Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatients | Outpatients who have not yet received EVUSHELD but who plan on receiving it in the future. |
| |
| 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 |
| |
| Individuals who have received EVUSHELD | Individuals who have received EVUSHELD within 9 months of enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evusheld | Drug | Participants who have received or plan to receive Evusheld. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of AZD7442 in serum | Collected at 1, 3, AND 9 months | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Immunocompromised Patients using the Monoclonal Antibody EVUSHELD (AZD7442)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ghady Haidar, MD | University of Pittsburgh and UPMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
Share study reports to AstraZeneca, de-identified data only will be shared
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000714168 | cilgavimab and tixagevimab drug combination |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Collected at enrollment and 1, 3, 6, 9, and 12 months
| 12-months |
| Assessment of T-cell responses using an ELISPOT assay | Obtained before and after vaccination | 12-months |
| Determining SARS_CoV-2 variant type using whole genome sequencing | Collected among subjects with breakthrough infection | 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 | Collected during breakthrough infection | 12-months |
| Proportion of participants with ≥1 COVID-19-related medically-attended visit | Participants with ≥1 COVID-19-related medically-attended visit | 12-months |
| Proportion of participants who die by the end of the study | COVID-19 associated and all-cause mortality | 12-months |
| Lifestyle Modification Questionnaire | Proportion of participants who report changes in lifestyle | 12-months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |