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Active, Not Recruiting

NCT Number: NCT04497779

Analysis 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood and/or nasopharyngeal swabs

diagnostic laboratory biomarker analysis

Other

Correlative studies

Electronic Health Record Review

Other

Donors and recipients have their medical records reviewed.

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Convalescent plasma (CCP) units infused in coronavirus disease-2019 (COVID-19) patients

    Time frame: Up to 12 months after enrollment

    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.

  2. All-cause mortality

    Time frame: At day 28 post-CCP infusion

    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.

  3. Donor antibody levels

    Time frame: Up to 28 days post-CCP infusion

    Will be examined to see how this relates to the duration of hospitalization.

Secondary outcomes

  1. Incidence of adverse events

    Time frame: Up to 28 days post-CCP infusion

    Will be assessed on a 7-point ordinal scale, as recommended by the WHO patient outcome R&D Blueprint Group.

  2. CCP recipient outcomes

    Time frame: Up to 28 days post-CCP infusion

    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

Other outcomes

  1. Duration of hospitalization (days)

    Time frame: Up to 28 days post-CCP infusion

    Patient can stay at the hospital for up to 28 days post-CCP infusion

  2. Time to clinical improvement (days)

    Time frame: Up to 28 days post-CCP infusion

    Will be assessed on a 7-point ordinal scale.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • California Institute for Regenerative Medicine (CIRM)
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2020
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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