Evaluation of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asymptomatic COVID-19 Infection Laboratory-Confirmed
- Sponsor
- City of Hope Medical Center
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- All-cause mortality
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
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.
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 Outcomes
- Incidence of adverse events(Up to 28 days post-CCP infusion)
- CCP recipient outcomes(Up to 28 days post-CCP infusion)