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

Phase 3

Completed

• Conditions: COVID-19; Coronavirus; SARS-CoV-2
• Interventions: Biological: pathogen reduced SARS-CoV-2 convalescent plasma; Biological: Placebo

• Registration Number: NCT04362176
• Lead Sponsor: 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-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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-23
• Study Start: 2020-04-24
• Study First Posted: 2020-04-24
• Primary Completion: 2021-07-06
• Study Completion: 2021-08-06
• Results First Submitted: 2022-07-06
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-06
• Last Update Submitted: 2022-10-06
• Results First Posted: 2022-11-03
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 974

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pathogen reduced SARS-CoV-2 convalescent plasma	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.
Placebo	Placebo	Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.

Primary Outcome Measures

Name	Time	Method
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score	Study Day 15	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: 1. Not hospitalized with resumption of normal activities.; 2. Not hospitalized, but unable to resume normal activities.; 3. Hospitalized, not on supplemental oxygen.; 4. Hospitalized, on supplemental oxygen.; 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both.; 7. Death

Secondary Outcome Measures

Name	Time	Method
Survival Through 28 Days	Baseline to Day 28 (assessed on Study Day 29)	Number of participants survived through Day 28
All-location, All-cause 14-day Mortality	Baseline to Study Day 14	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	Baseline to Study Day 28	All-location, all-cause 28-day mortality
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3	Baseline to 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: 1. Not hospitalized with resumption of normal activities.; 2. Not hospitalized, but unable to resume normal activities.; 3. Hospitalized, not on supplemental oxygen.; 4. Hospitalized, on supplemental oxygen.; 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both.; 7. Death
Hospital-free Days Through Day 28	Baseline to Day 28	Number of days outside of the hospital
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29	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: 1. Not hospitalized with resumption of normal activities.; 2. Not hospitalized, but unable to resume normal activities.; 3. Hospitalized, not on supplemental oxygen.; 4. Hospitalized, on supplemental oxygen.; 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both.; 7. Death
Oxygen-free Days Through Day 28	Baseline to Day 28	Number of days without use of oxygen
Ventilator-free Days Through Day 28	Baseline to Day 28	Number of days without use of a ventilator
Vasopressor-free Days Through Day 28	Baseline to Day 28	Number of days without use of vasopressors
ICU-free Days Through Day 28	Baseline to Day 28	Number of days outside of ICU
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8	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: 1. Not hospitalized with resumption of normal activities.; 2. Not hospitalized, but unable to resume normal activities.; 3. Hospitalized, not on supplemental oxygen.; 4. Hospitalized, on supplemental oxygen.; 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both.; 7. Death

Trial Locations

Locations (26)

Our Lady of the Lake Regional Medical Center; 🇺🇸 Baton Rouge, Louisiana, United States

University of Maryland, Baltimore (University of Maryland Medical Center); 🇺🇸 Baltimore, Maryland, United States

Meharry Medical College; 🇺🇸 Nashville, Tennessee, United States

University of Utah Health; 🇺🇸 Salt Lake City, Utah, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Scripps Health; 🇺🇸 La Jolla, California, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

University of New Mexico Health Sciences Center; 🇺🇸 Albuquerque, New Mexico, United States

Newton-Wellelsey Hospital; 🇺🇸 Newton, Massachusetts, United States

Cleveland Clinic Ohio; 🇺🇸 Cleveland, Ohio, United States

University at Buffalo/Buffalo General Medical Center; 🇺🇸 Buffalo, New York, United States

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States

Utah Valley Hospital; 🇺🇸 Provo, Utah, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

The Ohio State University Wexner Medical Center and James Cancer Hospital; 🇺🇸 Columbus, Ohio, United States

MedStar Health Research Institute/MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Rochester General Hospital; 🇺🇸 Rochester, New York, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States