NCT05461378

PREP (Pre-Exposure Prophylaxis) of COVID-19

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 138 (actual)
• Sponsor: Ghady Haidar · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Immuno-Deficiency
• COVID-19

Interventions

Type	Name	Description
DRUG	Evusheld	Participants who have received or plan to receive Evusheld.

Timeline

• Start date: 2022-07-26
• Primary completion: 2024-01-29
• Completion: 2024-01-29
• First posted: 2022-07-18
• Last updated: 2024-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study