An observational study in Immuno-Deficiency and COVID-19, sponsored by Ghady Haidar. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-07-15.
Sponsored by Ghady Haidar · Observational
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.
7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 138 is below the median of 260 across 3,188 observational studies indexed under COVID-19.
Browse COVID-19 studies →Ghady Haidar is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Immunocompromised Patients using the Monoclonal Antibody EVUSHELD (AZD7442)
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Exclusion Criteria:
Outpatients who have not yet received EVUSHELD but who plan on receiving it in the future.
Drug: Evusheld
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
Drug: Evusheld
Individuals who have received EVUSHELD within 9 months of enrollment.
Drug: Evusheld
Participants who have received or plan to receive Evusheld.
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.
Time frame: 12-months
Concentration of AZD7442 in serum
Collected at 1, 3, AND 9 months
Time frame: 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
Collected at enrollment and 1, 3, 6, 9, and 12 months
Time frame: 12-months
Assessment of T-cell responses using an ELISPOT assay
Obtained before and after vaccination
Time frame: 12-months
Determining SARS_CoV-2 variant type using whole genome sequencing
Collected among subjects with breakthrough infection
Time frame: 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
Time frame: 12-months
Proportion of participants with ≥1 COVID-19-related medically-attended visit
Participants with ≥1 COVID-19-related medically-attended visit
Time frame: 12-months
Proportion of participants who die by the end of the study
COVID-19 associated and all-cause mortality
Time frame: 12-months
Lifestyle Modification Questionnaire
Proportion of participants who report changes in lifestyle
Time frame: 12-months
Plan to share: No — Share study reports to AstraZeneca, de-identified data only will be shared
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Jan 2024, 18 months.
Of 1,625 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 18 months is above that.
Counting every sponsor, half of 1,750 studies reached it within 13 months; a quarter within 5 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Ghady Haidar