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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04397757
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : July 10, 2020
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 improves patients' health as compared to not using it in patients with pneumonia caused by SARS-CoV-2.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized 1:1 to receive either convalescent plasma on Study Day 1 in addition to standard care or standard care alone.
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : May 13, 2020
Estimated Primary Completion Date : September 13, 2020
Estimated Study Completion Date : November 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: COVID-19 Convalescent plasma
COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
Biological: COVID-19 Convalescent Plasma
2 units of COVID-19 convalescent plasma compatible with their blood type

No Intervention: Standard care
Standard care alone



Primary Outcome Measures :
  1. Participants with serious adverse events. [ Time Frame: Up to 29 days from treatment ]
    Cumulative incidence of serious adverse events (SAEs) at Study Day 29.

  2. Comparison of clinical severity score between patients on the experimental versus control arms; [ Time Frame: Up to 29 days from treatment ]
    Severity is measured by the 8-point ordinal clinical severity scale at D29 where 1 is the best state to be in and 8 is the worst (equals death).


Secondary Outcome Measures :
  1. Clinical status assessment, using 8-point ordinal scale, of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: Up to 29 days from treatment ]
    Time to recovery, defined by time to levels 1-3 on the ordinal scale

  2. Clinical status assessment using the National Early Warning Score (NEWS) of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: From enrollment, daily while hospitalized until discharge or death and on Days 15 and 29. ]
    Time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first.

  3. Oxygen-free days of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: From enrollment to Day 29 ]
    Oxygen-free days to Day 29.

  4. Incidence of new oxygenation use up to Day 29 of convalescent plasma administration by comparing treatment vs control arms [ 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 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: From enrollment to Day 29. ]
    Days of new oxygen use up to Day 29.

  6. Non-invasive ventilation/high flow oxygen days up to Day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: From enrollment to Day 29. ]
    Days of non-invasive ventilation/high flow oxygen up to Day 29

  7. Incidence of non-invasive ventilation/high flow oxygen up to Day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: From enrollment to Day 29. ]
    Incidence of non-invasive ventilation up to Day 29.

  8. Duration of non-invasive ventilation/high flow oxygen up to Day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: From enrollment to Day 29. ]
    Days of non-invasive ventilation/high flow oxygen up to Day 29

  9. Ventilator/ECMO free days to Day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: From enrollment to Day 29. ]
    Ventilation/ECMO free days up to Day 29. mechanical ventilation or ECMO use during the study.

  10. Incidence of new mechanical ventilation or ECMO use of convalescent plasma administration by comparing treatment vs control arms [ 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 by comparing treatment vs control arms [ Time Frame: From enrollment to Day 29. ]
    Days of new mechanical ventilation or ECMO use up to Day 29.

  12. Duration of hospitalization of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: To Day 29 ]
    Duration of hospitalization.

  13. Mortality of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: To Day 28 ]
    D14 and D28 mortality.

  14. Cumulative incidence of SAEs through Day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: Through Day 29 ]
    Cumulative incidence of SAEs through Day 29.

  15. Cumulative incidence of Grade 3 and Grade 4 clinical and/or laboratory adverse events through Day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: Through Day 29 ]
    Cumulative incidence of Grade 3 and Grade 4 clinical and/or laboratory adverse events through Day 29.

  16. Changes in WBC with differential through day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: Through Day 29 ]
    Changes in WBC with differential on Days 1, 3, 5, 8, and 11 (while hospitalized); Days 15 and 29 (if attends in person visit or still hospitalized).

  17. Changes in hemoglobin measurement through Day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: Through Day 29 ]
    Changes in hemoglobin measurement on Days 1, 3, 5, 8, and 11 (while hospitalized); Days 15 and 29 (if attends in person visit or still hospitalized).

  18. Changes in platelets measurement through Day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: Through Day 29. ]
    Changes in platelets measurement laboratory adverse events on Days 1, 3, 5, 8, and 11 (while hospitalized); Days 15 and 29 (if attends in person visit or still hospitalized).

  19. Changes in creatinine measurement through Day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: Through Day 29. ]
    Changes in creatinine measurement on Days 1, 3, 5, 8, and 11 (while hospitalized); Days 15 and 29 (if attends in person visit or still hospitalized).

  20. Changes in glucose measurement through Day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: Through Day 29. ]
    Changes in glucose measurement on Days 1, 3, 5, 8, and 11 (while hospitalized); Days 15 and 29 (if attends in person visit or still hospitalized).

  21. Changes in bilirubin measurement through Day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: Through Day 29 ]
    Changes in bilirubin measurement on Days 1, 3, 5, 8, and 11 (while hospitalized); Days 15 and 29 (if attends in person visit or still hospitalized).

  22. Changes in ALT measurement laboratory adverse events through Day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: Through Day 29 ]
    Changes in ALT measurement laboratory adverse events on Days 1, 3, 5, 8, and 11 (while hospitalized); Days 15 and 29 (if attends in person visit or still hospitalized).

  23. Changes in AST measurement through Day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: Through Day 29. ]
    Changes in AST measurement on Days 1, 3, 5, 8, and 11 (while hospitalized); Days 15 and 29 (if attends in person visit or still hospitalized).

  24. Changes in PT measurement laboratory adverse events through Day 29 of convalescent plasma administration by comparing treatment vs control arms [ Time Frame: Through Day 29. ]
    Changes in PT measurement laboratory adverse events on Days 1, 3, 5, 8, and 11 (while hospitalized); Days 15 and 29 (if attends in person visit or still hospitalized).



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.


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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 in participating facility.
  4. Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
  5. 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
  6. 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. 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): NCT04397757


Contacts
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Contact: Katharine J. Bar, MD (215) 349-8092 BarK@pennmedicine.upenn.edu
Contact: Julie Starr 215-349-8527 jstarr@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Katharine J. Bar, MD    215-349-8092    BarK@pennmedicine.upenn.edu   
Contact: Julie Starr    215-349-8527    jstarr@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Katharine J. Bar University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04397757    
Other Study ID Numbers: 843003 (PennCCP-02)
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
Convalescent plasma
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections