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)

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.

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.

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