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

Ghady Haidar

Status: Completed

Conditions: COVID-19; Immuno-Deficiency

Treatments: Drug: Evusheld

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05461378

PrEP C-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

138 participants in 3 patient groups

Outpatients

Description:

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

Treatment:

Drug: Evusheld

Select inpatients (SOT/HCT/CAR-T)

Description:

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

Treatment:

Drug: Evusheld

Individuals who have received EVUSHELD

Description:

Individuals who have received EVUSHELD within 9 months of enrollment.

Treatment:

Drug: Evusheld