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Completed

NCT Number: NCT04397757

COVID-19 Convalescent Plasma for the Treatment of Hospitalized Patients With Pneumonia Caused by SARS-CoV-2.

The purpose of this study is to see if this plasma can be safely used in humans with COVID-19 and to see if it improves patients' health as compared to not using it in patients with pneumonia caused by SARS-CoV-2.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

This open-label, randomized, controlled, phase 1 trial will assess the safety and efficacy of convalescent plasma in severely ill, hospitalized participants with pneumonia due to COVID-19. This study will enroll adults 18 years old and older, including pregnant women.

A total of 80 eligible participants will be randomized to receive either 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 and standard of care (treatment arm) or standard of care alone (control arm). Participants in the treatment arm will receive 2 units of convalescent plasma on Study Day 1 in addition to standard of care.

Participants will be assessed on study Day 1 (pre-dose), 30 minutes after each unit of plasma, on all Study Days while hospitalized, and Study Days 15, 22, 29, and 60. All participants will undergo a series of safety and efficacy, assessments. Blood samples will be collected on Days 1 (prior to plasma administration), 3, 8, 15, 29, and 60. Oropharyngeal or endotracheal samples will be collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, and 15.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult ≥18 years of age
  • Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other authorized or approved assay in any specimen collected within 72 hours prior to enrollment.

Note - An exception must be requested to the Sponsor if ≥72 hours since positive test.

  • Hospitalized in participating facility.
  • Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
  • Abnormal respiratory status that is judged worse than baseline by the investigator and as documented at any point within 24 hours prior to randomization, consistent with ordinal scale levels 5, 6 or 7, specifically defined as:
  • Room air saturation of oxygen (SaO2) < 93%, OR
  • Requiring supplemental oxygen, OR
  • Tachypnea with respiratory rate ≥30
  • Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements

Exclusion criteria

  • Contraindication to transfusion (e.g., severe volume overload, history of severe allergic reaction to blood products), as judged by the investigator.
  • Clinical suspicion that the etiology of acute illness (acute decompensation) is primarily due to a condition other than COVID-19
  • Receipt of other investigational therapy as a part of another clinical trial. Note: investigational therapies used as part of clinical care, (eg, remdesivir, hydroxychloroquine) are permissible.

Treatment and study plan

COVID-19 Convalescent Plasma

Biological

2 units of COVID-19 convalescent plasma compatible with their blood type

Primary outcomes

  1. Participants With Serious Adverse Events.

    Time frame: Up to Study Day 29

    Number of participants with at least one serious adverse events (SAEs) up to Study Day 29.

  2. Clinical Severity Score

    Time frame: Up to Study Day 29

    Clinical Severity Score (CSC) measured by both survival time, time to recovery (defined by reaching levels 1-3 of the WHO modified 8-Point Ordinal Severity scale), and disease course while hospitalized and is calculated based on a procedure proposed by Shaw and Fay 2016 (https://doi.org/10.1002/sim.6950). CSC ranges from 1 to 57. Higher CSC is worse outcome.

    Clinical status assessment (WHO modified 8-Point Ordinal Severity scale) includes:

    • Not hospitalized, no limitations on activities.
    • Not hospitalized, limitation on activities and/or requiring home oxygen;
    • Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;
    • Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
    • Hospitalized, requiring supplemental oxygen;
    • Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    • Hospitalized, on invasive mechanical ventilation or ECMO;
    • Death

Secondary outcomes

  1. Clinical Status Assessment, Time to Recovery

    Time frame: Up to Study Day 29

    Time to recovery, defined by time needed to reach levels 1-3 using the WHO modified 8-Point Ordinal Severity scale assessed daily while hospitalized and on Day 15, 22, and 29:

    • Not hospitalized, no limitations on activities.
    • Not hospitalized, limitation on activities and/or requiring home oxygen;
    • Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;
    • Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
    • Hospitalized, requiring supplemental oxygen;
    • Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    • Hospitalized, on invasive mechanical ventilation or ECMO;
    • Death

  2. National Early Warning Score (NEWS) Clinical Status Assessment

    Time frame: Up to Study Day 29

    Time to discharge or to a National Early Warning Score (NEWS) of ≤ 2 and maintained for 24 hours, whichever occurs first. NEWS assessed daily while hospitalized until discharge or death and on Days 15 and 29.

    Higher NEWS is worse, range from 0 to 20.

  3. Oxygenation

    Time frame: Daily while hospitalized and up to Study Day 29

    Days of supplemental oxygen while in hospital. defined as days with WHO8 ordinal score of 5, 6, or 7

  4. Incidence of New Oxygenation Use up to Day 29

    Time frame: From enrollment to Day 29.

    Incidence of new oxygenation use up to Day 29.

  5. Duration of New Oxygen Use up to Day 29

    Time frame: From enrollment to Day 29.

    Duration (days) of new oxygen use up to Day 29.

  6. Non-invasive Ventilation/High Flow Oxygen Days up to Day 29

    Time frame: Daily while in hospital to Study Day 29.

    Days of non-invasive ventilation/high flow oxygen up to Day 29 Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices

  7. Number of Participants With at Least One Day on Non-invasive Ventilation/High Flow Oxygen up to Day 29

    Time frame: Daily while in hospital until Study Day 29

    number of participants with at least one day on non-invasive ventilation/high flow oxygen Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices

  8. Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29

    Time frame: Daily while in hospital to Study Day 29.

    Days of non-invasive ventilation/high flow oxygen up to Day 29

  9. Ventilator/ECMO Days to Day 29

    Time frame: Daily while in hospital to Study Day 29

    Days of mechanical ventilation or ECMO use (having a WHO8 ordinal score of 7 = Hospitalized, on invasive mechanical ventilation or ECMO) during the study in hospital until study day 29.

  10. New Mechanical Ventilation or ECMO Use

    Time frame: From enrollment to Day 29.

    number of subjects with new mechanical ventilation or ECMO use up to Day 29 since all subjects were not on mechanical ventilation or ECMO at baseline.

  11. Duration of New Mechanical Ventilation or ECMO

    Time frame: Daily while in hospital to Study Day 29

    Days of new mechanical ventilation or ECMO use up to Day 29.

  12. Duration of Hospitalization

    Time frame: To Study Day 29

    Duration (days) of first hospitalization. Time until death or discharge or Study Day 29

  13. Mortality

    Time frame: 28 days from Study Day 1

    28 day mortality.

  14. Number of Subjects With SAEs Through Day 29

    Time frame: Through Study Day 29

    Number of subjects with SAEs through Day 29.

  15. Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29

    Time frame: Through Study Day 29

    Number of subjects with at least one Grade 3 or Grade 4 clinical and/or laboratory adverse events (AEs) through Day 29.

  16. Changes in WBC With Differential Through Day 29

    Time frame: Through Day 29

    Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value.

  17. Changes in Hemoglobin Measurement Through Day 29

    Time frame: Through Day 29

    Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value.

  18. Changes in Platelets Measurement Through Day 29

    Time frame: Through Day 29.

    Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value.

  19. Changes in Creatinine Measurement Through Day 29

    Time frame: Through Day 29.

    Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value.

  20. Changes in Glucose Measurement Through Day 29

    Time frame: Through Day 29.

    Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value.

  21. Changes in Total Bilirubin Measurement Through Day 29

    Time frame: Through Day 29

    Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value.

  22. Changes in ALT Measurement Through Day 29

    Time frame: Through Day 29

    Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value.

  23. Changes in AST Measurement Through Day 29

    Time frame: Through Day 29.

    Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value.

  24. Changes in PT Measurement Laboratory Through Day 29

    Time frame: Through Day 29.

    Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value > baseline lab value.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

An Open-Label, Controlled, Phase 1, Safety and Exploratory Efficacy Study of Convalescent Plasma for Severely Ill, Hospitalized Participants With COVID-19 Pneumonia Caused by SARS-CoV-2.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 21, 2020
Registry last updated
Apr 19, 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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