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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asymptomatic COVID-19 Infection Laboratory-Confirmed; Symptomatic COVID-19 Infection Laboratory-Confirmed
• Intervention / Treatment: Other: Questionnaire Administration; Other: Diagnostic Laboratory Biomarker Analysis; Procedure: Biospecimen Collection; Other: Electronic Health Record Review

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 Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of laboratory-confirmed COVID-19 infection

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

Other: Questionnaire Administration; Ancillary studies; Other: Diagnostic Laboratory Biomarker Analysis; Correlative studies; Procedure: Biospecimen Collection; Undergo collection of blood and/or nasopharyngeal swabs; Other: Electronic Health Record Review; Donors and recipients have their medical records reviewed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Convalescent plasma (CCP) units infused in coronavirus disease-2019 (COVID-19) patients	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.	Up to 12 months after enrollment
All-cause mortality	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.	At day 28 post-CCP infusion
Donor antibody levels	Will be examined to see how this relates to the duration of hospitalization.	Up to 28 days post-CCP infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Will be assessed on a 7-point ordinal scale, as recommended by the WHO patient outcome R&D Blueprint Group.	Up to 28 days post-CCP infusion
CCP recipient outcomes	Will be assessed on a 7-point ordinal scale. The scale is as follows: Death;; Hospitalized, on invasive mechanical ventilation or ECMO;; Hospitalized, on non-invasive ventilation or high flow oxygen devices;; Hospitalized, requiring low flow supplemental oxygen;; Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);; Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per protocol RDV administration);; Not hospitalized	Up to 28 days post-CCP infusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospitalization (days)	Patient can stay at the hospital for up to 28 days post-CCP infusion	Up to 28 days post-CCP infusion
Time to clinical improvement (days)	Will be assessed on a 7-point ordinal scale.	Up to 28 days post-CCP infusion

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI); California Institute for Regenerative Medicine (CIRM)
• Investigators: Principal Investigator: John Zaia, City of Hope Medical Center

Publications and helpful links

Helpful Links

• Website to register participants for the study

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Estimated): June 10, 2024
• Study Completion (Estimated): June 10, 2024

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Occupational Diseases; COVID-19; Infections; Communicable Diseases; Laboratory Infection
• Other Study ID Numbers: 20204 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2020-04000 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); TGen (Other Identifier: Translational Genomics Research Institute (TGen))

Drug and device information, study documents

• 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