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Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497779
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : September 21, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Asymptomatic COVID-19 Infection Laboratory-Confirmed Symptomatic COVID-19 Infection Laboratory-Confirmed Procedure: Biospecimen Collection Other: Diagnostic Laboratory Biomarker Analysis Other: Electronic Health Record Review Other: Questionnaire Administration

Detailed Description:

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Actual Study Start Date : July 13, 2020
Estimated Primary Completion Date : August 21, 2021
Estimated Study Completion Date : August 21, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.

 Procedure: Biospecimen Collection
Undergo collection of blood and/or nasopharyngeal swabs

Other: Diagnostic Laboratory Biomarker Analysis
Correlative studies

Other: Electronic Health Record Review
Donors and recipients have their medical records reviewed.

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Convalescent plasma (CCP) units infused in coronavirus disease-2019 (COVID-19) patients [ Time Frame: Up to 12 months after enrollment ]
    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.

  2. All-cause mortality [ Time Frame: At day 28 post-CCP infusion ]
    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.

  3. Donor antibody levels [ Time Frame: Up to 28 days post-CCP infusion ]
    Will be examined to see how this relates to the duration of hospitalization.


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 28 days post-CCP infusion ]
    Will be assessed on a 7-point ordinal scale, as recommended by the WHO patient outcome R&D Blueprint Group.

  2. CCP recipient outcomes [ Time Frame: Up to 28 days post-CCP infusion ]

    Will be assessed on a 7-point ordinal scale. The scale is as follows:

    1. Death;
    2. Hospitalized, on invasive mechanical ventilation or ECMO;
    3. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    4. Hospitalized, requiring low flow supplemental oxygen;
    5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
    6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per protocol RDV administration);
    7. Not hospitalized


Other Outcome Measures:
  1. Duration of hospitalization (days) [ Time Frame: Up to 28 days post-CCP infusion ]
    Patient can stay at the hospital for up to 28 days post-CCP infusion

  2. Time to clinical improvement (days) [ Time Frame: Up to 28 days post-CCP infusion ]
    Will be assessed on a 7-point ordinal scale.


Biospecimen Retention:   Samples With DNA
Nasopharyngeal swab, blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosis of laboratory-confirmed COVID-19 infection
Criteria

For COVID-19 convalescent individuals:

  • Age: ≥ 18 years
  • Evidence of COVID-19 documented by a laboratory test either by: a diagnostic test (e.g., a NP swab) at the time of illness OR a positive serological test for SARS-CoV-2 antibodies after recovery, if prior diagnostic testing was not performed at the time COVID-19 was suspected.

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.

  • Be willing to complete a pre-screening questionnaire
  • Be willing to donate blood samples
  • Permit medical record review
  • For prospective CCP donors only: weigh more than 110 pounds and be in general good health

For (COVID-19 convalescent plasma (CCP) recipients:

  • Be enrolled in a clinical trial involving the infusion of CCP for the treatment of COVID-19.
  • Be willing to provide blood samples
  • Permit medical record review
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497779


Locations
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United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: John Zaia    626-218-1817    jzaia@coh.org   
Principal Investigator: John Zaia         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
California Institute for Regenerative Medicine (CIRM)
Investigators
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Principal Investigator: John Zaia City of Hope Medical Center
More Information
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Additional Information:

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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT04497779    
Other Study ID Numbers: 20204
NCI-2020-04000 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
20204 ( Other Identifier: City of Hope Medical Center )
P30CA033572 ( U.S. NIH Grant/Contract )
TGen ( Other Identifier: Translational Genomics Research Institute (TGen) )
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Laboratory Infection
Occupational Diseases