SARS-CoV-2 and Acetylsalicylic Acid (SARA)

Phase 3

Completed

• Conditions: SARS-CoV2 Infection; Covid19
• Interventions: Drug: Placebo; Drug: Low-dose acetylsalicylic acid

• Registration Number: NCT05073718
• Lead Sponsor: Barcelona Institute for Global Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-11
• Study Start: 2022-09-14
• Primary Completion: 2024-05-23
• Study Completion: 2024-05-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (n=200)	Placebo	-
LDASA (n=200)	Low-dose acetylsalicylic acid	-

Primary Outcome Measures

Name	Time	Method
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.	up to 37 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of all-cause admissions	up to 37 weeks	maternal
Incidence of all-cause outpatient attendances	up to 37 weeks	maternal
Incidence of preeclampsia	up to 37 weeks	maternal
Prevalence of small for gestational age	up to 37 weeks	embryo-foetal/infant
Prevalence of embryo and foetal losses (miscarriages and stillbirths)	up to 37 weeks	embryo-foetal/infant
Prevalence of SARS-CoV-2 infection and COVID-19 disease during pregnancy	up to 37 weeks	maternal
Incidence of COVID-19-related admissions	up to 37 weeks	maternal
Mean duration of symptoms-signs of COVID-19	up to 37 weeks	maternal
Frequency of congenital malformations	up to 37 weeks	embryo-foetal/infant
Proportion of adverse perinatal outcome	up to 37 weeks	embryo-foetal/infant
Neonatal morbidity	up to 37 weeks	embryo-foetal/infant
Frequency and severity of adverse events	up to 37 weeks	maternal
Incidence of maternal thromboembolic complications and placental abruption	up to 37 weeks	maternal
Maternal mortality rate	up to 37 weeks	maternal
Incidence of histological placental abnormalities in SARS-CoV-2 infected pregnant women.	up to 37 weeks	maternal
Prevalence of preterm birth (<37 weeks of gestational age)	up to 37 weeks	embryo-foetal/infant
Neonatal mortality rate	up to 37 weeks	embryo-foetal/infant

Trial Locations

Locations (4)

Hospital Sant Joan de Déu; 🇪🇸 Barcelona, Catalunya, Spain

Hospital Universitario de Torrejón; 🇪🇸 Torrejón de Ardoz, Madrid, Spain

Universidade Eduardo Mondlane; 🇲🇿 Maputo, Mozambique

Hospital del Mar; 🇪🇸 Barcelona, Catalunya, Spain