Clinical trial NCT05461378: PREP (Pre-Exposure Prophylaxis) of COVID-19
Official title: Prospective Observational Cohort Study of Pre-Exposure Prophylaxis of COVID-19 in Immunocompromised Patients Receiving the Monoclonal Antibody AZD7442 (EVUSHELD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immuno-Deficiency
COVID-19
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2022-07-18
Enrollment: 138
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Immunocompromised Patients using the Monoclonal Antibody EVUSHELD (AZD7442)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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]
timeFrame: 12-months
Secondary outcomes:
measure: Concentration of AZD7442 in serum
timeFrame: 12-months
measure: Assessment of SARS-CoV-2 Spike IgG levels using Bioplex/Biorad assays, viral neutralization assay using competitive ACE2 EIA, and pseudovirus neutralization titers
timeFrame: 12-months
measure: Assessment of T-cell responses using an ELISPOT assay
timeFrame: 12-months
measure: Determining SARS_CoV-2 variant type using whole genome sequencing
timeFrame: 12-months
measure: 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
timeFrame: 12-months
measure: Proportion of participants with ≥1 COVID-19-related medically-attended visit
timeFrame: 12-months
measure: Proportion of participants who die by the end of the study
timeFrame: 12-months
measure: Lifestyle Modification Questionnaire
timeFrame: 12-months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh and UPMC
name: Ghady Haidar, MD
role: PRINCIPAL_INVESTIGATOR
References: