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

NCT04497779 | Active Not Recruiting DMC

• 4 other identifiers: 20204NCI-2020-04000P30CA033572TGen
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Incidence of adverse events

  Up to 28 days post-CCP infusion

• CCP recipient outcomes

  Up to 28 days post-CCP infusion

Other Outcomes (2)

• Duration of hospitalization (days)

  Up to 28 days post-CCP infusion

• Time to clinical improvement (days)

  Up to 28 days post-CCP infusion

Study Arms (1)

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.

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

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood and/or nasopharyngeal swabs

Screening (biospecimen collection, medical record review, CCP)

Diagnostic Laboratory Biomarker Analysis OTHER

Correlative studies

Screening (biospecimen collection, medical record review, CCP)

Electronic Health Record Review OTHER

Donors and recipients have their medical records reviewed.

Screening (biospecimen collection, medical record review, CCP)

Questionnaire Administration OTHER

Ancillary studies

Screening (biospecimen collection, medical record review, CCP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of laboratory-confirmed COVID-19 infection

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• City of Hope Medical Center: lead
• California Institute for Regenerative Medicine (CIRM): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab, blood samples

Study Officials

• John Zaia

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: August 4, 2020
• Study Start: July 13, 2020
• Primary Completion (Estimated): October 13, 2026
• Study Completion (Estimated): October 13, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (1)