This study investigates convalescent plasma (CCP) collected from the blood of patients who have recovered from COVID-19 before use in treating patients with current COVID-19 infection as well as the antibodies targeting SARS-CoV-2 in the blood of patients receiving CCP to correlate the effect of these antibodies to the outcome of the CCP recipients. “Convalescent plasma” means that the plasma is coming from someone who has recovered from a COVID-19 infection. SARS-CoV-2 is the virus causing the COVID-19 disease. An antibody is a protein made by plasma cells (a type of white blood cell) in response to an antigen (a substance that causes the body to make a specific immune response). Each antibody can bind to only one specific antigen. The purpose of this binding is to help destroy the antigen. There may be antibodies present in CCP, that target SARS-CoV-2. The purpose of this study is to learn more about COVID-19 convalescent plasma and the effect it may have in treating COVID-19 infection.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04497779.
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 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 of blood samples at baseline, 12-24 hours after each CCP infusion, 7-14 days after last CCP infusion, and 28 days after last CCP infusion. Patients' medical records are reviewed.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationCity of Hope Comprehensive Cancer Center
Principal InvestigatorJohn Zaia
