SARS-CoV-2 and Acetylsalicylic Acid (SARA)

Sponsor

Barcelona Institute for Global Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05073718

Collaborator

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

400

Enrollment

Arms

17.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV2 Infection Covid19	Drug: Low-dose acetylsalicylic acid Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 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 boxes. 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 :

Sep 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LDASA (n=200)	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. Other Names: 125mg acetylsalicylic acid
Placebo Comparator: Placebo (n=200)	Drug: Placebo Placebo

Arm

Intervention/Treatment

Experimental: LDASA (n=200)

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.

Other Names:

125mg acetylsalicylic acid

Placebo Comparator: Placebo (n=200)

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

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

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
Incidence of all-cause admissions [up to 37 weeks]
maternal
Incidence of all-cause outpatient attendances [up to 37 weeks]
maternal
Mean duration of symptoms-signs of COVID-19 [up to 37 weeks]
maternal
Frequency and severity of adverse events [up to 37 weeks]
maternal
Incidence of preeclampsia [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
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
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
Neonatal mortality rate [up to 37 weeks]
embryo-foetal/infant

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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