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Convalescent Plasma for the 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: NCT04389710
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
This protocol provides access to investigational convalescent plasma for patients in acute care facilities 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 provision of informed consent, patients will be transfused with 1-2 units of ABO compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2 (as detailed in separate protocol). Safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. Other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated), and survival to discharge from acute care facility.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Convalescent Plasma Phase 2

Detailed Description:
This is an open-label expanded access program to make appropriately matched convalescent plasma available for the treatment of patients in acute care facilities 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. COVID-19 convalescent plasma will be obtained from the Jefferson Blood Bank and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Provide access to COVID-19 convalescent plasma for patients infected with SARS-CoV-2 currently hospitalized in acute care facilities
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Convalescent Plasma for the Treatment of Patients With COVID-19
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : April 14, 2021
Estimated Study Completion Date : April 14, 2021

Arm Intervention/treatment
Experimental: Intervention Group
Participants included in the experimental group will receive 200-600 milliliters of convalescent plasma, administered at a rate of 100-250 mL/hr
Drug: Convalescent Plasma
One to two units (200-600 mL) of ABO compatible COVID-19 convalescent plasma




Primary Outcome Measures :
  1. Number of patients who receive COVID-19 convalescent plasma transfusions in acute care facilities infected with SARS-CoV-2 [ Time Frame: 1 year ]
    Percentage of patients who are consented and ultimately receive convalescent plasma transfusion.


Secondary Outcome Measures :
  1. Number and type of adverse events associated with COVID-19 convalescent plasma in patients with COVID-19 [ Time Frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days ]
    Adverse Events including transfusion reaction (fever, rash), transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), and transfusion infection

  2. Length of hospital stay [ Time Frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days ]
    Days of hospitalization

  3. Length of Intensive Care Unit stay [ Time Frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days ]
    Days of Intensive Care Unit management

  4. Length of intubation [ Time Frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days ]
    Days of intubation requirement

  5. Survival to discharge [ Time Frame: 0, 1, 2, 3, 7, 14, 28, 60, and 90 days ]
    Proportion of patients who are successfully discharged from acute care facility

  6. Changes in complete blood count in patients after receiving convalescent plasma [ Time Frame: 0 and 7 days ]
    Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).

  7. Abnormal changes in Basic Metabolic Panel (BMP) measures in patients after receiving convalescent plasma [ Time Frame: 0 and 7 days ]
    BMP tests include measures of glucose, calcium, sodium, potassium, bicarbonate, chloride, blood urea nitrogen, and creatinine. Changes of interest include those that are flagged as abnormal. Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).

  8. Changes in C-Reactive Protein (CRP) in patients after receiving convalescent plasma [ Time Frame: 0 and 7 days ]
    Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).

  9. Changes in d-dimer in patients after receiving convalescent plasma [ Time Frame: 0 and 7 days ]
    Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).

  10. Changes in fibrinogen in patients after receiving convalescent plasma [ Time Frame: 0 and 7 days ]
    Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).

  11. Changes in prothrombin time (PT) in patients after receiving convalescent plasma [ Time Frame: 0 and 7 days ]
    Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).

  12. Changes in partial thromboplastin time (PTT) in patients after receiving convalescent plasma [ Time Frame: 0 and 7 days ]
    Laboratory values will be evaluated at day 0 and 7 (or the day of hospital discharge, if sooner).



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:

  • Age 18 years and older
  • Laboratory confirmed diagnosis of SARS-CoV-2
  • Admitted to an acute care facility for the treatment of COVID-19 complications
  • Informed consent provided by patient or legally authorized representative
  • 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

Severe Disease defined as any of the following

  • Dyspnea
  • Respiratory rate > 30/minute
  • Oxygen saturation <94%
  • Partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300
  • Lung infiltrates >50% within 24 to 48 hours

Life-threatening disease defined as any of the following

  • Respiratory failure
  • Septic shock
  • Multiple organ dysfunction or failure • Informed consent provided by patient or healthcare proxy

Exclusion Criteria:

  • Receipt of pooled immunoglobulin in past 30 days
  • Contraindication to transfusion or history of prior reactions to transfusion blood products

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): NCT04389710


Contacts
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Contact: Michael Baram, MD 215-955-5161 Michael.Baram@jefferson.edu
Contact: Anna Marie Chang, MD 215-605-5897 AnnaMarie.Chang@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Michael Baram, MD       Michael.Baram@Jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04389710    
Other Study ID Numbers: 20D.379
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No