SARS-CoV-2 and Acetylsalicylic Acid (SARA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2024-05-23

Brief Summary

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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.

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Detailed Description

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Conditions

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SARS-CoV2 Infection Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized double-blind placebo-controlled multicentre clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study tablets will be identically packaged in small boxes. All study personnel, investigators and the participants will remain blinded throughout the trial.

Study Groups

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LDASA (n=200)

Group Type EXPERIMENTAL

Low-dose acetylsalicylic acid

Intervention Type 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.

Placebo (n=200)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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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.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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125mg acetylsalicylic acid

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes