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

City of Hope

Status: Active, not recruiting

Conditions: Symptomatic COVID-19 Infection Laboratory-Confirmed; Asymptomatic COVID-19 Infection Laboratory-Confirmed

Treatments: Other: Electronic Health Record Review; Procedure: Biospecimen Collection; Other: Questionnaire Administration; Other: Diagnostic Laboratory Biomarker Analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04497779

20204 (Other Identifier)

TGen (Other Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

NCI-2020-04000 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

95 participants in 1 patient group

Screening (biospecimen collection, medical record review, CCP)

Description:

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.

Treatment:

Other: Diagnostic Laboratory Biomarker Analysis

Other: Questionnaire Administration

Procedure: Biospecimen Collection

Other: Electronic Health Record Review