rationale

  • Knowledge of the consequences of COVID-19 in pregnant women is still limited, and developing a severe disease may have significant implications.
  • At the moment, only non-pharmacological measures are recommended to prevent SARS-CoV-2 infection, such as social distancing, the use of masks and frequent washing of hands and cleaning of objects.
  • Despite there being no solid evidence of an effective pharmacological agent for the prevention and treatment of SARS-CoV-2 infection, some drugs such as HCQ that are used to treat other diseases have been repurposed to treat severe cases of COVID-19 and clinical trials were undertaken.
  • To assess the efficacy and safety of HCQ in preventing SARS-CoV-2 infection and severe COVID-19 illness during pregnancy, the conduct of clinical trials is crucial and needs to include pregnant women.

Project design

The COVID-Preg study has been designed as a randomized, placebo-controlled clinical trial with a sample size of 714 pregnant women to achieve the trial's scientific objectives.

Pregnant women who attend the hospitals involved in the clinical trial and report symptoms and/or signs of suspected COVID-19 illness or contact with a suspected or confirmed case of COVID-19 in the last six days will be invited to participate in the study.

Participants must be more than twelve weeks pregnant, have had close contact with a confirmed or suspected case of COVID-19 in the last two weeks, or have had symptoms consistent with COVID-19 disease. Only women who are contacts of a COVID-19 case, whether their PCR is positive or negative, and those with symptoms and a positive PCR test, will be included in the research and therefore will receive the study medication (HCQ or placebo).

Scientific objectives

Main:

  1. To evaluate the effect of HCQ in reducing the viral shedding of SARS-CoV-2 by PCR in infected pregnant women with mild symptoms.
  2. To evaluate the efficacy of HCQ to prevent SARS-CoV-2 infection in pregnant women who have been in contact with confirmed or suspected cases of COVID-19.
  3. To evaluate the effect of HCQ in preventing the development of COVID-19 disease in asymptomatic pregnant women infected with SARS-CoV-2.

Secondary:

  1. To determine the effect of HCQ on the clinical course and duration of COVID-19 disease in pregnant women infected with SARS-CoV-2.
  2. To determine the impact of HCQ on the risk of hospitalization and mortality in pregnant women infected with SARS-CoV-2.
  3. To evaluate the safety and tolerability of HCQ in pregnant women.
  4. To describe the clinical presentation of SARS-CoV-2 infection during pregnancy.
  5. To describe the effects of maternal SARS-CoV-2 infection on pregnancy and perinatal outcomes by treatment group.
  6. To determine the risk of vertical transmission (intra-utero and intra-partum) of SARS-CoV-2.

Data and samples

A sample will be taken from the nasopharynx of those pregnant women who meet the inclusion criteria and agree to participate in the clinical trial to perform a PCR test to determine whether they are infected.

Study participants will be stratified by clinical presentation and SARS-CoV-2 PCR results:

  • PCR positive for SARS-CoV-2: infected pregnant women:
    • symptomatic (n = 100)
    • asymptomatic (n = 100)
  • PCR negative for SARS-CoV-2: uninfected pregnant women who have had contact with a confirmed or suspected case (n = 514).

The women in each group will be randomized to receive either HCQ or a placebo.

Research team at ISGlobal (project coordinator)

  • Clara Menéndez

    PI and project coordinator

  • Clara Pons

    Predoctoral Fellow

  • Elena Marbán

    Predoctoral FelloW

  • Azucena Bardají

    Assistant Research Professor

  • Raquel González

    Assistant Research ProfessoR

  • Laura Garcia

    Medical Research Fellow

  • Haily Chen

    Project Assistant

  • Máximo Ramírez

    Data Manager

Other collaborators

  • Anna Goncé

    Hospital Clínic

  • Elisa Llurba

    Hospital Santa Creu i Sant Pau

  • Elena Ferriols

    Hospital del Mar

  • Maria del Mar Gil

    Hospital Universitario de Torrejón

  • Miguel Ángel Rodríguez Zambrano

    HM Puerta del Sur

  • Elisa María Sáez Cerezal

    Hospital Infanta Leonor

  • Mª Begoña Adiego Burgos

    Hospital de Alcorcón

  • Paloma Toro

    Hospital General de Segovia

Who is behind this research?

Dr. Clara Menéndez is a Research Professor, Director of the Maternal, Child and Reproductive Health Initiative and Programme at ISGlobal. She is the COVID-Preg project coordinator, funded by the Instituto de Salud Carlos III from 01/05/2020 to 01/05/2021.

ISGlobal is the fruit of an innovative alliance between the La Caixa Foundation, academic institutions and government bodies to contribute to the efforts undertaken by the international community to address challenges in global health.

Collaborators

Hospitals involved in the study:

  • SJD Barcelona Children's Hospital
  • Hospital Clínic (Barcelona)
  • Hospital Santa Creu i Sant Pau (Barcelona)
  • Hospital del Mar (Barcelona)
  • Hospital Universitario de Torrejón (Madrid)
  • HM Puerta del Sur (Madrid)
  • Hospital Infanta Leonor (Madrid)
  • Hospital de Alcorcón (Madrid)
  • Hospital General de Segovia (Segovia)