PregnancyO-STEREONCT05847140
A Non-interventional Multi-country Cohort Study to Assess the Safety of EVUSHELD™ During Pregnancy
An observational study of Pregnancy and Pregnant Women, run by AstraZeneca.
Trial summary
Multi-country, non-interventional cohort study.The objective of the study is to characterise the risk of pregnancy and offspring (neonatal and infant) outcomes in pregnancies with and without exposure to EVUSHELD (used as a treatment or prophylaxis) among women of child-bearing indicated for such treatment in the… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Pregnancy, Pregnant Women, Pregnancy Outcome
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2022to 31 Jan 2024
- Phase
- Observational
- 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 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: The study will include pregnancies in individuals eligible for EVUSHELD administration in each country, including pregnant females aged 18-49 years with a high-risk condition. Exposed and unexposed pregnancies will be identified from this population for outcome-specific analyses. EVUSHELD indication varies from one country to another and may evolve over the course of the study. In order to have a homogeneous study population and maximise its size, all countryspecific EVUSHELD eligibility criteria at the time of protocol development were considered to define the study population.
Who may be able to join
- Female sex at LMP
- Age 18-49 years at LMP
- Continuous coverage/clinical activity (dependent on data source type) within the confounder ascertainment period
- LMP date falls within the LMP eligibility period
- Occurrence of at least one of the following high-risk conditions during the confounder ascertainment period
- Immunocompromised conditions:
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- Cancer (active solid cancer, blood cancer, or receipt of chemotherapy, immunotherapy, or radiotherapy)
- Solid organ transplant
- HIV/AIDS
- Prolonged systemic corticosteroid use (15-20 mg of prednisone equivalents for greater than 2 weeks)
- Receipt of T or B cell depleting therapy, anti-Tumour Necrosis Factor (anti- TNF), or other immunosuppressive agents
- Receipt of stem cell transplant
- Receipt of gene cell therapy of the CAR-T cell type
- Congenital immunodeficiency, primary immune deficiencies (treatment with subcutaneous or intravenous immunoglobulins - and/or immunodeficiency diagnosis codes), severe or combined immunodeficiency (including transplanted
- Severe combined immunodeficiency [SCID] where immunoglobulin replacement is required)
- Other autoimmune conditions and immune-mediated inflammatory disorders (such as systemic lupus erythematosus, Crohn's disease, ulcerative colitis).
- Conditions that increase risk of COVID-19 disease progression
- Severe risk of COVID-19 disease progression: sickle cell disease, chronic lung disease (ie, chronic bronchitis, Chronic obstructive pulmonary disease [COPD], cystic fibrosis, emphysema with dyspnoea on exertion), chronic kidney disease, cardiovascular diseases (ie, heart failure, coronary artery disease, cardiomyopathies), moderate to severe asthma, Down syndrome, rare neurological conditions (ie, multiple sclerosis, motor neurone disease, myasthenia gravis, Huntington's disease), gestational diabetes requiring medication
- Moderate risk of COVID-19 disease progression: type I or II diabetes, obesity, chronic liver disease, congenital heart disease
Who cannot join
- Multifoetal pregnancies are defined by the presence of any International Classification of Diseases (ICD-10) diagnosis code, any position indicating presence of more than one foetus (see code list) on the hospital record throughout the pregnancy episode
- Use of in vitro fertilisation or other assisted reproductive technology in the 36 weeks prior LMP as identified by ICD-10 diagnosis code "pregnancy resulting from assisted reproductive technology" or related procedure codes indicating in vitro fertilisation (IVF) or assisted reproductive technology (ART) (see code list) on the electronic health records (EHR) or hospital claims records 36 weeks prior to LMP
About this study
Official title: A Non-interventional Multi-country Cohort Study to Assess the Safety of EVUSHELD™ (Tixagevimab/Cilgavimab) During Pregnancy
Multi-country, non-interventional cohort study.The objective of the study is to characterise the risk of pregnancy and offspring (neonatal and infant) outcomes in pregnancies with and without exposure to EVUSHELD (used as a treatment or prophylaxis) among women of child-bearing indicated for such treatment in the real-world setting, using secondary data from US, France and Canada.
Read the detailed description
This is a multi-country, non-interventional cohort study in pregnancies exposed to EVUSHELD and pregnancies unexposed to EVUSHELD among women eligible for EVUSHELD. The study will be conducted within secondary data sources (administrative claims, electronic medical records (EMR) and/or registry data). For each country, the overall study period will span 12 months prior to the country-specific EVUSHELD availability until the end of the data cut or 31 March 2027, whichever is earlier.
The study will include pregnancies in individuals eligible for EVUSHELD therapy in each country in the selected datasets, including pregnant individuals aged 18 to 49 years with a high-risk condition documented in the 12 months prior to the start of the pregnancy, defined as the first day of the last menstrual period (LMP).
- Conditions
- Pregnancy, Pregnant Women, Pregnancy Outcome
- Keywords
- Pregnancy outcome, evusheld, pregnancy exposure, immunocompromised condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Evusheld exposed pregnancies | A pregnancy is considered exposed to EVUSHELD if 1 of 2 conditions are met: (1) EVUSHELD was received during the 36-week period [reflective of roughly 3 half-lives of EVUSHELD] prior to LMP, or (2) EVUSHELD was received on/after LMP during the exposure ascertainment period, which will vary based on the outcome of interest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of pregnancy outcomes potentially associated with exposure in early pregnancy and measured prior to 20 weeks gestation
Spontaneous abortion, Ectopic pregnancy
Measured: Index date to < 20 weeks of gestation
Risk of pregnancy outcomes potentially associated with exposure anytime during pregnancy and measured anytime during pregnancy
Maternal Death
Measured: Index date to end of pregnancy (Note: Maternal death outcome ascertainment period is up to 42 days after the end of pregnancy episode (EPE).)
Risk of pregnancy outcomes potentially associated with exposure anytime during pregnancy and measured after 20 weeks gestation
Preterm live birth, Stillbirth, Gestational hypertension, Pre-eclampsia, Gestational diabetes
Measured: Index date to end of pregnancy Note: For preterm birth, the outcome ascertainment period is 20 to 37 weeks of gestation
Risk of outcomes in neonates potentially associated with exposure anytime during pregnancy and measured 28 days after birth
Low birth weight, Small for gestational age, Respiratory distress syndrome in the newborn, Neonatal death
Measured: Diagnosed within 28 days of birth
Risk of outcomes in infants potentially associated with exposure anytime during pregnancy and measured within 12 months after birth
Major congenital malformations, Infant death, Failure to thrive
Measured: From birth to time of death or 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start27 Jun 2022 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Why it stopped: The MAH's proposal to remove the Study from the RMP is based on the change in circulating COVID-19 variants, which has led to a suspension of EUA and significant decrease in the use of EVUSHELD.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aetion, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847140
- Sponsor's protocol ID
- D8850R00006
- Acronym
- O-STEREO
- Status last verified
- Dec 2023
- First submitted
- 21 Feb 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Multi-country Cohort Study to Assess the Safety of EVUSHELD™ (Tixagevimab/Cilgavimab) During Pregnancy
- ClinicalTrials.gov ID
- NCT05847140
- Acronym / sponsor ID
- O-STEREO / D8850R00006
- Conditions
- Pregnancy, Pregnant Women, Pregnancy Outcome
- Keywords
- Pregnancy outcome, evusheld, pregnancy exposure, immunocompromised condition
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The MAH's proposal to remove the Study from the RMP is based on the change in circulating COVID-19 variants, which has led to a suspension of EUA and significant decrease in the use of EVUSHELD.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Aetion, Inc.
- Study start
- 27 Jun 2022 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 6 May 2023 (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.
Multi-country, non-interventional cohort study.The objective of the study is to characterise the risk of pregnancy and offspring (neonatal and infant) outcomes in pregnancies with and without exposure to EVUSHELD (used as a treatment or prophylaxis) among women of child-bearing indicated for such treatment in the real-world setting, using secondary data from US, France and Canada.
Detailed description
This is a multi-country, non-interventional cohort study in pregnancies exposed to EVUSHELD and pregnancies unexposed to EVUSHELD among women eligible for EVUSHELD. The study will be conducted within secondary data sources (administrative claims, electronic medical records (EMR) and/or registry data). For each country, the overall study period will span 12 months prior to the country-specific EVUSHELD availability until the end of the data cut or 31 March 2027, whichever is earlier.
The study will include pregnancies in individuals eligible for EVUSHELD therapy in each country in the selected datasets, including pregnant individuals aged 18 to 49 years with a high-risk condition documented in the 12 months prior to the start of the pregnancy, defined as the first day of the last menstrual period (LMP).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evusheld exposed pregnancies | – | –A pregnancy is considered exposed to EVUSHELD if 1 of 2 conditions are met: (1) EVUSHELD was received during the 36-week period [reflective of roughly 3 half-lives of EVUSHELD] prior to LMP, or (2) EVUSHELD was received on/after LMP during the exposure ascertainment period, which will vary based on the outcome of interest. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will include pregnancies in individuals eligible for EVUSHELD administration in each country, including pregnant females aged 18-49 years with a high-risk condition. Exposed and unexposed pregnancies will be identified from this population for outcome-specific analyses. EVUSHELD indication varies from one country to another and may evolve over the course of the study. In order to have a homogeneous study population and maximise its size, all countryspecific EVUSHELD eligibility criteria at the time of protocol development were considered to define the study population.
Key inclusion criteria (19 listed)
- Female sex at LMP
- Age 18-49 years at LMP
- Continuous coverage/clinical activity (dependent on data source type) within the confounder ascertainment period
- LMP date falls within the LMP eligibility period
- Occurrence of at least one of the following high-risk conditions during the confounder ascertainment period
Key exclusion criteria (2 listed)
- Multifoetal pregnancies are defined by the presence of any International Classification of Diseases (ICD-10) diagnosis code, any position indicating presence of more than one foetus (see code list) on the hospital record throughout the pregnancy episode
- Use of in vitro fertilisation or other assisted reproductive technology in the 36 weeks prior LMP as identified by ICD-10 diagnosis code "pregnancy resulting from assisted reproductive technology" or related procedure codes indicating in vitro fertilisation (IVF) or assisted reproductive technology (ART) (see code list) on the electronic health records (EHR) or hospital claims records 36 weeks prior to LMP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk of pregnancy outcomes potentially associated with exposure in early pregnancy and measured prior to 20 weeks gestation
Time frame: Index date to < 20 weeks of gestation
Spontaneous abortion, Ectopic pregnancy
Risk of pregnancy outcomes potentially associated with exposure anytime during pregnancy and measured anytime during pregnancy
Time frame: Index date to end of pregnancy (Note: Maternal death outcome ascertainment period is up to 42 days after the end of pregnancy episode (EPE).)
Maternal Death
Risk of pregnancy outcomes potentially associated with exposure anytime during pregnancy and measured after 20 weeks gestation
Time frame: Index date to end of pregnancy Note: For preterm birth, the outcome ascertainment period is 20 to 37 weeks of gestation
Preterm live birth, Stillbirth, Gestational hypertension, Pre-eclampsia, Gestational diabetes
Risk of outcomes in neonates potentially associated with exposure anytime during pregnancy and measured 28 days after birth
Time frame: Diagnosed within 28 days of birth
Low birth weight, Small for gestational age, Respiratory distress syndrome in the newborn, Neonatal death
Risk of outcomes in infants potentially associated with exposure anytime during pregnancy and measured within 12 months after birth
Time frame: From birth to time of death or 12 months of age
Major congenital malformations, Infant death, Failure to thrive
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Pregnant Women, run by AstraZeneca.
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 19 inclusion and 2 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: withdrawn, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Risk of pregnancy outcomes potentially associated with exposure in early pregnancy and measured prior to 20 weeks gestation (time frame: Index date to < 20 weeks of gestation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2023.