Acetylsalicylic Acid in COVID-19 (ASA-SARS)
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.
Arms and Interventions
|Experimental: LDASA + prophylactic doses of LMWH (n=199)|
Drug: Low-dose acetylsalicylic acid
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.
|Placebo Comparator: Placebo + prophylactic doses of LMWH (n=199)|
Primary Outcome Measures
- Rate of composite adverse maternal and perinatal adverse outcome including fetal death, preterm preeclampsia, maternal thromboembolic complications, placental abruption, preterm birth and small for gestational age. [up to 37 weeks]
Secondary Outcome Measures
- Prevalence of SARS-CoV-2 infection and COVID-19 disease during pregnancy [up to 37 weeks]
- Incidence of COVID-19-related admissions [up to 37 weeks]
- Incidence of all-cause admissions [up to 37 weeks]
- Incidence of all-cause outpatient attendances [up to 37 weeks]
- Mean duration of symptoms-signs of COVID-19 [up to 37 weeks]
- Frequency and severity of adverse events [up to 37 weeks]
- Incidence of preeclampsia [up to 37 weeks]
- Incidence of maternal thromboembolic complications and placental abruption [up to 37 weeks]
- Maternal mortality rate [up to 37 weeks]
- Incidence of histological placental abnormalities in SARS-CoV-2 infected pregnant women. [up to 37 weeks]
- Prevalence of preterm birth (<37 weeks of gestational age) [up to 37 weeks]
- Prevalence of small for gestational age [up to 37 weeks]
- Prevalence of embryo and foetal losses (miscarriages and stillbirths) [up to 37 weeks]
- Proportion of adverse perinatal outcome [up to 37 weeks]
- Neonatal morbidity [up to 37 weeks]
- Neonatal mortality rate [up to 37 weeks]
- Pregnant women with a positive SARS-CoV-2 antigen test and a confirmatory positive SARS-CoV-2 PCR test.
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
Contacts and Locations
LocationsNo locations specified.
Sponsors and Collaborators
- Barcelona Institute for Global Health
- Hospital Universitario de Torrejón,Madrid
- Hospital Universitario Infanta Leonor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Hospital del Mar
- Hopsital Central de Maputo, Mozambique
Study Documents (Full-Text)None provided.