Acetylsalicylic Acid in COVID-19 (ASA-SARS)

Sponsor
Barcelona Institute for Global Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05073718
Collaborator
Hospital Universitario de Torrejón,Madrid (Other), Hospital Universitario Infanta Leonor (Other), Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other), Hospital del Mar (Other), Hopsital Central de Maputo, Mozambique (Other)
199
Enrollment
2
Arms
24
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Low-dose acetylsalicylic acid
  • Drug: Placebo
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
199 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized double-blind placebo-controlled multicentre clinical trialRandomized double-blind placebo-controlled multicentre clinical trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Study tablets will be identically packaged in small opaque bottles. All study personnel, investigators and the participants will remain blinded throughout the trial.
Primary Purpose:
Prevention
Official Title:
Efficacy of Low Dose Acetylsalicylic Acid in Preventing Adverse Maternal and Perinatal Outcomes in SARS-CoV-2 Infected Pregnant Women
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

ArmIntervention/Treatment
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.
Other Names:
  • Asprin
  • Placebo Comparator: Placebo + prophylactic doses of LMWH (n=199)

    Drug: Placebo
    Placebo

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Prevalence of SARS-CoV-2 infection and COVID-19 disease during pregnancy [up to 37 weeks]

    2. Incidence of COVID-19-related admissions [up to 37 weeks]

    3. Incidence of all-cause admissions [up to 37 weeks]

    4. Incidence of all-cause outpatient attendances [up to 37 weeks]

    5. Mean duration of symptoms-signs of COVID-19 [up to 37 weeks]

    6. Frequency and severity of adverse events [up to 37 weeks]

    7. Incidence of preeclampsia [up to 37 weeks]

    8. Incidence of maternal thromboembolic complications and placental abruption [up to 37 weeks]

    9. Maternal mortality rate [up to 37 weeks]

    10. Incidence of histological placental abnormalities in SARS-CoV-2 infected pregnant women. [up to 37 weeks]

    11. Prevalence of preterm birth (<37 weeks of gestational age) [up to 37 weeks]

    12. Prevalence of small for gestational age [up to 37 weeks]

    13. Prevalence of embryo and foetal losses (miscarriages and stillbirths) [up to 37 weeks]

    14. Proportion of adverse perinatal outcome [up to 37 weeks]

    15. Neonatal morbidity [up to 37 weeks]

    16. Neonatal mortality rate [up to 37 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No 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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Barcelona Institute for Global Health
    ClinicalTrials.gov Identifier:
    NCT05073718
    Other Study ID Numbers:
    • HCB/2021/0060
    First Posted:
    Oct 11, 2021
    Last Update Posted:
    Oct 11, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Barcelona Institute for Global Health
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 11, 2021