NCT05073718.

Study name	ASA‐SARS / NCT05073718
Methods	Trial design: multicentre, double‐blind, placebo‐controlled RCT Type of publication: trial registry Recruitment dates: not yet recruiting Country: Spain Language: English Number of centres: multicentre Inclusion criteria: pregnant women with a positive SARS‐CoV‐2 antigen test and a confirmatory positive SARS‐CoV‐2 PCR test Exclusion criteria: on regular ASA administration, on long‐term non‐steroidal anti‐inflammatory medication, bleeding disorders, history of peptic ulceration, history of hypersensitivity to ASA, participation in another clinical trial, inability to co‐operate 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) Trial registration number: NCT05073718 Date of trial registration: 11 October 2021 Prospective completion date: October 2023
Participants	Age: aged 18 years or older Gender: female Ethnicity: NR Number of participants (recruited/allocated/evaluated): 398 planned Severity of disease: positive SARS‐CoV‐2 antigen test and a confirmatory positive SARS‐CoV‐2 PCR test, severe cases excluded Additional diagnoses: NR
Interventions	Low‐dose acetylsalicylic acid (LDASA, 150 mg daily) from the first or second trimester up to 36 weeks gestation and prophylactic doses of low molecular weight heparin Placebo from the first or second trimester up to 36 weeks gestation and prophylactic doses of low molecular weight heparin Concomitant therapy: NR Treatment cross‐overs: NR Duration of follow‐up: NR Compliance with assigned treatment: NR
Outcomes	Primary outcomes (time frame: up to 37 weeks) Rate of composite adverse maternal and perinatal adverse outcome including foetal death, preterm pre‐eclampsia, maternal thromboembolic complications, placental abruption, preterm birth and small for gestational age Secondary outcomes (time frame: up to 37 weeks) Prevalence of SARS‐CoV‐2 infection and COVID‐19 disease during pregnancy Incidence of COVID‐19‐related admissions Incidence of all‐cause admissions Incidence of all‐cause outpatients attendances Mean duration of symptom‐sings of COVID‐19 Frequency and severity of adverse events Incidence of preeclampsia Incidence of maternal thromboembolic complications and placental abruption Maternal mortality rate Incidence of histological placental abnormalities in SARS‐CoV‐2 infected pregnant women Prevalence of preterm birth (< 37 weeks of gestation age) Prevalence of small for gestational age Prevalence of embryo and foetal losses (miscarriages and stillbirths) Proportion of adverse perinatal outcome Neonatal morbidity Neonatal mortality rate Additional outcomes: NR
Starting date	Estimated start date: 15 January 2022
Contact information	Laura Garcia, Dr. +34932275400, laura.garcia@isglobal.org
Notes	Sponsor/collaborators: Barcelona Institute for Global Health, Hospital Universitario de Torrejon Madrid, Hospital Universitario Infanta Leonor, Fundacio Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital del Mar, Hospital Central de Maputo Mozambique