PREP (Pre-Exposure Prophylaxis) of COVID-19 (PrEP)

July 12, 2024 updated by: Ghady Haidar

Prospective Observational Cohort Study of Pre-Exposure Prophylaxis of COVID-19 in Immunocompromised Patients Receiving the Monoclonal Antibody AZD7442 (EVUSHELD)

This is a study of immunocompromised individuals who have received or plan to receive a drug called EVUSHELD. This study is looking at any serious adverse events that might happen after receiving EVUSHELD, the levels of EVUSHELD in participant's blood, blood antibody levels, neutralizing antibodies against SARS-CoV-2 (the virus that causes COVID-19), and other blood responses related to the immune system and COVID-19. Investigators are collecting blood and may also collect other samples such as nose swabs, oral swabs, or saliva.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective study of 500 immunocompromised participants at UPMC health system. EVUSHELD will be given according to the EUA in the United States as a part of standard of care by the patient's health care provider. Patients who receive intramuscular EVUSHELD as standard of care will be enrolled and followed for 12-months. The target sample size is 500 immunocompromised individuals; serum concentrations of AZD7442 will be obtained in all patients at the 6 (or at enrollment if the time point has passed) and 12 month timepoints.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Immunocompromised Patients using the Monoclonal Antibody EVUSHELD (AZD7442)

Description

Inclusion Criteria:

  • Age ≥ 12 and at least 40 kg
  • Eligible for EVUSHELD as per the EUA

Exclusion Criteria:

  • Active and confirmed COVID-19
  • Known or suspected pregnancy, concurrent lactation
  • Any other significant disease, disorder, or finding, in the opinion of the investigator, that may significantly increase the risk to the participant because of participation in the study, affect the ability of the subject to participate in the study, or impair interpretation of the study data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Outpatients
Outpatients who have not yet received EVUSHELD but who plan on receiving it in the future.
Drug: Evusheld
Participants who have received or plan to receive Evusheld.
Select inpatients (SOT/HCT/CAR-T)
Newly transplanted adult solid organ transplant and HCT recipients, as well as CAR-T-cell therapy recipients, during their hospitalization to undergo SOT/HCT/CAR-T-cell therapy
Drug: Evusheld
Participants who have received or plan to receive Evusheld.
Individuals who have received EVUSHELD
Individuals who have received EVUSHELD within 9 months of enrollment.
Drug: Evusheld
Participants who have received or plan to receive Evusheld.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Concentration of AZD7442 in serum over time [ENROLLMENT, 6 MONTHS, 12 MONTHS] Concentration of AZD7442 in serum over time [ENROLLMENT, 6 MONTHS, 12 MONTHS] Concentration of AZD7442 in serum over time [ENROLLMENT, 6 MONTHS, 12 MONTHS]
Time Frame: 12-months
The primary objective of PrEP C-19 is to measure AZD7442 serum concentration levels by blood draws at 6 months (or at enrollment if the time point has passed) and 12 months after IM administration of EVUSHELD.
12-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concentration of AZD7442 in serum
Time Frame: 12-months
Collected at 1, 3, AND 9 months
12-months
Assessment of SARS-CoV-2 Spike IgG levels using Bioplex/Biorad assays, viral neutralization assay using competitive ACE2 EIA, and pseudovirus neutralization titers
Time Frame: 12-months
Collected at enrollment and 1, 3, 6, 9, and 12 months
12-months
Assessment of T-cell responses using an ELISPOT assay
Time Frame: 12-months
Obtained before and after vaccination
12-months
Determining SARS_CoV-2 variant type using whole genome sequencing
Time Frame: 12-months
Collected among subjects with breakthrough infection
12-months
Determining Concentration of AZD7442 in serum, SARS-CoV-2 Spike IgG levels using Bioplex/Biorad assays, viral neutralization assay using competitive ACE2 EIA, and pseudovirus neutralization titers
Time Frame: 12-months
Collected during breakthrough infection
12-months
Proportion of participants with ≥1 COVID-19-related medically-attended visit
Time Frame: 12-months
Participants with ≥1 COVID-19-related medically-attended visit
12-months
Proportion of participants who die by the end of the study
Time Frame: 12-months
COVID-19 associated and all-cause mortality
12-months
Lifestyle Modification Questionnaire
Time Frame: 12-months
Proportion of participants who report changes in lifestyle
12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ghady Haidar

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ghady Haidar, MD, University of Pittsburgh and UPMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PrEP C-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Share study reports to AstraZeneca, de-identified data only will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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