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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04362176
Other study ID # 200738
Secondary ID 3UL1TR002243-04S
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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, 

References & Publications (50)

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* Note: There are 50 references in allClick 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
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