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Trial record 2 of 155 for:    covid-19 convalescent plasma

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

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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

Tracking Information
First Submitted Date May 6, 2020
First Posted Date June 9, 2020
Last Update Posted Date August 2, 2021
 
Descriptive Information
Brief Title Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients
Official Title Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients
Brief Summary This is an expanded access program providing COVID-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill COVID-19.
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 Type Expanded Access
Expanded Access Type Individual Patients, Intermediate-size Population
Condition
  • COVID-19
  • SARS-CoV 2
  • SARS-CoV Infection
Intervention 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Contacts
Contact: Marc Klapholz, MD, MBA 973-972-4595 klapholz@njms.rutgers.edu
Contact: Khyati Mehta, MPH 973-972-6794 mehtakp@njms.rutgers.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04420988
Other Study ID Numbers Pro2020000746, Pro2020000911
Responsible Party Marc Klapholz, M.D., Rutgers, The State University of New Jersey
Study Sponsor Rutgers, The State University of New Jersey
Collaborators University Hospital - Newark, NJ
Investigators
Principal Investigator: Marc Klapholz, MD, MBA Rutgers New Jersey Medical School; University Hospital
PRS Account Rutgers, The State University of New Jersey
Verification Date July 2021