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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-04000 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20204 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| TGen | Other Identifier | Translational Genomics Research Institute (TGen) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| California Institute for Regenerative Medicine (CIRM) | OTHER |
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Plasma from patients who have recovered from coronavirus disease 2019 (COVID-19) is referred to as COVID-19 convalescent plasma (CCP), and may contain antibodies against SARS-CoV-2, the virus responsible for COVID-19. CCP infusion is being evaluated as a therapeutic or prophylactic approach in COVID-19 patients. The goal of this study is to help develop a bank of convalescent plasma in California, especially in medically underserved communities particularly affected by the disease. In parallel, CCP administered to COVID-19 patients will be collected and analyzed to determine whether the antibody profile correlates with clinical outcome. The purpose of this non-therapeutic study is to learn more about the CCP antibody profile and the effect it may have in treating COVID-19 infection.
PRIMARY OBJECTIVES:
I. Establish a testing service for screening prospective donors of coronavirus disease 2019 (COVID-19) convalescent plasma (CCP).
II. Characterize the titer and neutralizing properties of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in CCP.
III. Correlate the SARS-CoV-2 antibody characteristics in CCP with the outcome in severely ill COVID-19 patients treated with CCP.
EXPLORATORY OBJECTIVES:
I. Facilitate the recruitment of CCP donors in medically underserved areas.
II. Develop high-throughput methods for detection/characterization of SARS-CoV-2 neutralizing and non-neutralizing antibodies.
III. Develop a bank of convalescent plasma that would be available for future studies relating to the content of CCP.
IV. Study the impact of antibody levels, donor characteristics and patient characteristics on outcome in COVID-19 patients treated with CCP.
V. Procure blood samples from COVID-19 convalescent volunteers for future COVID-19-related studies.
OUTLINE:
PROSPECTIVE CCP DONORS: Participants undergo collection of blood and/or nasopharyngeal swabs at the time of screening. Participants' medical records are reviewed.
CONVALESCENT BLOOD DONORS WHO CHOOSE NOT TO DONATE CCP: Participants undergo collection of blood sample at the time of screening. Participants' medical records are reviewed.
CCP RECIPIENTS: Patients undergo collection collection of blood samples at baseline, between CCP unit infusions, 24 hours after last CCP infusion, and between 14-28 after last CCP infusion. Patients' medical records are reviewed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening (biospecimen collection, medical record review, CCP) | PROSPECTIVE CCP DONORS: Participants undergo collection of blood and/or nasopharyngeal swabs at the time of screening. Participants' medical records are reviewed. CONVALESCENT BLOOD DONORS WHO CHOOSE NOT TO DONATE CCP: Participants undergo collection of blood sample at the time of screening. Participants' medical records are reviewed. CCP RECIPIENTS: Patients undergo collection of blood samples at baseline, 12-24 hours after each CCP infusion, and 7 days after last CCP infusion. Patients' medical records are reviewed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood and/or nasopharyngeal swabs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Convalescent plasma (CCP) units infused in coronavirus disease-2019 (COVID-19) patients | Will be assayed for severe acute respiratory syndrome (SARS-CoV-2) immunoassay, coronavirus (CoV) PepSeq assay, and SARS-CoV-2 lenti-based neutralizing antibody titer. | Up to 12 months after enrollment |
| All-cause mortality | Will naturally be compared to reported data from the other studies. Analysis will focus on demonstrating that the antibody content of donor plasma increases the odds of surviving past day 28. Will also develop a nomogram for the probability of success (alive at day 28), accounting for patient, donor material and donor antibody characteristics measurable covariates. | At day 28 post-CCP infusion |
| Donor antibody levels | Will be examined to see how this relates to the duration of hospitalization. | Up to 28 days post-CCP infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Will be assessed on a 7-point ordinal scale, as recommended by the WHO patient outcome R&D Blueprint Group. | Up to 28 days post-CCP infusion |
| CCP recipient outcomes |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospitalization (days) | Patient can stay at the hospital for up to 28 days post-CCP infusion | Up to 28 days post-CCP infusion |
| Time to clinical improvement (days) | Will be assessed on a 7-point ordinal scale. |
For COVID-19 convalescent individuals:
Note: If volunteers can't provide evidence of COVID-19, but are otherwise eligible, then we will test them for SARS-CoV-2 antibodies to confirm eligibility.
For (COVID-19 convalescent plasma (CCP) recipients:
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Patients with diagnosis of laboratory-confirmed COVID-19 infection
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| Name | Affiliation | Role |
|---|---|---|
| John Zaia | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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Nasopharyngeal swab, blood samples
| Diagnostic Laboratory Biomarker Analysis | Other | Correlative studies |
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| Electronic Health Record Review | Other | Donors and recipients have their medical records reviewed. |
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| Questionnaire Administration | Other | Ancillary studies |
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Will be assessed on a 7-point ordinal scale. The scale is as follows:
| Up to 28 days post-CCP infusion |
| Up to 28 days post-CCP infusion |