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

COVID-19 Clinical Trial

— PassItOn  

Official title:

Passive Immunity Trial for Our Nation (PassItOn)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04362176
• Other study ID #: 200738
• Secondary ID: 3UL1TR002243-04S
• Status: Completed
• Phase: Phase 3
• Start date: April 24, 2020
• Est. completion date: August 6, 2021

Study information

• Verified date: October 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 974
• Est. completion date: August 6, 2021
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• SARS-CoV-2

Intervention

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
Lactated Ringer's solution with multivitamins

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	University of Colorado Denver	Aurora	Colorado
United States	University of Maryland, Baltimore (University of Maryland Medical Center)	Baltimore	Maryland
United States	Our Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University at Buffalo/Buffalo General Medical Center	Buffalo	New York
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic Ohio	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center and James Cancer Hospital	Columbus	Ohio
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	Scripps Health	La Jolla	California
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Minnesota	Minneapolis	Minnesota
United States	Meharry Medical College	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Newton-Wellelsey Hospital	Newton	Massachusetts
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Utah Valley Hospital	Provo	Utah
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Rochester General Hospital	Rochester	New York
United States	University of Utah Health	Salt Lake City	Utah
United States	University of Washington	Seattle	Washington
United States	MedStar Health Research Institute/MedStar Washington Hospital Center	Washington	District of Columbia
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Dolly Parton, National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute Kidney Injury	Number of participants with Acute kidney injury	Baseline to Day 28
Other	Renal Replacement Therapy	Number of participants requiring renal replacement therapy	Baseline to Day 28
Other	Documented Venous Thromboembolic Disease (DVT or PE)	Number of participants with documented venous thromboembolic disease (DVT or PE)	Baseline to Day 28
Other	Documented Cardiovascular Event (Myocardial Infarction or Ischemic Stroke)	Number of Participants with myocardial infarction or ischemic stroke	Baseline to Day 28
Other	Transfusion Reaction	Number of participants with transfusion reaction (fever/rash)	Baseline to Day 28
Other	Transfusion Related Acute Lung Injury (TRALI)	Number of participants with transfusion related acute lung injury (TRALI)	Baseline to Day 28
Other	Transfusion Associated Circulatory Overload (TACO)	Number of participants with transfusion associated circulatory overload (TACO)	Baseline to Day 28
Other	Transfusion Related Infection	Number of participants with transfusion related infection	Baseline to Day 28
Primary	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	Study Day 15
Secondary	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	Baseline to Study Day 14
Secondary	All-location, All-cause 28-day Mortality	All-location, all-cause 28-day mortality	Baseline to Study Day 28
Secondary	Survival Through 28 Days	Number of participants survived through Day 28	Baseline to Day 28 (assessed on Study Day 29)
Secondary	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	Baseline to Study Day 3
Secondary	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	Study Day 8
Secondary	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	Study Day 29
Secondary	Oxygen-free Days Through Day 28	Number of days without use of oxygen	Baseline to Day 28
Secondary	Ventilator-free Days Through Day 28	Number of days without use of a ventilator	Baseline to Day 28
Secondary	Vasopressor-free Days Through Day 28	Number of days without use of vasopressors	Baseline to Day 28
Secondary	ICU-free Days Through Day 28	Number of days outside of ICU	Baseline to Day 28
Secondary	Hospital-free Days Through Day 28	Number of days outside of the hospital	Baseline to Day 28

External Links

•   China puts 245 COVID-19 patients on convalescent plasma therapy - Xinhua
•   Discovery of a novel coronavirus associated with the recent pneumonia outbreak in humans and its potential bat origin
•   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