PREP (Pre-Exposure Prophylaxis) of COVID-19
- Registration Number
- NCT05461378
- Lead Sponsor
- Ghady Haidar
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 138
- Age ≥ 12 and at least 40 kg
- Eligible for EVUSHELD as per the EUA
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Select inpatients (SOT/HCT/CAR-T) 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 Individuals who have received EVUSHELD Evusheld Individuals who have received EVUSHELD within 9 months of enrollment. Outpatients Evusheld Outpatients who have not yet received EVUSHELD but who plan on receiving it in the future.
- Primary Outcome Measures
Name Time Method 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] 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.
- Secondary Outcome Measures
Name Time Method Proportion of participants with ≥1 COVID-19-related medically-attended visit 12-months Participants with ≥1 COVID-19-related medically-attended visit
Proportion of participants who die by the end of the study 12-months COVID-19 associated and all-cause mortality
Assessment of T-cell responses using an ELISPOT assay 12-months Obtained before and after vaccination
Determining SARS_CoV-2 variant type using whole genome sequencing 12-months Collected among subjects with breakthrough infection
Lifestyle Modification Questionnaire 12-months Proportion of participants who report changes in lifestyle
Concentration of AZD7442 in serum 12-months Collected at 1, 3, AND 9 months
Assessment of SARS-CoV-2 Spike IgG levels using Bioplex/Biorad assays, viral neutralization assay using competitive ACE2 EIA, and pseudovirus neutralization titers 12-months Collected at enrollment and 1, 3, 6, 9, and 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 12-months Collected during breakthrough infection
Trial Locations
- Locations (1)
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States