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SARS-CoV-2VALOR C19 ILNCT05712096

eVusheld Assessment reaL wORld Effectiveness in Israel Clalit Health Services

An observational study of SARS-CoV-2 and COVID-19, run by AstraZeneca at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 EVUSHELD eligible patient population in the… Read more about this study

Who is it for?
Any age
Conditions the study is for
SARS-CoV-2, COVID-19
What is being tested?
EVUSHELD
How many people
4,000 participants
Where
1 siteIsrael
Study dates
9 Mar 2023to 30 May 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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All EVUSHELD PrEP-eligible patient population in the Clalit Health Services system

Who may be able to join

  • Aged 12 years and older as of the date of receipt of EVUSHELD
  • No record of infection or SARS-CoV- hospitalization within last 90 days prior to the index date
  • Individuals who are moderate/severe immune compromised due to a medical condition or receipt of immunosuppressive medications or treatments and may mount an adequate immune response to COVID-19 vaccine:
  • Hypogammaglobinemia patients regularly treated with immunoglobulins
  • Patients treated with B-cell depleting therapy, including for example such anti-CD20 as rituximab, obinatuzumab, ofatumumab, veltuzumab, Y-ibritumomab tiuxetan or ocrelizumab, even without malignant disease, up to six months from treatment.
  • Patients that are treated with B-cell depleting therapy (i.e. anti CD20, rituximab, Y-ibritumomab tiuxetan, veltuzumab, ofatumumab, obinatuzumab, ocrelizumab), without a malignant disease
Show all 15Show fewer
  • Bone marrow transplant (up to a year from the BMT) from outside donors, or with GVHD grades 3-4.
  • Bone marrow transplant (up to a 6 months after the BMT) from self
  • Patients after (CAR) T-cell therapy (chimeric antigen receptor T-cell therapy) up to 6 months from the treatment.
  • Lungs transplant recipients
  • Solid organ transplant recipients (who has any kind of transplant) or those who received ATG (anti thymocyte globulin) over the last 6 months
  • Patients with aggressive lymphoma.
  • Multiple Myeloma patients that have active disease, and on treatment at the time of study initiation.
  • Individuals who meet the criterion below will be excluded:
  • Per the current FDA EUA, individuals currently infected with SARS-CoV-2 are not eligible for EVUSHELD as PrEP. Therefore, in the main analysis, individuals who meet the following criteria will also be excluded.

Who cannot join

  • With evidence of COVID 19 (i.e., a positive diagnostic test, or COVID-19 diagnosis code) in the period of 90 days before (pseudo) index date OR
  • With evidence of SARS-CoV-2 infection on the (pseudo) index date or anytime within the 6-day period immediately following this date (i.e., index date to index date+6)

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Research Site

    Ramat Gan

Other trials in Israel

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 Immunocompromised Patients in Israel

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 EVUSHELD eligible patient population in the Clalit Health Services in Israel.

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 EVUSHELD eligible patient population in the Clalit Health Services in Israel.

Conditions
SARS-CoV-2, COVID-19
Being tested
EVUSHELD
Keywords
SARS-CoV-2, COVID-19, Immunocompromised Patients, Pre-exposure Prophylaxis Against COVID-19, Evusheld
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 (AZD 7442, Tixagévimab/Cilgavimab)

Study groups in NCT05712096
Study groupRoleWhat they receive
EVUSHELD ArmIndividuals given EVUSHELD for pre-exposure prophylaxis
Receives: Drug: EVUSHELD
Concurrent Control ArmIndividuals eligible for EVUSHELD pre-exposure prophylaxis but did not receive Evusheld

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospitalisation due to COVID-19

    Any record of admission to hospital that was reported to the Israeli MOH as hospitalization due to SARS-CoV-2

    Measured: up to 6 months

  2. All-cause mortality

    All-cause deaths reported in the patient's record

    Measured: up to 6 months

Secondary outcomes (6)

  1. Documented SARS-CoV-2 Infection, COVID-19 related mortality, Severe COVID-19

    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: 6 months and 12 months

  2. COVID-19 mortality

    Any record indicating death due to COVID-19 or record of death certificate mentioning SARS-CoV-2 as cause of death.

    Measured: 6 months and 12 months

  3. COVID-19-related healthcare resource utilization (HCRU)

    Any record of COVID-19 hospitalisation, ICU admission, mechanical ventilation and prescriptions of therapies for COVID-19

    Measured: 6 months

  4. COVID-19-related healthcare resource utilization

    Any record of hospital admission including hospital lenght of stay, ICU, mechanical ventilation, prescription/dispensations of antiviral drugs used for COVID-19 drugs

    Measured: 6 months

  5. SAEs/AESIs

    Any record of Serious Adverse Events (SAEs) or Adverse Events of Special Interests (AESIs) up to 6 months following initiation of Evusheld

    Measured: 6 months

  6. Adverse events (AEs)

    Any record of Adverse events up to 12 months following initiation of Evusheld

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2023
  2. Study start9 Mar 2023
  3. Primary completion30 May 2023
  4. Study completion30 May 2023

Resources

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
4,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05712096
Sponsor's protocol ID
D8850R00002
Acronym
VALOR C19 IL
Status last verified
Jan 2025
First submitted
26 Jan 2023
Last updated
21 Jan 2025
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.

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV-2 and COVID-19, run by AstraZeneca at 1 site in Israel.

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 15 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: finished, as of the sponsor's last update on 21 Jan 2025. 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 Israel. 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?

Hospitalisation 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?

On the ClinicalTrials.gov record for NCT05712096.

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 21 Jan 2025.

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