NCT04497779

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 95 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Asymptomatic COVID-19 Infection Laboratory-Confirmed
• Symptomatic COVID-19 Infection Laboratory-Confirmed

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-13
• Primary completion: 2026-10-13
• Completion: 2026-10-13
• First posted: 2020-08-04
• Last updated: 2025-12-05

Locations

1 site across 1 country: United States