Skip to main content
OpenTrials
Completed

NCT Number: NCT05073718

SARS-CoV-2 and Acetylsalicylic Acid (SARA)

SARS-CoV-2 infection in pregnancy is associated with an increased risk of adverse maternal and perinatal outcomes. One explanation is that the infection might increase the existing pregnancy-associated prothrombotic status, leading to a higher risk of 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 LDASA in preventing complications in SARS-CoV-2- infected pregnant women. To reduce SARS-CoV-2- related complications in a highly vulnerable group to the infection, we will carry out this randomized, double-blind, placebo-controlled multicentre trial in 400 SARS-CoV-2-infected pregnant women. The study main objective is to evaluate the efficacy and safety of LDASA administered up to 36 weeks of gestation in SARS-CoV-2-infected pregnant women in reducing the incidence of adverse maternal and perinatal outcomes. Pregnant women tested positive up to 32 weeks of gestation with a SARS-CoV-2 rapid antigen or PCR test and agreeing to participate, will be randomised 1:1 to receive daily LDASA (125 mg) or placebo up to 36 weeks of gestation and be followed-up until delivery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

SARS-CoV2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Universidade Eduardo Mondlane, Maputo, Mozambique

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women up to 32 weeks of gestational age
  • Aged 18 years or older*
  • Willing to deliver at the recruitment health facilities
  • In Mozambique, in case of age below 18 years, the participant will be asked for the assent and the informed consent will be given by the legal tutor in accordance with the national regulations.

Exclusion criteria

  • On regular ASA treatment for pre-eclampsia prevention
  • On long-term non-steroidal anti-inflammatory medication
  • Bleeding disorders, mainly haemophilia, hypoprothrombinaemia orVon Willebrand's disease
  • History of hypersensitivity to ASA or to any of the excipients of the investigational product.
  • History of peptic ulceration, including active, chronic or recurrent gastroduodenal ulcer; recurrent gastric discomfort History of gastric bleeding or perforation after treatment with aspirin or other non-steroidal anti-inflammatory drugs
  • 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
  • Hypersensitivity to nonsteroidal anti-inflammatory drugs or to tartrazine (cross-reaction) or to any of the excipients used in its composition.
  • Asthma.
  • Severe renal or hepatic insufficiency.
  • Nasal polyps associated with asthma that are induced or exacerbated by aspirin.
  • 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

Treatment and study plan

Low-dose acetylsalicylic acid

Drug

In case of being positive for SARS-CoV-2 PCR or antigen test, she will be randomised 1:1 to receive daily LDASA (125 mg) or placebo, up to 36 weeks of pregnancy.

Other names: 125mg acetylsalicylic acid

Placebo

Drug

Placebo

Primary outcomes

  1. Rate of composite adverse maternal and perinatal adverse outcomes including miscarriage, foetal death, preeclampsia, maternal thromboembolic complications, placental abruption, preterm birth and small for gestational age.

    Time frame: up to 37 weeks

Secondary outcomes

  1. Prevalence of SARS-CoV-2 infection and COVID-19 disease during pregnancy

    Time frame: up to 37 weeks

    maternal

  2. Incidence of COVID-19-related admissions

    Time frame: up to 37 weeks

    maternal

  3. Incidence of all-cause admissions

    Time frame: up to 37 weeks

    maternal

  4. Incidence of all-cause outpatient attendances

    Time frame: up to 37 weeks

    maternal

  5. Mean duration of symptoms-signs of COVID-19

    Time frame: up to 37 weeks

    maternal

  6. Frequency and severity of adverse events

    Time frame: up to 37 weeks

    maternal

  7. Incidence of preeclampsia

    Time frame: up to 37 weeks

    maternal

  8. Incidence of maternal thromboembolic complications and placental abruption

    Time frame: up to 37 weeks

    maternal

  9. Maternal mortality rate

    Time frame: up to 37 weeks

    maternal

  10. Incidence of histological placental abnormalities in SARS-CoV-2 infected pregnant women.

    Time frame: up to 37 weeks

    maternal

  11. Prevalence of preterm birth (<37 weeks of gestational age)

    Time frame: up to 37 weeks

    embryo-foetal/infant

  12. Prevalence of small for gestational age

    Time frame: up to 37 weeks

    embryo-foetal/infant

  13. Prevalence of embryo and foetal losses (miscarriages and stillbirths)

    Time frame: up to 37 weeks

    embryo-foetal/infant

  14. Frequency of congenital malformations

    Time frame: up to 37 weeks

    embryo-foetal/infant

  15. Proportion of adverse perinatal outcome

    Time frame: up to 37 weeks

    embryo-foetal/infant

  16. Neonatal morbidity

    Time frame: up to 37 weeks

    embryo-foetal/infant

  17. Neonatal mortality rate

    Time frame: up to 37 weeks

    embryo-foetal/infant

Sponsors and collaborators

Lead sponsor

Barcelona Institute for Global Health

Other

Collaborators

  • Eduardo Mondlane University
  • Hospital Central de Maputo
  • Hospital Geral José Macamo
  • Hospital Geral de Mavalane
  • Hospital Sant Joan de Deu
  • Hospital Universitario Infanta Leonor
  • Hospital Universitario de Torrejón
  • Hospital del Mar

Registry information

Official study title

Efficacy of Low Dose Acetylsalicylic Acid in Preventing Adverse Maternal and Perinatal Outcomes in SARS-CoV-2 Infected Pregnant Women

Acronym: SARA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 11, 2021
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.