search
Back to results

SARS-CoV-2 and Acetylsalicylic Acid (SARA) (SARA)

Primary Purpose

SARS-CoV2 Infection, Covid19

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Low-dose acetylsalicylic acid
Placebo
Sponsored by
Barcelona Institute for Global Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS-CoV2 Infection focused on measuring SARS-COV2, Acetylsalicylic acid, Asprin, ASA, COVID-19, Perinatal, Pregnancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universidade Eduardo MondlaneRecruiting
  • Hospital del MarRecruiting
  • Hospital Sant Joan de DéuRecruiting
  • Hospital Universitario de TorrejónRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LDASA (n=200)

Placebo (n=200)

Arm Description

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 15, 2021
Last Updated
February 28, 2023
Sponsor
Barcelona Institute for Global Health
Collaborators
Hospital Universitario de Torrejón, Hospital Universitario Infanta Leonor, Hospital Sant Joan de Deu, Hospital del Mar, Eduardo Mondlane University, Hospital Central de Maputo, Hospital Geral de Mavalane, Hospital Geral José Macamo
search

1. Study Identification

Unique Protocol Identification Number
NCT05073718
Brief Title
SARS-CoV-2 and Acetylsalicylic Acid (SARA)
Acronym
SARA
Official Title
Efficacy of Low Dose Acetylsalicylic Acid in Preventing Adverse Maternal and Perinatal Outcomes in SARS-CoV-2 Infected Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barcelona Institute for Global Health
Collaborators
Hospital Universitario de Torrejón, Hospital Universitario Infanta Leonor, Hospital Sant Joan de Deu, Hospital del Mar, Eduardo Mondlane University, Hospital Central de Maputo, Hospital Geral de Mavalane, Hospital Geral José Macamo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV2 Infection, Covid19
Keywords
SARS-COV2, Acetylsalicylic acid, Asprin, ASA, COVID-19, Perinatal, Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized double-blind placebo-controlled multicentre clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LDASA (n=200)
Arm Type
Experimental
Arm Title
Placebo (n=200)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Low-dose acetylsalicylic acid
Other Intervention Name(s)
125mg acetylsalicylic acid
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Prevalence of SARS-CoV-2 infection and COVID-19 disease during pregnancy
Description
maternal
Time Frame
up to 37 weeks
Title
Incidence of COVID-19-related admissions
Description
maternal
Time Frame
up to 37 weeks
Title
Incidence of all-cause admissions
Description
maternal
Time Frame
up to 37 weeks
Title
Incidence of all-cause outpatient attendances
Description
maternal
Time Frame
up to 37 weeks
Title
Mean duration of symptoms-signs of COVID-19
Description
maternal
Time Frame
up to 37 weeks
Title
Frequency and severity of adverse events
Description
maternal
Time Frame
up to 37 weeks
Title
Incidence of preeclampsia
Description
maternal
Time Frame
up to 37 weeks
Title
Incidence of maternal thromboembolic complications and placental abruption
Description
maternal
Time Frame
up to 37 weeks
Title
Maternal mortality rate
Description
maternal
Time Frame
up to 37 weeks
Title
Incidence of histological placental abnormalities in SARS-CoV-2 infected pregnant women.
Description
maternal
Time Frame
up to 37 weeks
Title
Prevalence of preterm birth (<37 weeks of gestational age)
Description
embryo-foetal/infant
Time Frame
up to 37 weeks
Title
Prevalence of small for gestational age
Description
embryo-foetal/infant
Time Frame
up to 37 weeks
Title
Prevalence of embryo and foetal losses (miscarriages and stillbirths)
Description
embryo-foetal/infant
Time Frame
up to 37 weeks
Title
Frequency of congenital malformations
Description
embryo-foetal/infant
Time Frame
up to 37 weeks
Title
Proportion of adverse perinatal outcome
Description
embryo-foetal/infant
Time Frame
up to 37 weeks
Title
Neonatal morbidity
Description
embryo-foetal/infant
Time Frame
up to 37 weeks
Title
Neonatal mortality rate
Description
embryo-foetal/infant
Time Frame
up to 37 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Candelaria Serrano, Dr.
Phone
+34 691642368
Email
candelaria.serrano@isglobal.org
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Stoeger, MSc
Email
linda.stoeger@isglobal.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clara Menéndez, Dr.
Organizational Affiliation
Barcelona Institute for Global Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Eduardo Mondlane
City
Maputo
ZIP/Postal Code
257
Country
Mozambique
Individual Site Status
Recruiting
Facility Name
Hospital del Mar
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Sant Joan de Déu
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Torrejón
City
Torrejón de Ardoz
State/Province
Madrid
ZIP/Postal Code
28850
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

SARS-CoV-2 and Acetylsalicylic Acid (SARA)

We'll reach out to this number within 24 hrs