Acetylsalicylic Acid in COVID-19 (ASA-SARS)

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

SARS-CoV-2 infection in pregnancy is associated with poor maternal and perinatal outcomes. One explanation is the pregnancy-associated prothrombotic status, which may increase during infection, leading to placental and vascular complications. Administration of low-dose acetylsalicylic acid (LDASA) has shown to improve maternal and perinatal outcomes in women at high-risk of endothelial and placental complications. However, there are no data on the effect of adding LDASA to low molecular weight heparin (LMWH)-which is the standard of care- in preventing complications in SARS-CoV-2- infected pregnant women. This is a randomized, double-blinded, placebo-controlled multicentre trial including 398 SARS-CoV-2-infected pregnant women with the main objective of evaluating the efficacy of adding daily LDASA to low molecular weight heparin (LMWH) from the first or second trimester up to 36 weeks' gestation in SARS-CoV-2-infected pregnant women in reducing the incidence of adverse maternal and perinatal outcomes. Pregnant women undergoing routine first or second trimester blood tests will have a SARS-CoV-2 rapid antigen test done if they agree to participate. Women with a positive SARS-CoV-2 rapid antigen test will be further tested with a confirmatory SARS-CoV-2 PCR test. In case of being also positive for the SARS-CoV-2 PCR test, she will be randomised 1:1 to receive, additionally to LMWH for at least 10 days, daily LDASA (150 mg) or placebo, up to 36 weeks of pregnancy. Women will be followed-up for the duration of the intervention and the pregnancy outcome will be registered. The findings of this study will contribute to reduce SARS-CoV-2- related complications in a highly vulnerable group to the infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Barcelona Institute for Global Health
• Collaborators: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Hopsital Central de Maputo, Mozambique; Hospital del Mar; Hospital Universitario de Torrejón,Madrid; Hospital Universitario Infanta Leonor
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Pregnant women with a positive SARS-CoV-2 antigen test and a confirmatory positive SARS-CoV-2 PCR test.

Exclusion Criteria:

• on regular ASA administration

• on long-term non-steroidal anti-inflammatory medication

• bleeding disorders such as Von Willebrand's disease

• history of peptic ulceration

• history of hypersensitivity to ASA

• participation in another clinical trial

• inability to cooperate with the requirements of the study

• severe COVID-19 disease (with any of the following: respiratory rate > 30 breaths/min; severe respiratory distress; SpO2 ≤ 93% on room air; acute respiratory distress syndrome; sepsis with acute organ dysfunction).

• treatment resistant hyperemesis gravidarum