PREP (Pre-Exposure Prophylaxis) of COVID-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Immuno-Deficiency, COVID-19

Intervention / Treatment
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* Drug: Evusheld


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outpatients<br>Outpatients who have not yet received EVUSHELD but who plan on receiving it in the future. | Drug: Evusheld<br>* Participants who have received or plan to receive Evusheld.<br>|
| Select inpatients (SOT/HCT/CAR-T)<br>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<br>* Participants who have received or plan to receive Evusheld.<br>|
| Individuals who have received EVUSHELD<br>Individuals who have received EVUSHELD within 9 months of enrollment. | Drug: Evusheld<br>* Participants who have received or plan to receive Evusheld.<br>|

What is the study measuring?
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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 |