New Study to Assess the Efficacy of Hydroxychloroquine in the Prevention and Treatment of COVID-19 in Pregnant Women
A multicentre clinical trial coordinated by ISGlobal and Hospital Clínic is being carried out with the collaboration of hospitals in Barcelona and Madrid
04.05.2020
Hospitals in Barcelona and Madrid, the two Spanish cities hit hardest by the COVID-19 epidemic to date, will participate in COVID-Preg, a clinical trial coordinated by the Barcelona Institute for Global Health (ISGlobal)—a centre supported by ”la Caixa”—and Hospital Clínic. The objective of this new study is to generate conclusive evidence on the use of hydroxychloroquine in the prevention and treatment of COVID-19 in pregnant women.
Hydroxychloroquine is one of the drugs that has raised the greatest expectations as a possible treatment for COVID-19. It is currently used to prevent and treat malaria and in the treatment of other diseases, including rheumatoid arthritis. Recent studies have suggested that it may be effective in reducing the viral load of SARS-CoV-2, the novel coronavirus that causes COVID-19, although the results are inconclusive and further research is needed.
The main objectives of COVID-Preg are to determine the effect of hydroxychloroquine on disease progression in pregnant women who test positive for COVID-19 and to assess its efficacy in preventing the infection in pregnant women who test negative.
The clinical trial will enrol more than 700 pregnant women: half will receive hydroxychloroquine for 14 days and the other half will receive a placebo. On completion of the treatment, the women will be retested for the presence of SARS-CoV-2. Routine follow-up will continue until delivery, when the newborns will be tested to rule out maternal transmission of the infection.
“As far as we know, this is the only clinical trial of hydroxychloroquine being carried out in pregnant women in Spain. It will generate valuable evidence about whether treatment with hydroxychloroquine is a safe and effective way to limit the spread of SARS-CoV-2 and reduce disease severity in this vulnerable population group,” explains the study coordinator Clara Menéndez, Director of the Maternal, Child and Reproductive Health Initiative at ISGlobal. “We also hope that the study will help to improve routine follow-up of pregnant women exposed to the virus and reduce the risk of them experiencing adverse health outcomes caused by COVID-19, both during the current epidemic and in possible future epidemics. Since COVID-19 is a global health issue, the knowledge generated by this study will be useful not only in Spain but also in other settings.”
The hospitals currently taking part in this study are as follows: Hospital Clínic, Hospital Sant Joan de Déu and Hospital de la Santa Creu i Sant Pau in Barcelona, and Hospital HM Puerta del Sur and Hospital Universitario de Torrejón in Madrid.
Laboratorios Rubió contributed to this clinical trial by donating hydroxychloroquine and placebos.
The project has a budget of €530,100 and is being funded by the Carlos III Health Institute. This trial has been registered at the ClinicalTrials.gov site with the number NCT04410562.
The leaders of this research project at the participating hospitals are María del Mar Gil and Belén Santacruz (Hospital Universitario de Torrejón), Dolores Gómez (Hospital Sant Joan de Déu), Anna Goncé (Hospital Clínic–University of Barcelona), Elisa Llurba (Hospital de la Santa Creu i Sant Pau), Clara Menéndez (ISGlobal–Hospital Clínic) and Miguel Ángel Rodríguez Zambrano (Hospital HM Puerta del Sur).
Update 06/03/2020: Recruitment Continues
In response to recent publications and media reports regarding hydroxychloroquine (HCQ) safety in COVID-19 patients, the Data and Safety Monitoring Board (DSMB) of COVID-Preg trial convened an unscheduled meeting on May 27th to survey the research landscape and review COVID-Preg data. Based on this review, the DSMB has approved the COVID-Preg Trial to continue enrollment, read the meeting letter herein. No changes were requested to the protocol. Additionally, on May 28th the Spanish Agency of Drugs (Agencia Española del Medicamentos y Productos Sanitarios, AEMPS) released a letter to recommend to evaluate the efficacy and safety of Hydroxycloroquine in Randomized Controlled Trials to generate evidenced-based knowledge. Finally, the project funding institution, the Instituto de Salud Carlos III (Spanish Ministry of Health research funds institute) also supports the trial continuity.
Related Links
An open letter to Mehra et al and The New England Journal of Medicine
The Lancet (Comment): The need for a global COVID-19 maternal immunisation research plan
