Immuno-DeficiencyPrEPNCT05461378
PREP (Pre-Exposure Prophylaxis) of COVID-19
An observational study of Immuno-Deficiency and COVID-19, run by Ghady Haidar at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Immuno-Deficiency, COVID-19
- What is being tested?
- Evusheld
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2022to 29 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Immunocompromised Patients using the Monoclonal Antibody EVUSHELD (AZD7442)
Who may be able to join
- Age ≥ 12 and at least 40 kg
- Eligible for EVUSHELD as per the EUA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Immuno-Deficiency, COVID-19
- Being tested
- Evusheld
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvusheldDrug
Participants who have received or plan to receive Evusheld.
| Study group | Role | What they receive |
|---|---|---|
| Outpatients | Outpatients who have not yet received EVUSHELD but who plan on receiving it in the future. Receives: Drug: Evusheld | |
| 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 Receives: Drug: Evusheld | |
| Individuals who have received EVUSHELD | Individuals who have received EVUSHELD within 9 months of enrollment. Receives: Drug: Evusheld |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-months
Secondary outcomes (8)
Concentration of AZD7442 in serum
Collected at 1, 3, AND 9 months
Measured: 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
Measured: 12-months
Assessment of T-cell responses using an ELISPOT assay
Obtained before and after vaccination
Measured: 12-months
Determining SARS_CoV-2 variant type using whole genome sequencing
Collected among subjects with breakthrough infection
Measured: 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
Measured: 12-months
Proportion of participants with ≥1 COVID-19-related medically-attended visit
Participants with ≥1 COVID-19-related medically-attended visit
Measured: 12-months
Proportion of participants who die by the end of the study
COVID-19 associated and all-cause mortality
Measured: 12-months
Lifestyle Modification Questionnaire
Proportion of participants who report changes in lifestyle
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start26 Jul 2022
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immuno-DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ghady Haidar
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Ghady Haidar, University of Pittsburgh
- Investigators
- Ghady Haidar, MD, Principal investigator, University of Pittsburgh and UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461378
- Sponsor's protocol ID
- PrEP C-19
- Acronym
- PrEP
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2022
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Share study reports to AstraZeneca, de-identified data only will be shared
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Cohort Study of Pre-Exposure Prophylaxis of COVID-19 in Immunocompromised Patients Receiving the Monoclonal Antibody AZD7442 (EVUSHELD)
- ClinicalTrials.gov ID
- NCT05461378
- Acronym / sponsor ID
- PrEP / PrEP C-19
- Conditions
- Immuno-Deficiency, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Ghady HaidarUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Outpatients | – | Drug: EvusheldOutpatients who have not yet received EVUSHELD but who plan on receiving it in the future. |
| Select inpatients (SOT/HCT/CAR-T) | – | Drug: EvusheldNewly 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 | – | Drug: EvusheldIndividuals who have received EVUSHELD within 9 months of enrollment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Immunocompromised Patients using the Monoclonal Antibody EVUSHELD (AZD7442)
Key inclusion criteria (2 listed)
- Age ≥ 12 and at least 40 kg
- Eligible for EVUSHELD as per the EUA
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvusheldParticipants who have received or plan to receive Evusheld. | Drug | Individuals who have received EVUSHELD, Outpatients, Select inpatients (SOT/HCT/CAR-T) |
Primary outcome
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]
Time frame: 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.
8 secondary outcomes
Concentration of AZD7442 in serum
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
Time frame: 12-months
Assessment of T-cell responses using an ELISPOT assay
Time frame: 12-months
Determining SARS_CoV-2 variant type using whole genome sequencing
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
Time frame: 12-months
Proportion of participants with ≥1 COVID-19-related medically-attended visit
Time frame: 12-months
Proportion of participants who die by the end of the study
Time frame: 12-months
Lifestyle Modification Questionnaire
Time frame: 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No. Share study reports to AstraZeneca, de-identified data only will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghady Haidar, MD principal investigator
University of Pittsburgh and UPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immuno-Deficiency and COVID-19, run by Ghady Haidar at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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] (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.