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

Symptomatic COVID-19 Infection Laboratory-Confirmed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04497779
• Other study ID #: 20204
• Secondary ID: NCI-2020-0400020
• Status: Active, not recruiting
• Start date: July 13, 2020
• Est. completion date: June 10, 2024

Study information

• Verified date: February 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 95
• Est. completion date: June 10, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic COVID-19 Infection Laboratory-Confirmed
• Communicable Diseases
• COVID-19
• Infections
• Symptomatic COVID-19 Infection Laboratory-Confirmed

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood and/or nasopharyngeal swabs

Other:
• Diagnostic Laboratory Biomarker Analysis
Correlative studies
• Electronic Health Record Review
Donors and recipients have their medical records reviewed.
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (3)

Lead Sponsor	Collaborator
City of Hope Medical Center	California Institute for Regenerative Medicine (CIRM), National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Time to clinical improvement (days)	Will be assessed on a 7-point ordinal scale.	Up to 28 days post-CCP infusion
Primary	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
Primary	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
Primary	Donor antibody levels	Will be examined to see how this relates to the duration of hospitalization.	Up to 28 days post-CCP infusion
Secondary	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
Secondary	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