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Convalescent Plasma for the Treatment of Patients With COVID-19

Primary Purpose

COVID-19, SARS-CoV 2

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
COVID-19 Convalescent Plasma
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for COVID-19 focused on measuring COVID-19, SARS-CoV-2, Coronavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • Children's Hospital Colorado
  • University of Colorado Hospital
  • UCHealth Memorial Hospital North
  • Denver Health Medical Center
  • UCHealth Poudre Valley Hospital
  • UCHealth Highlands Ranch Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 29, 2020
Last Updated
August 26, 2020
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04372368
Brief Title
Convalescent Plasma for the Treatment of Patients With COVID-19
Official Title
Convalescent Plasma for the Treatment of Patients With COVID-19
Study Type
Expanded Access

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV 2
Keywords
COVID-19, SARS-CoV-2, Coronavirus

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
COVID-19 Convalescent Plasma
Intervention Description
1-2 units of COVID-19 convalescent plasma will be administered over 1 to 2 hours (rate of 100 to 200 mL/hr)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Beckham, MD
Organizational Affiliation
University of Colorado Denver, Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UCHealth Memorial Hospital North
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
UCHealth Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
UCHealth Highlands Ranch Hospital
City
Highlands Ranch
State/Province
Colorado
ZIP/Postal Code
80129
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Convalescent Plasma for the Treatment of Patients With COVID-19

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