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Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19

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ClinicalTrials.gov Identifier: NCT04445207
Expanded Access Status : Available
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Jonathan Gerber, University of Massachusetts, Worcester

Study Description
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Brief Summary:
The purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness.

Condition or disease Intervention/treatment
COVID Sars-CoV2 Corona Virus Infection Biological: Convalescent Plasma

Detailed Description:
As individuals are exposed to pathogens, the body's immune system works to create antibodies toward those pathogens. These antibodies can be found in the plasma portion of the blood. This plasma is referred to as "Convalescent plasma" and contains these infection fighting antibodies. Through a blood donation, this convalescent plasma is collected from a recovered person and transfused to a sick patient who is still fighting the same virus. This protocol will make convalescent COVID-19 plasma available to individuals who meet the eligibility criteria described.
Study Design
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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Biological: Convalescent Plasma
    One to two 200 mL units of Convalescent plasma per infusion, up to 6 total units within a 3-week period.
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • At least 12 years of age
  • Covid-19 Convalescent Plasma (CCP) treatment is in line with the patient's current goals of care (i.e. recipient cannot be DNI status)
  • Laboratory confirmed diagnosis of infection with SARS-CoV-2 that is severe or life threatening OR the individual is judged by the treating provider to be at a high risk of progression to severe or life-threatening disease.

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

    1. Dyspnea
    2. Respiratory frequency ≥ 30/min
    3. Blood oxygen saturation ≤ 93%
    4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
    5. Lung infiltrates > 50% within 24-48 hours

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

    1. Respiratory failure
    2. Septic shock
    3. Multiple organ dysfunction or failure

Exclusion Criteria:

  • History of prior life-threatening reactions to transfusion of blood products
  • Not receiving other therapies that would preclude plasma transfusion
Contacts and Locations
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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): NCT04445207


Contacts
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Contact: Jonathan Gerber, MD 508-856-3216 cancerresearch@umassmed.edu
Contact: Cara Gregoire 774-455-4458 Cara.Gregoire@umassmed.edu

Locations
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United States, Massachusetts
UMass Medical School Available
Worcester, Massachusetts, United States, 01655
Contact: Principal Investigator         
Sponsors and Collaborators
Jonathan Gerber
Investigators
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Principal Investigator: Jonathan Gerber, MD UMASS MEDICAL SCHOOL
More Information
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Responsible Party: Jonathan Gerber, Associate Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT04445207    
Other Study ID Numbers: H000020420
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Keywords provided by Jonathan Gerber, University of Massachusetts, Worcester:
COVID-19
Coronavirus
Sars-CoV2
Additional relevant MeSH terms:
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Coronavirus Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections