SARA Project Kicks Off with the Aim of Evaluating the Efficacy and Safety of Acetylsalicylic Acid in the Prevention of Complications Due to COVID-19 in Pregnancy

The SARA (SARS-CoV-2 and Acetylsalicylic acid) study, led by ISGlobal researchers, has been launched to assess the efficacy and safety of low-dose acetylsalicylic acid (LDASA) administration in pregnant women infected with SARS-CoV-2, to reduce the incidence of adverse maternal and perinatal outcomes. Patient recruitment for the trial began in September 2022 in Maputo and will be conducted in Barcelona and Madrid in October 2022. 

COVID-19 infection in pregnancy is associated with an increased risk of adverse outcomes such as miscarriage, stillbirth and maternal thromboembolic complications. One explanation is that the infection might increase the existing pregnancy-associated prothrombotic status, leading to a higher risk of placental and vascular complications.

Although administration of low-dose acetylsalicylic acid (LDASA) has been shown to improve outcomes in women at high risk of endothelial and placental complications, as of now, there is no evidence on the effect of LDASA in preventing complications in pregnant women infected with SARS-CoV-2.

For this purpose, the SARA study, a randomised, double-blinded, placebo-controlled, multicentre trial involving 400 pregnant women, has been launched. Women who have tested positive for SARS-CoV-2 in the seven days prior to the trial or who test positive in the screening test established in the study health centres will be randomly assigned to receive a daily dose of LDASA or its placebo until 36 weeks of gestation.

The study is being conducted in Spain - at the maternity centres of Hospital Sant Joan de Déu and Hospital del Mar in Barcelona and Hospital Universitario de Torrejón in Madrid - and in Mozambique at Mavalane Hospital and José Macamo Hospital in Maputo.

"The results in different settings will allow conclusions to be drawn that can be extrapolated to low- and middle-income countries affected by COVID-19," explains the research team, led by Clara Menéndez, director of ISGlobal's Maternal, Child and Reproductive Health programme.

The trial, which is funded by La Marató de TV3, will follow the participants up to the moment of delivery. Participants will be interviewed at 16, 28 and 36 weeks of gestation, 5-10 days after completing treatment and after delivery to assess general health, tolerability and possible adverse effects of the drug, adherence to treatment, and maternal and perinatal outcomes.