SARS-CoV2 InfectionPhase 3SARANCT05073718
SARS-CoV-2 and Acetylsalicylic Acid (SARA)
A Phase 3 study testing Low-dose acetylsalicylic acid in people with SARS-CoV2 Infection and Covid19, run by Barcelona Institute for Global Health at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection, Covid19
- What is being tested?
- Low-dose acetylsalicylic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 Sep 2022to 23 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Spain3 sites
Hospital del Mar
Barcelona, Catalonia, 08003
Hospital Sant Joan de Déu
Barcelona, Catalonia, 08950
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid, 28850
About this study
Official title: Efficacy of Low Dose Acetylsalicylic Acid in Preventing Adverse Maternal and Perinatal Outcomes in SARS-CoV-2 Infected Pregnant Women
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
- Being tested
- Low-dose acetylsalicylic acid, Placebo
- Keywords
- SARS-COV2, Acetylsalicylic acid, Asprin, ASA, COVID-19, Perinatal, Pregnancy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose acetylsalicylic acidDrug
Also called 125mg 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.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| LDASA (n=200) | Experimental | Not described Receives: Drug: Low-dose acetylsalicylic acid |
| Placebo (n=200) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 37 weeks
Secondary outcomes (17)
Prevalence of SARS-CoV-2 infection and COVID-19 disease during pregnancy
maternal
Measured: up to 37 weeks
Incidence of COVID-19-related admissions
maternal
Measured: up to 37 weeks
Incidence of all-cause admissions
maternal
Measured: up to 37 weeks
Incidence of all-cause outpatient attendances
maternal
Measured: up to 37 weeks
Mean duration of symptoms-signs of COVID-19
maternal
Measured: up to 37 weeks
Frequency and severity of adverse events
maternal
Measured: up to 37 weeks
Incidence of preeclampsia
maternal
Measured: up to 37 weeks
Incidence of maternal thromboembolic complications and placental abruption
maternal
Measured: up to 37 weeks
Maternal mortality rate
maternal
Measured: up to 37 weeks
Incidence of histological placental abnormalities in SARS-CoV-2 infected pregnant women.
maternal
Measured: up to 37 weeks
Prevalence of preterm birth (<37 weeks of gestational age)
embryo-foetal/infant
Measured: up to 37 weeks
Prevalence of small for gestational age
embryo-foetal/infant
Measured: up to 37 weeks
Prevalence of embryo and foetal losses (miscarriages and stillbirths)
embryo-foetal/infant
Measured: up to 37 weeks
Frequency of congenital malformations
embryo-foetal/infant
Measured: up to 37 weeks
Proportion of adverse perinatal outcome
embryo-foetal/infant
Measured: up to 37 weeks
Neonatal morbidity
embryo-foetal/infant
Measured: up to 37 weeks
Neonatal mortality rate
embryo-foetal/infant
Measured: up to 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start14 Sep 2022
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blind placebo-controlled multicentre clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona Institute for Global Health
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de Torrejón, Madrid, 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
- Responsible party
- Sponsor
- Investigators
- Clara Menéndez, Dr., Principal investigator, Barcelona Institute for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073718
- Sponsor's protocol ID
- 2022-000535-23
- Acronym
- SARA
- Status last verified
- Aug 2024
- First submitted
- 15 Sep 2021
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37489818
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low Dose Acetylsalicylic Acid in Preventing Adverse Maternal and Perinatal Outcomes in SARS-CoV-2 Infected Pregnant Women
- ClinicalTrials.gov ID
- NCT05073718
- Acronym / sponsor ID
- SARA / 2022-000535-23
- Conditions
- SARS-CoV2 Infection, Covid19
- Keywords
- SARS-COV2, Acetylsalicylic acid, Asprin, ASA, COVID-19, Perinatal, Pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Barcelona Institute for Global HealthUniversity, hospital or other
- Collaborators
- Hospital Universitario de Torrejón, Madrid, 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
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blind placebo-controlled multicentre clinical trial
| Arm | Type | Receives |
|---|---|---|
| LDASA (n=200) | Experimental | Drug: Low-dose acetylsalicylic acid |
| Placebo (n=200) | Placebo comparator | Drug: Placebo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women up to 32 weeks of gestational age
- Aged 18 years or older*
- Willing to deliver at the recruitment health facilities
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose acetylsalicylic acidAlso: 125mg acetylsalicylic acidIn 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. | Drug | LDASA (n=200) |
| PlaceboPlacebo | Drug | Placebo (n=200) |
Primary outcome
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
17 secondary outcomes
Prevalence of SARS-CoV-2 infection and COVID-19 disease during pregnancy
Time frame: up to 37 weeks
Incidence of COVID-19-related admissions
Time frame: up to 37 weeks
Incidence of all-cause admissions
Time frame: up to 37 weeks
Incidence of all-cause outpatient attendances
Time frame: up to 37 weeks
Mean duration of symptoms-signs of COVID-19
Time frame: up to 37 weeks
Frequency and severity of adverse events
Time frame: up to 37 weeks
Incidence of preeclampsia
Time frame: up to 37 weeks
Incidence of maternal thromboembolic complications and placental abruption
Time frame: up to 37 weeks
Maternal mortality rate
Time frame: up to 37 weeks
Incidence of histological placental abnormalities in SARS-CoV-2 infected pregnant women.
Time frame: up to 37 weeks
Prevalence of preterm birth (<37 weeks of gestational age)
Time frame: up to 37 weeks
Prevalence of small for gestational age
Time frame: up to 37 weeks
Prevalence of embryo and foetal losses (miscarriages and stillbirths)
Time frame: up to 37 weeks
Frequency of congenital malformations
Time frame: up to 37 weeks
Proportion of adverse perinatal outcome
Time frame: up to 37 weeks
Neonatal morbidity
Time frame: up to 37 weeks
Neonatal mortality rate
Time frame: up to 37 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Derived from this study: PubMed 37489818Fischer 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.
Related trials for SARS-CoV2 Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara Menéndez, Dr. principal investigator
Barcelona Institute for Global Health
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low-dose acetylsalicylic acid in people with SARS-CoV2 Infection and Covid19, run by Barcelona Institute for Global Health at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: up to 37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05073718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.