SARS-CoV-2 and Acetylsalicylic Acid (SARA)

Covid19 Clinical Trial

— SARA  

Official title:

Efficacy of Low Dose Acetylsalicylic Acid in Preventing Adverse Maternal and Perinatal Outcomes in SARS-CoV-2 Infected Pregnant Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05073718
• Other study ID #: 2022-000535-23
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 14, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Barcelona Institute for Global Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: June 30, 2024
• Est. primary completion date: June 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV2 Infection

Intervention

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.
• Placebo
Placebo

Locations

Country	Name	City	State
Mozambique	Universidade Eduardo Mondlane	Maputo
Spain	Hospital del Mar	Barcelona	Catalunya
Spain	Hospital Sant Joan de Déu	Barcelona	Catalunya
Spain	Hospital Universitario de Torrejón	Torrejón de Ardoz	Madrid

Sponsors (9)

Lead Sponsor	Collaborator
Barcelona Institute for Global Health	Eduardo Mondlane University, Hospital Central de Maputo, Hospital del Mar, Hospital Geral de Mavalane, Hospital Geral José Macamo, Hospital Sant Joan de Deu, Hospital Universitario de Torrejón, Hospital Universitario Infanta Leonor

Countries where clinical trial is conducted

Mozambique,  Spain, 

Outcome

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