SARS-CoV-2 and Acetylsalicylic Acid (SARA)

NCT05073718 | Completed Phase 3 DMC

• 1 other identifier: 2022-000535-23
• Study Type: interventional
• Target: 38
• Locations: 2 countries
• Sites: 4

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.

Conditions

SARS-CoV2 Infection; Covid19

Keywords

SARS-COV2; Acetylsalicylic acid; Asprin; ASA; COVID-19; Perinatal; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Prevalence of SARS-CoV-2 infection and COVID-19 disease during pregnancy

  up to 37 weeks

• Incidence of COVID-19-related admissions

  up to 37 weeks

• Incidence of all-cause admissions

  up to 37 weeks

• Incidence of all-cause outpatient attendances

  up to 37 weeks

• Mean duration of symptoms-signs of COVID-19

  up to 37 weeks

Study Arms (2)

LDASA (n=200)

EXPERIMENTAL

Drug: Low-dose acetylsalicylic acid

Placebo (n=200)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Low-dose acetylsalicylic acid 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.

Also known as: 125mg acetylsalicylic acid

LDASA (n=200)

Placebo DRUG

Placebo

Placebo (n=200)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Barcelona Institute for Global Health: lead
• Hospital Universitario de Torrejón: collaborator
• Hospital Universitario Infanta Leonor: collaborator
• Hospital Sant Joan de Deu: collaborator
• Hospital del Mar: collaborator
• Eduardo Mondlane University: collaborator
• Hospital Central de Maputo: collaborator
• Hospital Geral de Mavalane: collaborator
• Hospital Geral José Macamo: collaborator

Study Sites (4)

Universidade Eduardo Mondlane

Maputo, 257, Mozambique

Location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

Hospital Sant Joan de Déu

Barcelona, Catalonia, 08950, Spain

Location

Hospital Universitario de Torrejón

Torrejón de Ardoz, Madrid, 28850, Spain

Location

Related Publications (1)

• Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.

  PMID: 37489818 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Clara Menéndez, Dr.

  Barcelona Institute for Global Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study tablets will be identically packaged in small boxes. All study personnel, investigators and the participants will remain blinded throughout the trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double-blind placebo-controlled multicentre clinical trial

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 11, 2021
• Study Start: September 14, 2022
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

MO (1); ES (3)