PREP (Pre-Exposure Prophylaxis) of COVID-19

NCT05461378 | Completed FDA Drug

• 1 other identifier: PrEP C-19
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immuno-Deficiency; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Concentration of AZD7442 in serum

  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

  12-months

• Assessment of T-cell responses using an ELISPOT assay

  12-months

• Determining SARS_CoV-2 variant type using whole genome sequencing

  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

  12-months

Study Arms (3)

Outpatients

Outpatients who have not yet received EVUSHELD but who plan on receiving it in the future.

Drug: 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

Individuals who have received EVUSHELD

Individuals who have received EVUSHELD within 9 months of enrollment.

Drug: Evusheld

Interventions

Evusheld DRUG

Participants who have received or plan to receive Evusheld.

Individuals who have received EVUSHELD; Outpatients; Select inpatients (SOT/HCT/CAR-T)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Immunocompromised Patients using the Monoclonal Antibody EVUSHELD (AZD7442)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ghady Haidar: lead
• AstraZeneca: collaborator

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum, and cellular components may be collected from whole blood samples. SARS-CoV-2 may be isolated from nasal and respiratory samples of persons with COVID-19. Investigators may also collect remnant swabs and blood from persons with COVID-19.

MeSH Terms

Conditions

COVID-19

Interventions

cilgavimab and tixagevimab drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ghady Haidar, MD

  University of Pittsburgh and UPMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 18, 2022
• Study Start: July 26, 2022
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)