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

Primary Purpose

COVID-19, Coronavirus, SARS-CoV-2

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
pathogen reduced SARS-CoV-2 convalescent plasma
Placebo
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19 drug treatment, convalescent plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age greater than or equal to 18 years
  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 any SARS-CoV-2 passive immunity therapy, such as convalescent plasma, monoclonal antibodies, 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. Previous laboratory-confirmed SARS-CoV-2 infection before the current illness
  10. Enrollment in another clinical trial evaluating monoclonal antibodies, convalescent plasma, or another passive immunity therapy
  11. Prior receipt of SARS-CoV-2 vaccine

Sites / Locations

  • University of Arkansas for Medical Sciences
  • Scripps Health
  • University of Colorado Denver
  • MedStar Health Research Institute/MedStar Washington Hospital Center
  • Cleveland Clinic Florida
  • University of Chicago
  • Loyola University Medical Center
  • The University of Kansas Medical Center
  • Our Lady of the Lake Regional Medical Center
  • University of Maryland, Baltimore (University of Maryland Medical Center)
  • Beth Israel Deaconess Medical Center
  • Newton-Wellelsey Hospital
  • University of Minnesota
  • University of Mississippi Medical Center
  • University of New Mexico Health Sciences Center
  • University at Buffalo/Buffalo General Medical Center
  • Rochester General Hospital
  • Cleveland Clinic Ohio
  • The Ohio State University Wexner Medical Center and James Cancer Hospital
  • Vanderbilt University Medical Center
  • Meharry Medical College
  • Utah Valley Hospital
  • University of Utah Health
  • Sentara Norfolk General Hospital
  • Virginia Commonwealth University
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

pathogen reduced SARS-CoV-2 convalescent plasma

Placebo

Arm Description

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.

Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.

Outcomes

Primary Outcome Measures

COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death

Secondary Outcome Measures

All-location, All-cause 14-day Mortality
All-location, all-cause 14-day mortality; mortality was assessed via EHR review, phone call, social media review
All-location, All-cause 28-day Mortality
All-location, all-cause 28-day mortality
Survival Through 28 Days
Number of participants survived through Day 28
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death
Oxygen-free Days Through Day 28
Number of days without use of oxygen
Ventilator-free Days Through Day 28
Number of days without use of a ventilator
Vasopressor-free Days Through Day 28
Number of days without use of vasopressors
ICU-free Days Through Day 28
Number of days outside of ICU
Hospital-free Days Through Day 28
Number of days outside of the hospital

Full Information

First Posted
April 21, 2020
Last Updated
October 6, 2022
Sponsor
Vanderbilt University Medical Center
Collaborators
Dolly Parton, National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT04362176
Brief Title
Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults
Acronym
PassItOn
Official Title
Passive Immunity Trial for Our Nation (PassItOn)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 24, 2020 (Actual)
Primary Completion Date
July 6, 2021 (Actual)
Study Completion Date
August 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Dolly Parton, National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Coronavirus, SARS-CoV-2
Keywords
COVID-19 drug treatment, convalescent plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
974 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pathogen reduced SARS-CoV-2 convalescent plasma
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Intervention Type
Biological
Intervention Name(s)
pathogen reduced SARS-CoV-2 convalescent plasma
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Lactated Ringer's solution with multivitamins
Primary Outcome Measure Information:
Title
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
Description
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death
Time Frame
Study Day 15
Secondary Outcome Measure Information:
Title
All-location, All-cause 14-day Mortality
Description
All-location, all-cause 14-day mortality; mortality was assessed via EHR review, phone call, social media review
Time Frame
Baseline to Study Day 14
Title
All-location, All-cause 28-day Mortality
Description
All-location, all-cause 28-day mortality
Time Frame
Baseline to Study Day 28
Title
Survival Through 28 Days
Description
Number of participants survived through Day 28
Time Frame
Baseline to Day 28 (assessed on Study Day 29)
Title
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3
Description
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death
Time Frame
Baseline to Study Day 3
Title
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8
Description
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death
Time Frame
Study Day 8
Title
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29
Description
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: Not hospitalized with resumption of normal activities. Not hospitalized, but unable to resume normal activities. Hospitalized, not on supplemental oxygen. Hospitalized, on supplemental oxygen. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both Hospitalized, on ECMO, invasive mechanical ventilation, or both. Death
Time Frame
Study Day 29
Title
Oxygen-free Days Through Day 28
Description
Number of days without use of oxygen
Time Frame
Baseline to Day 28
Title
Ventilator-free Days Through Day 28
Description
Number of days without use of a ventilator
Time Frame
Baseline to Day 28
Title
Vasopressor-free Days Through Day 28
Description
Number of days without use of vasopressors
Time Frame
Baseline to Day 28
Title
ICU-free Days Through Day 28
Description
Number of days outside of ICU
Time Frame
Baseline to Day 28
Title
Hospital-free Days Through Day 28
Description
Number of days outside of the hospital
Time Frame
Baseline to Day 28
Other Pre-specified Outcome Measures:
Title
Acute Kidney Injury
Description
Number of participants with Acute kidney injury
Time Frame
Baseline to Day 28
Title
Renal Replacement Therapy
Description
Number of participants requiring renal replacement therapy
Time Frame
Baseline to Day 28
Title
Documented Venous Thromboembolic Disease (DVT or PE)
Description
Number of participants with documented venous thromboembolic disease (DVT or PE)
Time Frame
Baseline to Day 28
Title
Documented Cardiovascular Event (Myocardial Infarction or Ischemic Stroke)
Description
Number of Participants with myocardial infarction or ischemic stroke
Time Frame
Baseline to Day 28
Title
Transfusion Reaction
Description
Number of participants with transfusion reaction (fever/rash)
Time Frame
Baseline to Day 28
Title
Transfusion Related Acute Lung Injury (TRALI)
Description
Number of participants with transfusion related acute lung injury (TRALI)
Time Frame
Baseline to Day 28
Title
Transfusion Associated Circulatory Overload (TACO)
Description
Number of participants with transfusion associated circulatory overload (TACO)
Time Frame
Baseline to Day 28
Title
Transfusion Related Infection
Description
Number of participants with transfusion related infection
Time Frame
Baseline to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 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 Chills, or a fever (greater than 37.5° C or 99.5° F) 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 Laboratory-confirmed SARS-CoV-2 infection within the past 14 days Exclusion Criteria: Prisoner Unable to randomize within 14 days after onset of acute respiratory infection symptoms 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.) Inability to be contacted on Day 29-36 for clinical outcome assessment Receipt of any SARS-CoV-2 passive immunity therapy, such as convalescent plasma, monoclonal antibodies, or pooled immunoglobulin, in the past 30 days Contraindications to transfusion or history of prior reactions to transfused blood products Plan for hospital discharge within 24 hours of enrollment Previous enrollment in this trial Previous laboratory-confirmed SARS-CoV-2 infection before the current illness Enrollment in another clinical trial evaluating monoclonal antibodies, convalescent plasma, or another passive immunity therapy Prior receipt of SARS-CoV-2 vaccine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Rice, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Scripps Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
MedStar Health Research Institute/MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Our Lady of the Lake Regional Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
University of Maryland, Baltimore (University of Maryland Medical Center)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Newton-Wellelsey Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
012462
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
University at Buffalo/Buffalo General Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Cleveland Clinic Ohio
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Wexner Medical Center and James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
Utah Valley Hospital
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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https://www-biorxiv-org.proxy.library.vanderbilt.edu/content/10.1101/2020.01.22.914952v2
Description
Discovery of a novel coronavirus associated with the recent pneumonia outbreak in humans and its potential bat origin
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http://www.xinhuanet.com/english/2020-02/28/c_138828177.htm
Description
China puts 245 COVID-19 patients on convalescent plasma therapy - Xinhua
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Elevated Serum IgM Levels Indicate Poor Outcome in Patients with Coronavirus Disease 2019 Pneumonia: A Retrospective Case-Control Study. Rochester, NY: Social Science Research Network
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https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/recommendations-investigational-covid-19-convalescent-plasma
Description
FDA Recommendations for Investigational COVID-19 Convalescent Plasma
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https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus/en/
Description
WHO | Coronavirus disease (COVID-2019) R&D

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

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