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Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients

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: NCT04420988
Expanded Access Status : Available
First Posted : June 9, 2020
Last Update Posted : August 2, 2021
Sponsor:
Collaborator:
University Hospital - Newark, NJ
Information provided by (Responsible Party):
Marc Klapholz, M.D., Rutgers, The State University of New Jersey

Study Description
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Brief Summary:
This is an expanded access program providing COVID-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill COVID-19.

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

Detailed Description:
This expanded access program provides hospitalized patients who are severely or life-threateningly ill with COVID-19 access to investigational COVID-19 convalescent plasma (CCP). A clinical team comprised of Infectious Disease specialists, Pulmonary/Critical Care specialists and Hospitalists identify appropriate patients in accordance with FDA recommendations for patient eligibility and the daily availability of ABO-compatible CCP. CCP is obtained through New York Blood Center and American Red Cross in coordination with the University Hospital Blood Bank. Safety outcomes include monitoring for transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO) and any allergic reactions.Patients admitted to our institution prior to the availability of CCP will be separately reviewed.
Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients, Intermediate-size Population
Official Title: Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Biological: COVID-19 Convalescent Plasma
    COVID-19 Convalescent Plasma from recovered COVID-19 patients transfusion into severely or life-threateningly ill COVID-19 infected patients
Eligibility Criteria
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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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Laboratory confirmed COVID-19.
  2. Severe or life-threatening COVID-19. a) Severe disease is defined as one or more of the following: i) dyspnea, ii) respiratory frequency ≥ 30/min, iii) blood oxygen saturation ≤ 93%, iv) partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or v) lung infiltrates > 50% within 24 to 48 hours b) Life-threatening disease is defined as one or more of the following: i) respiratory failure, ii) septic shock, and/or iii) multiple organ dysfunction or failure

Exclusion Criteria:

  1. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)
  2. Severe multi-organ failure and hemodynamic instability requiring high doses of pressor agents
  3. Other documented uncontrolled infection
  4. Severe DIC needing factor replacement, FFP, cryoprecipitate
  5. Acute renal failure requiring dialysis
  6. Active intracranial bleeding
  7. Clinically significant myocardial ischemia
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): NCT04420988


Contacts
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Contact: Marc Klapholz, MD, MBA 973-972-4595 klapholz@njms.rutgers.edu
Contact: Khyati Mehta, MPH 973-972-6794 mehtakp@njms.rutgers.edu

Locations
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United States, New Jersey
Rutgers New Jersey Medical School Available
Newark, New Jersey, United States, 07103
University Hospital Available
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Rutgers, The State University of New Jersey
University Hospital - Newark, NJ
Investigators
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Principal Investigator: Marc Klapholz, MD, MBA Rutgers New Jersey Medical School; University Hospital
  Study Documents (Full-Text)

Documents provided by Marc Klapholz, M.D., Rutgers, The State University of New Jersey:
Informed Consent Form  [PDF] May 1, 2020

More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Marc Klapholz, M.D., Chair, Department of Medicine; Chief of Medicine Service, University Hospital, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT04420988    
Other Study ID Numbers: Pro2020000746, Pro2020000911
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Keywords provided by Marc Klapholz, M.D., Rutgers, The State University of New Jersey:
COVID-19 convalescent plasma
convalescent plasma transfusion
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases