Covid19 ImmunologyCPRCNCT04474288
The COVID-19 PUI Reality Check (CPRC) Study
An observational study of Covid19 Immunology, run by Bassett Healthcare at 1 site in United States.
Trial summary
This study compares SARS-CoV-2 immune responses in high pretest probability swab negative hospitalized PUI patients vs. low pretest probability swab negative hospitalized APS (Asymptomatic Persons being Screened) patients to try to understand the appropriateness and safety of clinical decisions made in these patient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19 Immunology
- What is being tested?
- SARS-CoV-2 antibody testing
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2020to 28 Feb 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients who have had pharyngeal testing negative for the presence of COVID-19
Who may be able to join
- Hospitalized patient (PUI or APS) and tested for SARS-CoV-2 by NP PCR swab
- At least one negative SARS-CoV-2 NP PCR swab within 2 wks of hospitalization
- Adult >/= 18 yrs old
- Patient or LAR provides informed consent
- Patient or LAR agree to follow-up procedures in informed consent form
Who cannot join
- Prior reaction to blood drawing considered significant safety issue by study investigator
- Other factor considered significant safety issue by study investigator
- At least one positive SARS-CoV-2 NP PCR swab within 2 wks of hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARS-CoV-2 Specific Immune Responses in Hospitalized Persons Under Investigation (PUIs) With Negative Nasopharyngeal PCR Swabs - The COVID-19 PUI Reality Check (CPRC) Study
This study compares SARS-CoV-2 immune responses in high pretest probability swab negative hospitalized PUI patients vs. low pretest probability swab negative hospitalized APS (Asymptomatic Persons being Screened) patients to try to understand the appropriateness and safety of clinical decisions made in these patient populations based on swab results.
Read the detailed description
This is essentially a two phase blood drawing and immune assays study. Phase 1 will be a single convalescent timing immune retrospective study; phase 2 will include paired samples to increase immune response accuracy in a prospective study. In phase 1, hospitalized PUI and APS patients with negative nasopharyngeal PCR swabs selected by Epic query of Bassett records, will be contacted by telephone (or in person if hospitalized), offered enrollment in the study, and provided informed consent if they're interested. For consented/enrolled patients, routine baseline demographic and clinical data will be obtained by interview (in person or telephone) and/or EMR (Epic) review. These data will be needed to describe baseline characteristics and to assess for predictors of serologic conversion and other immune responses in the two study populations. Up to two to three visits will be required for brief interviews, record review, and blood draws. Phase 1 patients will have visits/blood draws on days 14 and 28 after hospitalization or at 28 days after hospitalization only (-3 days, +60 days) if patients are beyond day 14 at the time of study initiation; phase 2 patients will have visits/blood draws aiming for days 0, 14 (+/- 3 days), and 28 (+/- 3 days) after hospital admission.
Blood will be drawn for SARS-CoV-2 specific immune assays (below). For phase 1 patients, baseline immune assays will not be available as blood is not available for them; thus, for many phase 1 patients, only one of the day 14 and 28 immune assays will be practical. In Phase 2, these procedures will be the same except baseline blood draws will be possible at hospitalization as well. Thus, blood drawing will be at target days 0, 14, and 28 for phase 2 patients. Short interviews at days 14 and 28 will be conducted to assess for new COVID-19 compatible illnesses that may confound immune response results.
Up to 27.5 ml of blood will be required at each timepoint (PAXgene tube 2.5 ml, heparinized tube 10 ml, EDTA tube 10 ml, SST tube 5 ml). Total blood drawing will be up to 55 ml in phase 1 patients and up to 82.5 ml in phase 2 patients. Serologic and additional immune assays will be conducted on blood drawn at these time points to assess for SARS-CoV-2 specific immune responses (see below).
- Conditions
- Covid19 Immunology
- Being tested
- SARS-CoV-2 antibody testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 antibody testingDiagnostic test
venipuncture for SARS-CoV-2 IgG
| Study group | Role | What they receive |
|---|---|---|
| Person Under Investigation (PUI) | PUI's are subjects who were admitted to the hospital with symptoms suspicious for COVID-19. Receives: Diagnostic Test: SARS-CoV-2 antibody testing | |
| Asymptomatic Person under Screening (APS) | APS's are those patients who do NOT meet the criteria to be a suspect COVID- 19 patient but are being tested because they are being admitted, are required for testing by state mandate, or are having a procedure, etc. Receives: Diagnostic Test: SARS-CoV-2 antibody testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 IgG
Qualitative seroconversion response rates (RR) in NP SARS-CoV-2 PCR swab negative PUI vs. swab negative APS patients will be compared as the primary outcome measurement.
Measured: 120 days
Secondary outcomes (2)
host immune response
mRNA gene expression by RNAseq from whole blood collected into PAXGene RNA tubes
Measured: 120 Days
pathogen protein expression
identification of a signature of differentially expressed host genes or antigen/epitope specific antibody or cellular responses.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start16 Jul 2020
- Primary completion1 Jul 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19 ImmunologyStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bassett Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- Bioreference, Inc
- Responsible party
- Principal investigator, Daniel Freilich, MD, Bassett Healthcare
- Investigators
- Daniel Freilich, MD, Principal investigator, Bassett Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474288
- Sponsor's protocol ID
- 1613182
- Acronym
- CPRC
- Status last verified
- Mar 2022
- First submitted
- 15 Jul 2020
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Specific Immune Responses in Hospitalized Persons Under Investigation (PUIs) With Negative Nasopharyngeal PCR Swabs - The COVID-19 PUI Reality Check (CPRC) Study
- ClinicalTrials.gov ID
- NCT04474288
- Acronym / sponsor ID
- CPRC / 1613182
- Conditions
- Covid19 Immunology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Bassett HealthcareUniversity, hospital or other
- Collaborators
- Bioreference, Inc
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 16 Jul 2020 (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 study compares SARS-CoV-2 immune responses in high pretest probability swab negative hospitalized PUI patients vs. low pretest probability swab negative hospitalized APS (Asymptomatic Persons being Screened) patients to try to understand the appropriateness and safety of clinical decisions made in these patient populations based on swab results.
Detailed description
This is essentially a two phase blood drawing and immune assays study. Phase 1 will be a single convalescent timing immune retrospective study; phase 2 will include paired samples to increase immune response accuracy in a prospective study. In phase 1, hospitalized PUI and APS patients with negative nasopharyngeal PCR swabs selected by Epic query of Bassett records, will be contacted by telephone (or in person if hospitalized), offered enrollment in the study, and provided informed consent if they're interested. For consented/enrolled patients, routine baseline demographic and clinical data will be obtained by interview (in person or telephone) and/or EMR (Epic) review. These data will be needed to describe baseline characteristics and to assess for predictors of serologic conversion and other immune responses in the two study populations. Up to two to three visits will be required for brief interviews, record review, and blood draws. Phase 1 patients will have visits/blood draws on days 14 and 28 after hospitalization or at 28 days after hospitalization only (-3 days, +60 days) if patients are beyond day 14 at the time of study initiation; phase 2 patients will have visits/blood draws aiming for days 0, 14 (+/- 3 days), and 28 (+/- 3 days) after hospital admission.
Blood will be drawn for SARS-CoV-2 specific immune assays (below). For phase 1 patients, baseline immune assays will not be available as blood is not available for them; thus, for many phase 1 patients, only one of the day 14 and 28 immune assays will be practical. In Phase 2, these procedures will be the same except baseline blood draws will be possible at hospitalization as well. Thus, blood drawing will be at target days 0, 14, and 28 for phase 2 patients. Short interviews at days 14 and 28 will be conducted to assess for new COVID-19 compatible illnesses that may confound immune response results.
Up to 27.5 ml of blood will be required at each timepoint (PAXgene tube 2.5 ml, heparinized tube 10 ml, EDTA tube 10 ml, SST tube 5 ml). Total blood drawing will be up to 55 ml in phase 1 patients and up to 82.5 ml in phase 2 patients. Serologic and additional immune assays will be conducted on blood drawn at these time points to assess for SARS-CoV-2 specific immune responses (see below).
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Person Under Investigation (PUI) | – | Diagnostic Test: SARS-CoV-2 antibody testingPUI's are subjects who were admitted to the hospital with symptoms suspicious for COVID-19. |
| Asymptomatic Person under Screening (APS) | – | Diagnostic Test: SARS-CoV-2 antibody testingAPS's are those patients who do NOT meet the criteria to be a suspect COVID- 19 patient but are being tested because they are being admitted, are required for testing by state mandate, or are having a procedure, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients who have had pharyngeal testing negative for the presence of COVID-19
Key inclusion criteria (5 listed)
- Hospitalized patient (PUI or APS) and tested for SARS-CoV-2 by NP PCR swab
- At least one negative SARS-CoV-2 NP PCR swab within 2 wks of hospitalization
- Adult >/= 18 yrs old
- Patient or LAR provides informed consent
- Patient or LAR agree to follow-up procedures in informed consent form
Key exclusion criteria (3 listed)
- Prior reaction to blood drawing considered significant safety issue by study investigator
- Other factor considered significant safety issue by study investigator
- At least one positive SARS-CoV-2 NP PCR swab within 2 wks of hospitalization
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 |
|---|---|---|
| SARS-CoV-2 antibody testingvenipuncture for SARS-CoV-2 IgG | Diagnostic test | Asymptomatic Person under Screening (APS), Person Under Investigation (PUI) |
Primary outcome
SARS-CoV-2 IgG
Time frame: 120 days
Qualitative seroconversion response rates (RR) in NP SARS-CoV-2 PCR swab negative PUI vs. swab negative APS patients will be compared as the primary outcome measurement.
2 secondary outcomes
host immune response
Time frame: 120 Days
pathogen protein expression
Time frame: 120 days
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 11 Mar 2022.
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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.
Daniel Freilich, MD principal investigator
Bassett Medical Center
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 Covid19 Immunology, run by Bassett Healthcare 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 5 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 11 Mar 2022. 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?
SARS-CoV-2 IgG (time frame: 120 days). 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 11 Mar 2022.