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Completed

NCT Number: NCT04362176

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater than or equal to 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
  • Chills, or a fever (greater than 37.5° C or 99.5° F)
  • 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

  • Laboratory-confirmed SARS-CoV-2 infection within the past 14 days

Exclusion criteria

  • Prisoner
  • Unable to randomize within 14 days after onset of acute respiratory infection symptoms
  • 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.)
  • Inability to be contacted on Day 29-36 for clinical outcome assessment
  • Receipt of any SARS-CoV-2 passive immunity therapy, such as convalescent plasma, monoclonal antibodies, or pooled immunoglobulin, in the past 30 days
  • Contraindications to transfusion or history of prior reactions to transfused blood products
  • Plan for hospital discharge within 24 hours of enrollment
  • Previous enrollment in this trial
  • Previous laboratory-confirmed SARS-CoV-2 infection before the current illness
  • Enrollment in another clinical trial evaluating monoclonal antibodies, convalescent plasma, or another passive immunity therapy
  • Prior receipt of SARS-CoV-2 vaccine

Treatment and study plan

pathogen reduced SARS-CoV-2 convalescent plasma

Biological

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

Biological

Lactated Ringer's solution with multivitamins

Primary outcomes

  1. COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score

    Time frame: 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:

    • 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

Secondary outcomes

  1. All-location, All-cause 14-day Mortality

    Time frame: Baseline to Study Day 14

    All-location, all-cause 14-day mortality; mortality was assessed via EHR review, phone call, social media review

  2. All-location, All-cause 28-day Mortality

    Time frame: Baseline to Study Day 28

    All-location, all-cause 28-day mortality

  3. Survival Through 28 Days

    Time frame: Baseline to Day 28 (assessed on Study Day 29)

    Number of participants survived through Day 28

  4. COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3

    Time frame: 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:

    • 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

  5. COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8

    Time frame: 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

  6. COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29

    Time frame: 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

  7. Oxygen-free Days Through Day 28

    Time frame: Baseline to Day 28

    Number of days without use of oxygen

  8. Ventilator-free Days Through Day 28

    Time frame: Baseline to Day 28

    Number of days without use of a ventilator

  9. Vasopressor-free Days Through Day 28

    Time frame: Baseline to Day 28

    Number of days without use of vasopressors

  10. ICU-free Days Through Day 28

    Time frame: Baseline to Day 28

    Number of days outside of ICU

  11. Hospital-free Days Through Day 28

    Time frame: Baseline to Day 28

    Number of days outside of the hospital

Other outcomes

  1. Acute Kidney Injury

    Time frame: Baseline to Day 28

    Number of participants with Acute kidney injury

  2. Renal Replacement Therapy

    Time frame: Baseline to Day 28

    Number of participants requiring renal replacement therapy

  3. Documented Venous Thromboembolic Disease (DVT or PE)

    Time frame: Baseline to Day 28

    Number of participants with documented venous thromboembolic disease (DVT or PE)

  4. Documented Cardiovascular Event (Myocardial Infarction or Ischemic Stroke)

    Time frame: Baseline to Day 28

    Number of Participants with myocardial infarction or ischemic stroke

  5. Transfusion Reaction

    Time frame: Baseline to Day 28

    Number of participants with transfusion reaction (fever/rash)

  6. Transfusion Related Acute Lung Injury (TRALI)

    Time frame: Baseline to Day 28

    Number of participants with transfusion related acute lung injury (TRALI)

  7. Transfusion Associated Circulatory Overload (TACO)

    Time frame: Baseline to Day 28

    Number of participants with transfusion associated circulatory overload (TACO)

  8. Transfusion Related Infection

    Time frame: Baseline to Day 28

    Number of participants with transfusion related infection

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Dolly Parton
  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Passive Immunity Trial for Our Nation (PassItOn)

Acronym: PassItOn

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2020
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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