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Convalescent Plasma for the Treatment of Patients With COVID-19

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ClinicalTrials.gov Identifier: NCT04372368
Expanded Access Status : No longer available
First Posted : May 4, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.


Condition or disease Intervention/treatment
COVID-19 SARS-CoV 2 Biological: COVID-19 Convalescent Plasma

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.

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: Convalescent Plasma for the Treatment of Patients With COVID-19

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: COVID-19 Convalescent Plasma
    1-2 units of COVID-19 convalescent plasma will be administered over 1 to 2 hours (rate of 100 to 200 mL/hr)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372368


Locations
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United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
University of Colorado Hospital
Aurora, Colorado, United States, 80045
UCHealth Memorial Hospital North
Colorado Springs, Colorado, United States, 80920
Denver Health Medical Center
Denver, Colorado, United States, 80204
UCHealth Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States, 80129
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: John D Beckham, MD University of Colorado Denver, Anschutz Medical Campus
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04372368    
Other Study ID Numbers: 20-0990
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Keywords provided by University of Colorado, Denver:
COVID-19
SARS-CoV-2
Coronavirus