Convalescent Plasma for the Treatment of Patients With COVID-19

August 26, 2020 updated by: University of Colorado, Denver

This expanded access program will provide access to COVID-19 convalescent plasma 150 or more individuals with moderate to severe or life-threatening manifestations of COVID-19, or documented to be at high risk of developing such manifestations at participating hospitals in Colorado.COVID-19 convalescent plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19.

Convalescent plasma collected from individuals who have recovered from COVID-19 contains antibodies to SARS-CoV-2. Preliminary evidence and data collected during other respiratory virus outbreaks (including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic) suggest that the antibodies in convalescent plasma may be effective in fighting the infection.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

COVID-19 convalescent plasma will be obtained from FDA registered blood banks and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).

The primary objective of this expanded access program is to provide COVID-19 convalescent plasma to patients with moderate to severe or life-threatening manifestations of COVID-19, or documented to be at high risk of developing such manifestations.

The secondary objective will be the evaluation of safety, as assessed by incidents of adverse events judged by the treating physician to be potentially related to the administration of COVID-19 convalescent plasma.

Exploratory objectives will include assessments for antibody responses for patients that receive convalescent plasma. An exploratory analysis may be conducted correlating the level of neutralizing antibody titers with clinical outcomes observed. Due to the need to monitoring COVID19 antibody responses following infusion, blood testing at day 1 post-treatment and at discharge will be obtained as part of enrollment.

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Colorado Springs, Colorado, United States, 80920
        • UCHealth Memorial Hospital North
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center
      • Fort Collins, Colorado, United States, 80524
        • UCHealth Poudre Valley Hospital
      • Highlands Ranch, Colorado, United States, 80129
        • UCHealth Highlands Ranch Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Laboratory confirmed diagnosis of infection with SARS-CoV-2
  • Age at least 18 years
  • Laboratory confirmed diagnosis of infection with SARS-CoV-2
  • Admitted to participating facility for the treatment of COVID-19 complications
  • Moderate-to-Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
  • Informed consent provided by the patient or healthcare proxy

  • Moderate COVID-19 is defined by one or more of the following:

    • Hospitalized with COVID-19
    • Respiratory rate >25/min
    • Oxygen saturation <96%
    • With or without radiographic evidence of pulmonary involvement

  • Severe COVID-19 is defined by one or more of the following:

    • dyspnea
    • respiratory frequency ≥ 30/min
    • blood oxygen saturation ≤ 93%
    • Radiographic evidence of pulmonary disease

  • Life-threatening COVID-19 is defined as one or more of the following:

    • respiratory failure requiring mechanical ventilation or non-rebreather oxygenation in the Intensive Care Unit.
    • Prone oxygenation.
    • multiple organ dysfunction or failure

Exclusion Criteria:

  • Does not meet inclusion criteria
  • History of transfusion reactions or contraindication to receiving convalescent plasma
  • Risk of transfusion exceeds potential benefit based on clinician or blood bank determination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: John D Beckham, MD, University of Colorado Denver, Anschutz Medical Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Actual)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-0990

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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