Clinical trial NCT05073718: SARS-CoV-2 and Acetylsalicylic Acid (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
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV2 Infection
Covid19
Keywords: SARS-COV2
Acetylsalicylic acid
Asprin
ASA
COVID-19
Perinatal
Pregnancy
Lead sponsor: Barcelona Institute for Global Health
Sponsor class: OTHER
Collaborators: name: Hospital Universitario de Torrejón
name: Hospital Universitario Infanta Leonor
name: Hospital Sant Joan de Deu
name: Hospital del Mar
name: Eduardo Mondlane University
name: Hospital Central de Maputo
name: Hospital Geral de Mavalane
name: Hospital Geral José Macamo
First posted: 2021-10-11
Enrollment: 38
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blind placebo-controlled multicentre clinical trial
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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.
timeFrame: up to 37 weeks
Secondary outcomes:
measure: Prevalence of SARS-CoV-2 infection and COVID-19 disease during pregnancy
timeFrame: up to 37 weeks
measure: Incidence of COVID-19-related admissions
timeFrame: up to 37 weeks
measure: Incidence of all-cause admissions
timeFrame: up to 37 weeks
measure: Incidence of all-cause outpatient attendances
timeFrame: up to 37 weeks
measure: Mean duration of symptoms-signs of COVID-19
timeFrame: up to 37 weeks
measure: Frequency and severity of adverse events
timeFrame: up to 37 weeks
measure: Incidence of preeclampsia
timeFrame: up to 37 weeks
measure: Incidence of maternal thromboembolic complications and placental abruption
timeFrame: up to 37 weeks
measure: Maternal mortality rate
timeFrame: up to 37 weeks
measure: Incidence of histological placental abnormalities in SARS-CoV-2 infected pregnant women.
timeFrame: up to 37 weeks
measure: Prevalence of preterm birth (<37 weeks of gestational age)
timeFrame: up to 37 weeks
measure: Prevalence of small for gestational age
timeFrame: up to 37 weeks
measure: Prevalence of embryo and foetal losses (miscarriages and stillbirths)
timeFrame: up to 37 weeks
measure: Frequency of congenital malformations
timeFrame: up to 37 weeks
measure: Proportion of adverse perinatal outcome
timeFrame: up to 37 weeks
measure: Neonatal morbidity
timeFrame: up to 37 weeks
measure: Neonatal mortality rate
timeFrame: up to 37 weeks
Other outcomes:
Locations:
city: Maputo
country: Mozambique
facility: Universidade Eduardo Mondlane
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Catalunya
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu
state: Catalunya
city: Torrejón de Ardoz
country: Spain
facility: Hospital Universitario de Torrejón
state: Madrid
Study officials:
affiliation: Barcelona Institute for Global Health
name: Clara Menéndez, Dr.
role: PRINCIPAL_INVESTIGATOR
References: