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COVID-19 Convalescent Plasma for Mechanically Ventilated Population

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ClinicalTrials.gov Identifier: NCT04388527
Recruitment Status : Recruiting
First Posted : May 14, 2020
Last Update Posted : September 17, 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

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 29 days from treatment. ]
    Cumulative incidence of serious adverse events (SAEs) at Study Day 29.

  2. Time to clinical improvement. [ Time Frame: Up to 60 days from receiving treatment. ]
    Survival and time to clinical improvement as measured by removal from mechanical ventilation.


Secondary Outcome Measures :
  1. Clinical status assessment, using 8-point ordinal scale, of convalescent plasma administration as compared to placebo recipients in DMID Protocol Number: 20-0006. [ Time Frame: From enrollment, daily while hospitalized until discharge or death and on Days 15, 22, and 29. ]
    Time to improvement of one category and two categories from Day 1.

  2. Clinical status assessment using the National Early Warning Score (NEWS) of convalescent plasma administration as compared to placebo recipients in DMID Protocol Number: 20-0006. [ 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. Incidence of new oxygenation use up to Day 29 of convalescent plasma administration as compared to placebo recipients in DMID Protocol Number: 20-0006. [ 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 as compared to placebo recipients in DMID Protocol Number: 20-0006. [ Time Frame: From enrollment to Day 29. ]
    Days of new oxygen use up to Day 29.

  5. Oxygen-free days of convalescent plasma administration as compared to placebo recipients in DMID Protocol Number: 20-0006. [ Time Frame: From enrollment to Day 29. ]
    Oxygen-free days to Day 29.

  6. Non-invasive ventilation/high flow oxygen days up to Day 29 of convalescent plasma administration as compared to placebo recipients in DMID Protocol Number: 20-0006. [ 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 as compared to placebo recipients in DMID Protocol Number: 20-0006. [ 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 as compared to placebo recipients in DMID Protocol Number: 20-0006. [ 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 as compared to placebo recipients in DMID Protocol Number: 20-0006. [ 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 as compared to placebo recipients in DMID Protocol Number: 20-0006. [ 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 as compared to placebo recipients in DMID Protocol Number: 20-0006. [ 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 as compared to placebo recipients in DMID Protocol Number: 20-0006 [ Time Frame: To Day 29. ]
    Duration of hospitalization.

  13. Mortality of convalescent plasma administration as compared to placebo recipients in DMID Protocol Number: 20-0006 [ Time Frame: To Day 28. ]
    D14 and D28 mortality.

  14. Cumulative incidence of SAEs through Day 29 of convalescent plasma administration as compared to matched participants from the control arm of DMID Protocol No. 20-0006. [ 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 as compared to matched participants from the control arm of DMID Protocol No. 20-0006. [ 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 as compared to matched participants from the control arm of DMID Protocol No. 20-0006. [ 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 as compared to matched participants from the control arm of DMID Protocol No. 20-0006. [ 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 as compared to matched participants from the control arm of DMID Protocol No. 20-0006.. [ 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 as compared to matched participants from the control arm of DMID Protocol No. 20-0006.. [ 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 as compared to matched participants from the control arm of DMID Protocol No. 20-0006. [ 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 as compared to matched participants form the control arm of DMID Protocol No. 20-0006.. [ 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 as compared to matched participants from the control arm of DMID Protocol No. 20-0006. [ 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 as compared to matched participants from the control arm of DMID Protocol No. 20-0006. [ 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 as compared to matched participants from the control arm of DMID Protocol No. 20-0006. [ 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).



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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, 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


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, MD University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04388527    
Other Study ID Numbers: 842996 (PennCCP-01)
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No