Clinical trial NCT04362176: Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults
Official title: Passive Immunity Trial for Our Nation (PassItOn)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Coronavirus
SARS-CoV-2
Keywords: COVID-19 drug treatment
convalescent plasma
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Dolly Parton
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2020-04-24
Enrollment: 974
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
timeFrame: Study Day 15
Secondary outcomes:
measure: All-location, All-cause 14-day Mortality
timeFrame: Baseline to Study Day 14
measure: All-location, All-cause 28-day Mortality
timeFrame: Baseline to Study Day 28
measure: Survival Through 28 Days
timeFrame: Baseline to Day 28 (assessed on Study Day 29)
measure: COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3
timeFrame: Baseline to Study Day 3
measure: COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8
timeFrame: Study Day 8
measure: COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29
timeFrame: Study Day 29
measure: Oxygen-free Days Through Day 28
timeFrame: Baseline to Day 28
measure: Ventilator-free Days Through Day 28
timeFrame: Baseline to Day 28
measure: Vasopressor-free Days Through Day 28
timeFrame: Baseline to Day 28
measure: ICU-free Days Through Day 28
timeFrame: Baseline to Day 28
measure: Hospital-free Days Through Day 28
timeFrame: Baseline to Day 28
Other outcomes:
measure: Acute Kidney Injury
timeFrame: Baseline to Day 28
measure: Renal Replacement Therapy
timeFrame: Baseline to Day 28
measure: Documented Venous Thromboembolic Disease (DVT or PE)
timeFrame: Baseline to Day 28
measure: Documented Cardiovascular Event (Myocardial Infarction or Ischemic Stroke)
timeFrame: Baseline to Day 28
measure: Transfusion Reaction
timeFrame: Baseline to Day 28
measure: Transfusion Related Acute Lung Injury (TRALI)
timeFrame: Baseline to Day 28
measure: Transfusion Associated Circulatory Overload (TACO)
timeFrame: Baseline to Day 28
measure: Transfusion Related Infection
timeFrame: Baseline to Day 28
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Washington
country: United States
facility: MedStar Health Research Institute/MedStar Washington Hospital Center
state: District of Columbia
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland, Baltimore (University of Maryland Medical Center)
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Newton
country: United States
facility: Newton-Wellelsey Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Buffalo
country: United States
facility: University at Buffalo/Buffalo General Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Ohio
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center and James Cancer Hospital
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Provo
country: United States
facility: Utah Valley Hospital
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Vanderbilt University Medical Center
name: Todd Rice, MD
role: PRINCIPAL_INVESTIGATOR
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