Passive Immunity Trial of Nashville II for COVID-19


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 Ordinal Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.

Full Title of Study: “A Randomized, Controlled Clinical Trial to Test the Safety and Efficacy of Convalescent Donor Plasma to Treat COVID-19 in Hospitalized Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: April 2021

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 0. 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.


  • 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.
  • Biological: Placebo
    • Lactated Ringer’s solution with multivitamins

Arms, Groups and Cohorts

  • 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.
  • Placebo Comparator: Placebo
    • Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.

Clinical Trial Outcome Measures

Primary Measures

  • COVID Ordinal Outcomes Scale:Day 15
    • Time Frame: Study Day 15
    • Death Hospitalized on invasive mechanical ventilation or ECMO Hospitalized on non-invasive ventilation or high flow nasal cannula Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with limitation in activity (continued symptoms) Not hospitalized without limitation in activity (no symptoms)

Secondary Measures

  • All-location, all-cause 14-day mortality
    • Time Frame: Baseline to Study Day 14
    • All-location, all-cause 14-day mortality
  • All-location, all-cause 28-day mortality
    • Time Frame: Baseline to Study Day 28
    • All-location, all-cause 28-day mortality
  • COVID Ordinal Outcomes Scale Day 3
    • Time Frame: Baseline to Study Day 3
    • Death Hospitalized on invasive mechanical ventilation or ECMO Hospitalized on non-invasive ventilation or high flow nasal cannula Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with limitation in activity (continued symptoms) Not hospitalized without limitation in activity (no symptoms)
  • COVID Ordinal Outcomes Scale Day 8
    • Time Frame: Study Day 8
    • Death Hospitalized on invasive mechanical ventilation or ECMO Hospitalized on non-invasive ventilation or high flow nasal cannula Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with limitation in activity (continued symptoms) Not hospitalized without limitation in activity (no symptoms)
  • COVID Ordinal Outcomes Scale Day 29
    • Time Frame: Study Day 29
    • Death Hospitalized on invasive mechanical ventilation or ECMO Hospitalized on non-invasive ventilation or high flow nasal cannula Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with limitation in activity (continued symptoms) Not hospitalized without limitation in activity (no symptoms)
  • Composite of death or receipt of ECMO through Day 28
    • Time Frame: Baseline to Day 28
    • Number of participants that died or received ECMO
  • Oxygen-free days through Day 28
    • Time Frame: Baseline to Day 28
    • Number of days without use of oxygen
  • Vasopressor-free days through Day 28
    • Time Frame: Baseline to Day 28
    • Number of days without use of vasopressors
  • Ventilator-free days through Day 28
    • Time Frame: Baseline to Day 28
    • Number of days without use of a ventilator
  • ICU-free days through Day 28
    • Time Frame: Baseline to Day 28
    • Number of days outside of ICU
  • Hospital-free days through Day 28
    • Time Frame: Baseline to Day 28
    • Number of days outside of the hospital

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥18 years
  • Currently hospitalized or in an emergency department with anticipated hospitalization.
  • Symptoms of acute respiratory infection, defined as one or more of the following: cough, fever (> 37.5° C / 99.5° F), shortness of breath
  • Laboratory-confirmed SARS-CoV-2 infection within the past 10 days

Exclusion Criteria

  • Prisoner
  • Unable to randomize within 14 days after onset of acute respiratory infection symptoms
  • Unable to randomize within 48 hours after hospital arrival
  • Inability to be contacted on Day 29-36 for clinical outcome assessment
  • Receipt of pooled immunoglobulin in the past 30 days
  • Contraindications to transfusion or history of prior reactions to transfusion blood products
  • Previous enrollment in this trial

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University Medical Center
  • Collaborator
    • Dolly Parton
  • Provider of Information About this Clinical Study
    • Principal Investigator: Todd Rice, Associate Professor of Medicine – Vanderbilt University Medical Center
  • Overall Official(s)
    • Todd Rice, MD, Principal Investigator, Vanderbilt University Medical Center
  • Overall Contact(s)
    • Amanda J Bistran-Hall, (615) 875-8531,


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