We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

COVID-19 Convalescent Plasma for Mechanically Ventilated Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04388527
Recruitment Status : Completed
First Posted : May 14, 2020
Results First Posted : April 4, 2022
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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 can improve patients' health when they are sick with COVID-19.

Condition or disease Intervention/treatment Phase
Covid-19 Biological: COVID-19 Convalescent Plasma Phase 1

Detailed Description:
This open-label, single arm, phase 1 trial will assess the safety and efficacy of convalescent plasma in severely ill, mechanically ventilated participants with pneumonia due to COVID-19. This study will enroll adults 18 years old and older, including pregnant women. A total of 50 eligible participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19. Participants will receive convalescent plasma on Study Day 1 in addition to standard of care. Participants will be assessed daily while hospitalized and then on Study Days 15, 22, 29, and 60. All participants will undergo a series of safety, efficacy, and laboratory assessments. Blood samples will be collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, 15, 29, and 60. Oropharyngeal or endotracheal samples will be collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, and 15.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single Arm, Phase 1, Safety and Exploratory Efficacy Study of Convalescent Plasma for Severely Ill Mechanically Ventilated Participants With COVID-19 Caused by SARS-CoV-2
Actual Study Start Date : April 30, 2020
Actual Primary Completion Date : January 25, 2021
Actual Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Penn COVID-19 convalescent plasma
Biological: COVID-19 Convalescent Plasma
Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.




Primary Outcome Measures :
  1. Participants With Serious Adverse Events. [ Time Frame: Up to Study Day 29 ]
    Cumulative incidence of participants with at least one serious adverse events (SAEs) at Study Day 29.

  2. Time to Clinical Improvement. [ Time Frame: Up to Study Day 29 ]
    Time to removal from mechanical ventilation.


Secondary Outcome Measures :
  1. Clinical Status Assessment, Using 8-point Ordinal Scale, of Convalescent Plasma Administration [ Time Frame: Up to Study Day 29 ]

    Time to improvement by at least 2 category from Day 1 (time to reach WHO8 <=5). WHO8 score:

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

  2. Clinical Status Assessment Using the National Early Warning Score (NEWS) of Convalescent Plasma Administration [ Time Frame: Up to Study Day 29 ]

    Time to discharge or to a 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. Incidence of New Oxygenation Use up to Day 29 of Convalescent Plasma Administration [ Time Frame: From enrollment to Day 29. ]
    Incidence of new oxygenation use up to Day 29.

  4. Duration of New Oxygen Use up to Day 29 of Convalescent Plasma Administration [ Time Frame: From enrollment to Day 29. ]
    Days of new oxygen use up to Day 29.

  5. Oxygenation [ Time Frame: Daily while hospitalized up to Study Day 29. ]
    Days of supplemental oxygen while in hospital up to Study Day 29. In hospital supplemental oxygen days counted as days with a WHO8 ordinal score of 5, 6, or 7.

  6. Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 of Convalescent Plasma Administration. [ Time Frame: Daily while in hospital to Study Day 29. ]
    Days of non-invasive ventilation/high flow oxygen while in hospital up to Day 29, defined as having WHO8 ordinal score of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices

  7. Number of Subjects With at Least One Day of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration. [ Time Frame: Daily while in hospital to Study Day 29. ]
    Number of subjects with at least one day of non-invasive ventilation (WHO8 ordinal score of 6) while in hospital

  8. Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration. [ Time Frame: Daily while in hospital to Study Day 29. ]
    Days of non-invasive ventilation/high flow oxygen up to Day 29.

  9. Invasive Ventilation/ Extracorporeal Membrane Oxygenation(ECMO) Days [ Time Frame: Daily while in hospital to Study Day 29 ]
    Days on Invasive Ventilator/ECMO defined as WHO8 ordinal score of 7 = Hospitalized, on invasive mechanical ventilation or ECMO

  10. Incidence of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration. [ Time Frame: From enrollment to Day 29. ]
    Incidence of new mechanical ventilation or ECMO use up to Day 29.

  11. Duration of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration. [ Time Frame: From enrollment to 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. Serious Adverse Events (SAEs) Through Day 29 of Convalescent Plasma Administration. [ Time Frame: Through Study Day 29. ]
    subjects with Serious Adverse Events (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 of Convalescent Plasma Administration. [ Time Frame: Through Study Day 29 ]
    Number of subjects with at least one Grade 3 or Grade 4 clinical and/or laboratory adverse events through Day 29.

  16. Changes in WBC With Differential Through Day 29 of Convalescent Plasma Administration. [ 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 of Convalescent Plasma Administration. [ 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 of Convalescent Plasma Administration. [ 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 of Convalescent Plasma Administration. [ 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 of Convalescent Plasma Administration. [ 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 of Convalescent Plasma Administration. [ 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 of Convalescent Plasma Administration. [ 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 of Convalescent Plasma Administration. [ 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 Through Day 29 of Convalescent Plasma Administration. [ 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult ≥18 years of age
  2. 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.
  3. Hospitalized, on invasive mechanical ventilation or ECMO, consistent with a clinical status assessment 8-point ordinal scale severity score of 7.
  4. Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
  5. Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388527


Locations
Layout table for location information
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Katharine J. Bar, MD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04388527    
Other Study ID Numbers: 842996 (PennCCP-01)
First Posted: May 14, 2020    Key Record Dates
Results First Posted: April 4, 2022
Last Update Posted: April 4, 2022
Last Verified: March 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases