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

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04362176
• Collaborator: Dolly Parton (Other), National Center for Advancing Translational Science (NCATS) (NIH)
• Enrollment: 974
• Locations: 26
• Arms: 2
• Actual Duration (Months): 15.4
• Patients Per Site: 37.5
• Patients Per Site Per Month: 2.4

Study Details

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.

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 974 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.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: Apr 24, 2020
• Actual Primary Completion Date: Jul 6, 2021
• Actual Study Completion Date: Aug 6, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. COVID-19 7-point Ordinal Clinical Progression Outcomes Scale [Study Day 15]

   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

1. All-location, all-cause 14-day mortality [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 [Baseline to Study Day 28 (assessed on Study Day 29)]

   All-location, all-cause 28-day mortality

3. Survival through 28 days [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 [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 [Baseline to Study Day 3]

   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

6. COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 [Study Day 8]

   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

7. COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 [Study Day 29]

   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

8. Oxygen-free days through Day 28 [Baseline to Day 28]

   Number of days without use of oxygen

9. Ventilator-free days through Day 28 [Baseline to Day 28]

   Number of days without use of a ventilator

10. Vasopressor-free days through Day 28 [Baseline to Day 28]

    Number of days without use of vasopressors

11. ICU-free days through Day 28 [Baseline to Day 28]

    Number of days outside of ICU

12. Hospital-free days through Day 28 [Baseline to Day 28]

    Number of days outside of the hospital

Other Outcome Measures

1. Acute kidney injury [Baseline to Day 28]

   Number of participants with Acute kidney injury

2. Renal replacement therapy [Baseline to Day 28]

   Number of participants requiring renal replacement therapy

3. Documented venous thromboembolic disease (DVT or PE) [Baseline to Day 28]

   Number of participants with documented venous thromboembolic disease (DVT or PE)

4. Documented cardiovascular event (myocardial infarction or ischemic stroke) [Baseline to Day 28]

   Number of Participants with myocardial infarction or ischemic stroke

5. Transfusion reaction [Baseline to Day 28]

   Number of participants with transfusion reaction (fever/rash)

6. Transfusion related acute lung injury (TRALI) [Baseline to Day 28]

   Number of participants with transfusion related acute lung injury (TRALI)

7. Transfusion associated circulatory overload (TACO) [Baseline to Day 28]

   Number of participants with transfusion associated circulatory overload (TACO)

8. Transfusion related infection [Baseline to Day 28]

   Number of participants with transfusion related infection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

4. Cough

5. Chills, or a fever (greater than 37.5° C or 99.5° F)

6. Shortness of breath, operationalized as a patient having any of the following:

1. 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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
2	Scripps Health	La Jolla	California	United States	92037
3	University of Colorado Denver	Aurora	Colorado	United States	80045
4	MedStar Health Research Institute/MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
5	Cleveland Clinic Florida	Weston	Florida	United States	33331
6	University of Chicago	Chicago	Illinois	United States	60637
7	Loyola University Medical Center	Maywood	Illinois	United States	60153
8	The University of Kansas Medical Center	Kansas City	Kansas	United States	66160
9	Our Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana	United States	70808
10	University of Maryland, Baltimore (University of Maryland Medical Center)	Baltimore	Maryland	United States	21201
11	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
12	Newton-Wellelsey Hospital	Newton	Massachusetts	United States	012462
13	University of Minnesota	Minneapolis	Minnesota	United States	55455
14	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
15	University of New Mexico Health Sciences Center	Albuquerque	New Mexico	United States	87131
16	University at Buffalo/Buffalo General Medical Center	Buffalo	New York	United States	14203
17	Rochester General Hospital	Rochester	New York	United States	14621
18	Cleveland Clinic Ohio	Cleveland	Ohio	United States	44195
19	The Ohio State University Wexner Medical Center and James Cancer Hospital	Columbus	Ohio	United States	43210
20	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37203
21	Meharry Medical College	Nashville	Tennessee	United States	37208
22	Utah Valley Hospital	Provo	Utah	United States	84604
23	University of Utah Health	Salt Lake City	Utah	United States	84132
24	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
25	Virginia Commonwealth University	Richmond	Virginia	United States	23298
26	University of Washington	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Vanderbilt University Medical Center
• Dolly Parton
• National Center for Advancing Translational Science (NCATS)

Investigators

• Principal Investigator: Todd Rice, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

• Informed Consent Form - Nov 4, 2020

More Information

Additional Information:

• Discovery of a novel coronavirus associated with the recent pneumonia outbreak in humans and its potential bat origin
• China puts 245 COVID-19 patients on convalescent plasma therapy - Xinhua
• 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
• FDA Recommendations for Investigational COVID-19 Convalescent Plasma
• WHO | Coronavirus disease (COVID-2019) R&D

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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
• First Posted: Apr 24, 2020
• Last Update Posted: Nov 4, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Todd Rice, Associate Professor of Medicine, Vanderbilt University Medical Center: COVID-19 drug treatment; convalescent plasma
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Nov 4, 2021