Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445207
Expanded Access Status : Available
First Posted : June 24, 2020
Last Update Posted : March 8, 2022
Sponsor:
Information provided by (Responsible Party):
Jonathan Gerber, University of Massachusetts, Worcester

Study Description
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Jonathan Gerber, MD 508-856-3216 cancerresearch@umassmed.edu
Contact: Cara Gregoire 774-455-4458 Cara.Gregoire@umassmed.edu

Locations
Layout table for location information
United States, Massachusetts
UMass Medical School Available
Worcester, Massachusetts, United States, 01655
Contact: Principal Investigator         
Sponsors and Collaborators
Jonathan Gerber
Investigators
Layout table for investigator information
Principal Investigator: Jonathan Gerber, MD UMASS MEDICAL SCHOOL
More Information
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: March 8, 2022
Last Verified: March 2022
Keywords provided by Jonathan Gerber, University of Massachusetts, Worcester:
COVID-19
Coronavirus
Sars-CoV2
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases