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Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults (PassItOn)

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: NCT04362176
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : November 17, 2020
Sponsor:
Collaborators:
Dolly Parton
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University Medical Center

Brief Summary:
The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.

Condition or disease Intervention/treatment Phase
COVID-19 Coronavirus SARS-CoV-2 Biological: pathogen reduced SARS-CoV-2 convalescent plasma Biological: Placebo Phase 3

Detailed Description:
After being informed about the study and potential risks, participants confirmed to meet all eligibility criteria who have provided informed consent will be randomized 1:1 to convalescent plasma versus placebo. Transfusion of convalescent plasma or placebo will be administered by clinical or research personnel while the patient is hospitalized on Study Day 1. On Study Days 1-7, participants will be monitored for adverse reactions to the transfusion. Research personnel will also assess patients at Day 14 and Day 28; these assessments will be completed by phone if the participant has been discharged from the hospital.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible participants will be randomized 1:1 to convalescent plasma versus lactated Ringer's solution with multivitamins. Randomization will be completed in permuted blocks and stratified by site, gender, and age. Participants, treating clinicians and outcomes assessors will all be blinded to study group assignment. Study personnel will not be blinded to the study group assignment.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Passive Immunity Trial for Our Nation (PassItOn)
Actual Study Start Date : April 24, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pathogen reduced SARS-CoV-2 convalescent plasma
Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
Biological: pathogen reduced SARS-CoV-2 convalescent plasma
Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.

Placebo Comparator: Placebo
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Biological: Placebo
Lactated Ringer's solution with multivitamins




Primary Outcome Measures :
  1. COVID-19 7-point Ordinal Clinical Progression Outcomes Scale [ Time Frame: Study Day 15 ]
    1. Not hospitalized with resumption of normal activities.
    2. Not hospitalized, but unable to resume normal activities.
    3. Hospitalized, not on supplemental oxygen.
    4. Hospitalized, on supplemental oxygen.
    5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
    6. Hospitalized, on ECMO, invasive mechanical ventilation, or both.
    7. Death


Secondary Outcome Measures :
  1. All-location, all-cause 14-day mortality [ Time Frame: Baseline to Study Day 14 (assessed on Study Day 15) ]
    All-location, all-cause 14-day mortality

  2. All-location, all-cause 28-day mortality [ Time Frame: Baseline to Study Day 28 (assessed on Study Day 29) ]
    All-location, all-cause 28-day mortality

  3. Survival through 28 days [ Time Frame: Baseline to Day 28 (assessed on Study Day 29) ]
    Number of participants that survived to Day 28

  4. Time to hospital discharge through 28 days [ Time Frame: Admission to discharge (assessed on Study Day 29) ]
    Number days from admission to discharge thru Day 28

  5. COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 [ Time Frame: Baseline to Study Day 3 ]
    1. Not hospitalized with resumption of normal activities.
    2. Not hospitalized, but unable to resume normal activities.
    3. Hospitalized, not on supplemental oxygen.
    4. Hospitalized, on supplemental oxygen.
    5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
    6. Hospitalized, on ECMO, invasive mechanical ventilation, or both.
    7. Death

  6. COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 [ Time Frame: Study Day 8 ]
    1. Not hospitalized with resumption of normal activities.
    2. Not hospitalized, but unable to resume normal activities.
    3. Hospitalized, not on supplemental oxygen.
    4. Hospitalized, on supplemental oxygen.
    5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
    6. Hospitalized, on ECMO, invasive mechanical ventilation, or both.
    7. Death

  7. COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 [ Time Frame: Study Day 29 ]
    1. Not hospitalized with resumption of normal activities.
    2. Not hospitalized, but unable to resume normal activities.
    3. Hospitalized, not on supplemental oxygen.
    4. Hospitalized, on supplemental oxygen.
    5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
    6. Hospitalized, on ECMO, invasive mechanical ventilation, or both.
    7. Death

  8. Oxygen-free days through Day 28 [ Time Frame: Baseline to Day 28 ]
    Number of days without use of oxygen

  9. Ventilator-free days through Day 28 [ Time Frame: Baseline to Day 28 ]
    Number of days without use of a ventilator

  10. Vasopressor-free days through Day 28 [ Time Frame: Baseline to Day 28 ]
    Number of days without use of vasopressors

  11. ICU-free days through Day 28 [ Time Frame: Baseline to Day 28 ]
    Number of days outside of ICU

  12. Hospital-free days through Day 28 [ Time Frame: Baseline to Day 28 ]
    Number of days outside of the hospital


Other Outcome Measures:
  1. Acute kidney injury [ Time Frame: Baseline to Day 28 ]
    Number of participants with Acute kidney injury

  2. Renal replacement therapy [ Time Frame: Baseline to Day 28 ]
    Number of participants requiring renal replacement therapy

  3. Documented venous thromboembolic disease (DVT or PE) [ Time Frame: Baseline to Day 28 ]
    Number of participants with documented venous thromboembolic disease (DVT or PE)

  4. Documented cardiovascular event (myocardial infarction or ischemic stroke) [ Time Frame: Baseline to Day 28 ]
    Number of Participants with myocardial infarction or ischemic stroke

  5. Transfusion reaction [ Time Frame: Baseline to Day 28 ]
    Number of participants with transfusion reaction (fever/rash)

  6. Transfusion related acute lung injury (TRALI) [ Time Frame: Baseline to Day 28 ]
    Number of participants with transfusion related acute lung injury (TRALI)

  7. Transfusion associated circulatory overload (TACO) [ Time Frame: Baseline to Day 28 ]
    Number of participants with transfusion associated circulatory overload (TACO)

  8. Transfusion related infection [ Time Frame: Baseline to Day 28 ]
    Number of participants with transfusion related 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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than or equal to 18 years of age
  2. Currently hospitalized or in an emergency department with anticipated hospitalization
  3. Symptoms of acute respiratory infection, defined as one or more of the following:

    1. Cough
    2. Chills, or a fever (greater than 37.5° C or 99.5° F)
    3. Shortness of breath, operationalized as a patient having any of the following:

    i. Subjective shortness of breath reported by a patient or surrogate. ii. Tachypnea with respiratory rate of greater than 22 breaths per minute iii. Hypoxemia, defined as SpO2 less than 92% on room air, new receipt of supplemental oxygen to maintain SpO2 greater than or equal to 92%, or increased supplemental oxygen to maintain SpO2 greater than or equal to 92% for a patient on chronic oxygen therapy

  4. Laboratory-confirmed SARS-CoV-2 infection within the past 14 days

Exclusion Criteria:

  1. Prisoner
  2. Unable to randomize within 14 days after onset of acute respiratory infection symptoms
  3. Patient, legal representative, or physician not committed to full support (Exception: a patient who will receive all supportive care except for attempts at resuscitation from cardiac arrest will not be excluded.)
  4. Inability to be contacted on Day 29-36 for clinical outcome assessment
  5. Receipt of COVID-19 convalescent plasma or pooled immunoglobulin in the past 30 days
  6. Contraindications to transfusion or history of prior reactions to transfused blood products
  7. Plan for hospital discharge within 24 hours of enrollment
  8. Previous enrollment in this trial
  9. Enrollment in another clinical trial evaluating monoclonal antibodies, convalescent plasma, or another passive immunity therapy

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): NCT04362176


Contacts
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Contact: Amanda J Bistran-Hall (615) 875-8531 amanda.j.bistran-hall@vumc.org

Locations
Show Show 19 study locations
Sponsors and Collaborators
Vanderbilt University Medical Center
Dolly Parton
National Center for Advancing Translational Science (NCATS)
Investigators
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Principal Investigator: Todd Rice, MD Vanderbilt University Medical Center
Additional Information:
Publications:
Kidney Disease Improving Global Outcomes. KDIGO clinical practice guideline for acute kidney injury. Kidney Int. 2012;2: Suppl:1-138.
National Bioethics Advisory Commitee (NBAC). Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. U.S. Government Printing Office; 1998.
Dresser R. Research Involving Persons with Mental Disabilities: A Review of Policy Issues and Proposals. Rockville: U.S. Government Printing Office; 1998:5-28.

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Responsible Party: Todd Rice, Associate Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04362176    
Other Study ID Numbers: 200738
3UL1TR002243-04S3 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Todd Rice, Vanderbilt University Medical Center:
COVID-19 drug treatment
convalescent plasma
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases