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

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: Completed
• Conditions: COVID-19; Immuno-Deficiency
• Intervention / Treatment: Drug: Evusheld

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: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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]	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

Outcome Measure	Measure Description	Time Frame
Concentration of AZD7442 in serum	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	Collected at enrollment and 1, 3, 6, 9, and 12 months	12-months
Assessment of T-cell responses using an ELISPOT assay	Obtained before and after vaccination	12-months
Determining SARS_CoV-2 variant type using whole genome sequencing	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	Collected during breakthrough infection	12-months
Proportion of participants with ≥1 COVID-19-related medically-attended visit	Participants with ≥1 COVID-19-related medically-attended visit	12-months
Proportion of participants who die by the end of the study	COVID-19 associated and all-cause mortality	12-months
Lifestyle Modification Questionnaire	Proportion of participants who report changes in lifestyle	12-months

Collaborators and Investigators

• Sponsor: Ghady Haidar
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Ghady Haidar, MD, University of Pittsburgh and UPMC

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Actual): January 29, 2024
• Study Completion (Actual): January 29, 2024

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Immunologic Deficiency Syndromes; Anti-Infective Agents; Antiviral Agents; Cilgavimab and tixagevimab drug combination
• Other Study ID 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