SARS-CoV-2 and Acetylsalicylic Acid (SARA)

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.

Conditions

• SARS-CoV2 Infection
• Covid19

Interventions

DRUG

Low-dose acetylsalicylic acid

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.

DRUG

Placebo

Placebo

Sponsors & Collaborators

• Hospital Universitario de Torrejón

  collaborator UNKNOWN

• Hospital Universitario Infanta Leonor

  collaborator OTHER

• Hospital Sant Joan de Deu

  collaborator OTHER

• Hospital del Mar

  collaborator OTHER

• Eduardo Mondlane University

  collaborator OTHER

• Hospital Central de Maputo

  collaborator UNKNOWN

• Hospital Geral de Mavalane

  collaborator UNKNOWN

• Hospital Geral José Macamo

  collaborator UNKNOWN

• Barcelona Institute for Global Health

  lead OTHER

Principal Investigators

• Clara Menéndez, Dr. · Barcelona Institute for Global Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-14

Primary Completion

2024-05-23

Completion

2024-05-23

Countries

• Mozambique
• Spain

Study Locations