SARS-CoV-2, COVID-19VALOR-VANCT05663957
eVusheld Assessment reaL wORld Effectiveness in the VA Health System
An observational study of SARS-CoV-2, COVID-19, run by AstraZeneca at 1 site in United States.
Trial summary
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- SARS-CoV-2, COVID-19
- What is being tested?
- Evusheld
- How many people
- 5,814 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2023to 1 Sep 2023
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All EUA-eligible immunocompromised patient population in the Department of Veterans Affairs Health System.
Who may be able to join
- Receipt of EVUSHELD under the FDA EUA for EVUSHELD
- Eligibility to access EVUSHELD use under the EUA.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study to Assess the Real-World Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations Receiving Care in VA Health System in the United States
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the Department of Veterans Affairs (VA) Health System.
Read the detailed description
This a Phase IV observational, secondary data study to assess the effectiveness of Evusheld in preventing COVID-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system.
The study is designed as an AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the VA Health System.
- Conditions
- SARS-CoV-2, COVID-19
- Being tested
- Evusheld
- Keywords
- EVUSHELD, tixagevimab and cilgavimab, Pre-exposure prophylaxis, COVID-19, SARS-CoV-2, Effectiveness
- 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
EVUSHELD users
| Study group | Role | What they receive |
|---|---|---|
| EVUSHELD arm | Individuals given EVUSHELD for prophylaxis Receives: Drug: Evusheld | |
| Concurrent Control arm | Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization due to COVID-19
Hospital record of patient admission
Measured: up to 6 months
All-cause mortality
All-cause deaths
Measured: Up to 6 months
Secondary outcomes (5)
Documented SARS-COV-2 infection
Any positive SARS-CoV-2 diagnostic test (eg, PCR, nucleic acid amplification, antigen) OR medical encounter resulting in a diagnosis code for COVID-19b OR medical encounter resulting in a code for isolation due to COVID-19
Measured: up to 6 and 12 months
Medically attended COVID-19
COVID-19 or SARS-CoV-2 infection leading to consultation of a healthcare professional
Measured: up to 6 and 12 months
COVID-19 hospitalisation
Hospitalisation due to COVID-19
Measured: up to 12 months
COVID-19 Intensive Care Unit (ICU) admisssion
ICU admission due to COVID-19
Measured: up to 6 and 12 months
COVID-19-related mortality
Death due to COVID-19
Measured: up to 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start4 Jan 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2, 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
- Retrospective
- Enrolment
- 5,814 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VA Informatics and Computing Infrastructure (VINCI)
- Responsible party
- Sponsor
- Investigators
- Scott L DuVall, PhD, Principal investigator, VA Informatics and Computing Infrastructure (VINCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663957
- Sponsor's protocol ID
- D8850R00014
- Other IDs
- D8850R00014
- Acronym
- VALOR-VA
- Status last verified
- Aug 2024
- First submitted
- 22 Sep 2022
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Assess the Real-World Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations Receiving Care in VA Health System in the United States
- ClinicalTrials.gov ID
- NCT05663957
- Acronym / sponsor ID
- VALOR-VA / D8850R00014
- Conditions
- SARS-CoV-2, COVID-19
- Keywords
- EVUSHELD, tixagevimab and cilgavimab, Pre-exposure prophylaxis, COVID-19, SARS-CoV-2, Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,814 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- VA Informatics and Computing Infrastructure (VINCI)
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 23 Dec 2022 (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.
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the Department of Veterans Affairs (VA) Health System.
Detailed description
This a Phase IV observational, secondary data study to assess the effectiveness of Evusheld in preventing COVID-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system.
The study is designed as an AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the VA Health System.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVUSHELD arm | – | Drug: EvusheldIndividuals given EVUSHELD for prophylaxis |
| Concurrent Control arm | – | –Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All EUA-eligible immunocompromised patient population in the Department of Veterans Affairs Health System.
Key inclusion criteria (2 listed)
- Receipt of EVUSHELD under the FDA EUA for EVUSHELD
- Eligibility to access EVUSHELD use under the EUA.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| EvusheldEVUSHELD users | Drug | EVUSHELD arm |
Primary outcome
Hospitalization due to COVID-19
Time frame: up to 6 months
Hospital record of patient admission
All-cause mortality
Time frame: Up to 6 months
All-cause deaths
5 secondary outcomes
Documented SARS-COV-2 infection
Time frame: up to 6 and 12 months
Medically attended COVID-19
Time frame: up to 6 and 12 months
COVID-19 hospitalisation
Time frame: up to 12 months
COVID-19 Intensive Care Unit (ICU) admisssion
Time frame: up to 6 and 12 months
COVID-19-related mortality
Time frame: up to 6 and 12 months
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 3 Sep 2024.
- Redacted CSR Synopsis D8850R00014Link provided by the sponsor.
- 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.
Scott L DuVall, PhD principal investigator
VA Informatics and Computing Infrastructure (VINCI)
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 SARS-CoV-2, COVID-19, run by AstraZeneca at 1 site in United States.
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 3 Sep 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 United States. 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?
Hospitalization due to COVID-19 (time frame: up to 6 months). The study lists 2 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 3 Sep 2024.