COVID-19; SARS-CoV-2; 2019 Novel Coronavirus DiseaseVALOR DoDNCT05569408
eVusheld Assessment reaL wORld Effectiveness in DoD Health System
An observational study of COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease, 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 treated in… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease
- What is being tested?
- EVUSHELD
- How many people
- 4,724 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2023to 22 Dec 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 patient population in the Department of Defence health system.
Who may be able to join
- Receipt of Evusheld under the FDA EUA for Evusheld
- Eligibility for 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 in the United States Department of Defense Healthcare System
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 treated in DoD 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 DoD health system.
- 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
Also called AZD7442
Tixagevimab (AZD8895) and cilgavimab (AZD1061)
| Study group | Role | What they receive |
|---|---|---|
| EVUSHELD Arm | Individuals given EVUSHELD for prophylaxis Receives: Drug: EVUSHELD | |
| Concurrent Control Arms | Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD Receives: Drug: EVUSHELD |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Hospitalisation
To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalizations up to 6 months following its initial administration
Measured: up to 6 months
All-cause mortality
To compare all-cause mortality up to 6 months following the initial dose of EVUSHELD, among subjects who did and did not receive EVUSHELD as PrEP
Measured: up to 6 months
Secondary outcomes (5)
Documented SARS-CoV-2 infection
To assess the effectiveness of EVUSHELD as PrEP against SARS-CoV-2 infection
Measured: Up to 6 and 12 months
Medically attended COVID-19
To assess the effectiveness of EVUSHELD as PrEP against medically attended COVID-19
Measured: Up to 6 and 12 months
COVID-19 hospitalisation
To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation at 12 month
Measured: Up 12 months
COVID-19 Intensive Care Unit (ICU) admisssion
To assess the effectiveness of EVUSHELD as PrEP against ICU admission
Measured: Up 6 and 12 months
COVID-19 related mortality
To assess the effectiveness of EVUSHELD as PrEP against COVID-19-related mortality
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 posted6 Oct 2022
- Study start10 Aug 2023
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19; SARS-CoV-2; 2019 Novel Coronavirus DiseaseStudies 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
- 4,724 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569408
- Sponsor's protocol ID
- D8850R00016
- Acronym
- VALOR DoD
- Status last verified
- Sep 2024
- First submitted
- 4 Oct 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 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 in the United States Department of Defense Healthcare System
- ClinicalTrials.gov ID
- NCT05569408
- Acronym / sponsor ID
- VALOR DoD / D8850R00016
- Keywords
- Evusheld, tixagevimab and cilgavimab, Pre-exposure prophylaxis, COVID-19, SARS-CoV-2, Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,724 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 6 Oct 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 treated in DoD 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 DoD 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 Arms | – | Drug: EVUSHELDIndividuals 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 patient population in the Department of Defence health system.
Key inclusion criteria (2 listed)
- Receipt of Evusheld under the FDA EUA for Evusheld
- Eligibility for 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 |
|---|---|---|
| EVUSHELDAlso: AZD7442Tixagevimab (AZD8895) and cilgavimab (AZD1061) | Drug | Concurrent Control Arms, EVUSHELD Arm |
Primary outcome
COVID-19 Hospitalisation
Time frame: up to 6 months
To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalizations up to 6 months following its initial administration
All-cause mortality
Time frame: up to 6 months
To compare all-cause mortality up to 6 months following the initial dose of EVUSHELD, among subjects who did and did not receive EVUSHELD as PrEP
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 12 months
COVID-19 Intensive Care Unit (ICU) admisssion
Time frame: Up 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 19 Sep 2024.
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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; SARS-CoV-2; 2019 Novel Coronavirus Disease, 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 19 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?
COVID-19 Hospitalisation (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 19 Sep 2024.