COVID-19Evusheld DBRNCT06156982
An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan
An observational study of COVID-19, run by AstraZeneca at 1 site in Japan.
Trial summary
This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- Evusheld
- How many people
- 397 participants
- Where
- 1 siteJapan
- Study dates
- 6 Dec 2023to 9 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who have a record of administration of EVUSHELD in the database and meet the inclusion criteria and do not meet the exclusion criteria will be included in the study.
Who may be able to join
- Immunocompromised patients who were administrated EVUSHELD as PrEP and have administration date of EVUSHELD
- patients aged ≥ 12 years at the index date
Who cannot join
- Patients who have no medical visit records at any time in the 12 months preceding the index date
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.
All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.
Read the detailed description
This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.
All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.
- Conditions
- COVID-19
- Being tested
- Evusheld
- Keywords
- COVID-19, SARS-CoV-2, PrEP
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvusheldDrug
Administration of Evusheld 600 mg
| Study group | Role | What they receive |
|---|---|---|
| Evusheld administered group | Not described Receives: Drug: Evusheld |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics and clinical characteristics of patients received Evusheld as PrEP
Proportion of patients by age, gender, and clinical characteristics of interest (i.e. comorbidity, concurrent medication) between 360 days from the date of first administration of Evusheld (index date) to the index date will be described.
Measured: Up to 360 days before the date of first administration of Evusheld
Secondary outcomes (4)
Medically attended COVID-19
Event rate and time to event for medically attended COVID-19 up to 180 days after the date of first administration of Evusheld will be described
Measured: Up to 180 days after the date of first administration of Evusheld
COVID-19 hospitalization
Event rate and time to event for COVID-19 hospitalization up to 180 days after the date of first administration of Evusheld will be described
Measured: Up to 180 days after the date of first administration of Evusheld
In-hospital mortality due to COVID-19
Event rate and time to event for in-hospital mortality due to COVID-19 up to 180 days after the date of first administration of Evusheld will be described
Measured: Up to 180 days after the date of first administration of Evusheld
All cause mortality
Event rate and time to event for all cause mortality up to 180 days after the date of first administration of Evusheld will be described
Measured: Up to 180 days after the date of first administration of Evusheld
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start6 Dec 2023
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Other
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156982
- Sponsor's protocol ID
- D8850R00032
- Acronym
- Evusheld DBR
- Status last verified
- Jun 2024
- First submitted
- 6 Nov 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan
- ClinicalTrials.gov ID
- NCT06156982
- Acronym / sponsor ID
- Evusheld DBR / D8850R00032
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, PrEP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 5 Dec 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.
This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.
All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.
Detailed description
This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.
All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evusheld administered group | – | Drug: Evusheld |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who have a record of administration of EVUSHELD in the database and meet the inclusion criteria and do not meet the exclusion criteria will be included in the study.
Key inclusion criteria (2 listed)
- Immunocompromised patients who were administrated EVUSHELD as PrEP and have administration date of EVUSHELD
- patients aged ≥ 12 years at the index date
Key exclusion criteria (1 listed)
- Patients who have no medical visit records at any time in the 12 months preceding the index date
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 |
|---|---|---|
| EvusheldAdministration of Evusheld 600 mg | Drug | Evusheld administered group |
Primary outcome
Demographics and clinical characteristics of patients received Evusheld as PrEP
Time frame: Up to 360 days before the date of first administration of Evusheld
Proportion of patients by age, gender, and clinical characteristics of interest (i.e. comorbidity, concurrent medication) between 360 days from the date of first administration of Evusheld (index date) to the index date will be described.
4 secondary outcomes
Medically attended COVID-19
Time frame: Up to 180 days after the date of first administration of Evusheld
COVID-19 hospitalization
Time frame: Up to 180 days after the date of first administration of Evusheld
In-hospital mortality due to COVID-19
Time frame: Up to 180 days after the date of first administration of Evusheld
All cause mortality
Time frame: Up to 180 days after the date of first administration of Evusheld
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 26 Jun 2024.
- redacted CSR SynopsisLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by AstraZeneca at 1 site in Japan.
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 2 inclusion and 1 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 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. 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 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?
Demographics and clinical characteristics of patients received Evusheld as PrEP (time frame: Up to 360 days before the date of first administration of Evusheld). 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 26 Jun 2024.