Clincosm LogoSign in Get a demo

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

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Available
CT.gov ID
NCT04420988
Collaborator
University Hospital - Newark, NJ (Other)
2
Locations

Study Details

Study Description

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 Phase
  • 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

Study Type:
Expanded Access
Official Title:
Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Rutgers New Jersey Medical School Newark New Jersey United States 07103
    2 University Hospital Newark New Jersey United States 07103

    Sponsors and Collaborators

    • Rutgers, The State University of New Jersey
    • University Hospital - Newark, NJ

    Investigators

    • Principal Investigator: Marc Klapholz, MD, MBA, Rutgers New Jersey Medical School; University Hospital

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    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:
    Jun 9, 2020
    Last Update Posted:
    Aug 2, 2021
    Last Verified:
    Jul 1, 2021
    Keywords provided by Marc Klapholz, M.D., Chair, Department of Medicine; Chief of Medicine Service, University Hospital, Rutgers, The State University of New Jersey
    COVID-19 convalescent plasma
    convalescent plasma transfusion
    Additional relevant MeSH terms:
    COVID-19
    Severe Acute Respiratory Syndrome

    Study Results

    No Results Posted as of Aug 2, 2021