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Trial record 1 of 1 for:    NCT04362176
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Passive Immunity Trial Of the Nation for COVID-19 (PassItOnII)

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ClinicalTrials.gov Identifier: NCT04362176
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : August 27, 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 Ordinal 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 0. 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 : 500 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: A Randomized, Controlled Clinical Trial to Test the Safety and Efficacy of Convalescent Donor Plasma to Treat COVID-19 in Hospitalized Adults
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 Ordinal Outcomes Scale:Day 15 [ Time Frame: Study Day 15 ]
    1. Death
    2. Hospitalized on invasive mechanical ventilation or ECMO
    3. Hospitalized on non-invasive ventilation or high flow nasal cannula
    4. Hospitalized on supplemental oxygen
    5. Hospitalized not on supplemental oxygen
    6. Not hospitalized with limitation in activity (continued symptoms)
    7. Not hospitalized without limitation in activity (no symptoms)


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

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

  3. COVID Ordinal Outcomes Scale Day 3 [ Time Frame: Baseline to Study Day 3 ]
    1. Death
    2. Hospitalized on invasive mechanical ventilation or ECMO
    3. Hospitalized on non-invasive ventilation or high flow nasal cannula
    4. Hospitalized on supplemental oxygen
    5. Hospitalized not on supplemental oxygen
    6. Not hospitalized with limitation in activity (continued symptoms)
    7. Not hospitalized without limitation in activity (no symptoms)

  4. COVID Ordinal Outcomes Scale Day 8 [ Time Frame: Study Day 8 ]
    1. Death
    2. Hospitalized on invasive mechanical ventilation or ECMO
    3. Hospitalized on non-invasive ventilation or high flow nasal cannula
    4. Hospitalized on supplemental oxygen
    5. Hospitalized not on supplemental oxygen
    6. Not hospitalized with limitation in activity (continued symptoms)
    7. Not hospitalized without limitation in activity (no symptoms)

  5. COVID Ordinal Outcomes Scale Day 29 [ Time Frame: Study Day 29 ]
    1. Death
    2. Hospitalized on invasive mechanical ventilation or ECMO
    3. Hospitalized on non-invasive ventilation or high flow nasal cannula
    4. Hospitalized on supplemental oxygen
    5. Hospitalized not on supplemental oxygen
    6. Not hospitalized with limitation in activity (continued symptoms)
    7. Not hospitalized without limitation in activity (no symptoms)

  6. Composite of death or receipt of ECMO through Day 28 [ Time Frame: Baseline to Day 28 ]
    Number of participants that died or received ECMO

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

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

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

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

  11. 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:

  • Age ≥18 years
  • Currently hospitalized or in an emergency department with anticipated hospitalization.
  • Symptoms of acute respiratory infection, defined as one or more of the following: cough, fever (> 37.5° C / 99.5° F), shortness of breath
  • Laboratory-confirmed SARS-CoV-2 infection within the past 10 days

Exclusion Criteria:

  • Prisoner
  • Unable to randomize within 14 days after onset of acute respiratory infection symptoms
  • Unable to randomize within 48 hours after hospital arrival
  • Inability to be contacted on Day 29-36 for clinical outcome assessment
  • Receipt of pooled immunoglobulin in the past 30 days
  • Contraindications to transfusion or history of prior reactions to transfusion blood products
  • Previous enrollment in this trial

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
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37203
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
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 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