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Expanded Access to Convalescent Plasma for Treatment of 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: NCT04472572
Expanded Access Status : Available
First Posted : July 15, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

Brief Summary:
This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.

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

Detailed Description:
This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following enrollment on the protocol and provision of informed consent, patients will be transfused with approximately 200-500 mL of ABO compatible convalescent plasma obtained from individuals who have recovered from documented infection with SARS-CoV-2 and who have been found to have high anti-SARS-CoV2 titers. Safety information collected will include serious adverse events judged to be related to the administration of convalescent plasma. Other information to be collected retrospectively will include patient demographics, resource utilization (total length of stay, days in ICU, days intubated, and survival to discharge from the facility.

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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: Convalescent Plasma
    Fresh or frozen plasma will be infused one time to patients with COVID-19 infection

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.


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

Inclusion Criteria:

  1. Age at least 18 years
  2. Laboratory confirmed diagnosis of infection with SARS-CoV-2
  3. Admitted to the hospital for the treatment of COVID-19 complications
  4. 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
  5. Informed consent provided by the patient or healthcare proxy
  6. Severe COVID-19 is defined by one or more of the following:

    • dyspnea
    • respiratory frequency ≥ 30/min
    • blood oxygen saturation ≤ 93%
    • partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
    • lung infiltrates > 50% within 24 to 48 hours

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

  • respiratory failure/mechanical ventilation
  • septic shock
  • multiple organ dysfunction or failure

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): NCT04472572


Contacts
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Contact: Mariefel Vendivil 551-996-5828 Mariefel.Vendivil@HackensackMeridian.org
Contact: Marlo Kemp 551-996-4464 Marlo.Kemp@HackensackMeridian.org

Locations
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United States, New Jersey
Hackensack University Medical Center Available
Hackensack, New Jersey, United States, 07601
Contact: Mariefel Vendivil    551-996-5828    Mariefel.Vendivil@HackensackMeridian.org   
Contact: Marlo Kemp    551-996-4464    Marlo.Kemp@HackensackMeridian.org   
Principal Investigator: Michele L Donato, MD         
Sponsors and Collaborators
Hackensack Meridian Health
Investigators
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Principal Investigator: Michele Donato Hackensack Meridian Health
Publications:
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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT04472572    
Other Study ID Numbers: Pro2020-0663
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Keywords provided by Hackensack Meridian Health:
Coronavirus
Covid19
SARS-CoV-2