- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04388527
COVID-19 Convalescent Plasma for Mechanically Ventilated Population
March 31, 2022 updated by: University of Pennsylvania
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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, on invasive mechanical ventilation or ECMO, consistent with a clinical status assessment 8-point ordinal scale severity score of 7.
- Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).
- 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. a. Note: investigational therapies used as part of clinical care, (eg, remdesivir, hydroxychloroquine) are permissible.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
Penn COVID-19 convalescent plasma
|
Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to Study Day 29
|
Time to Clinical Improvement.
Time Frame: Up to Study Day 29
|
Time to removal from mechanical ventilation.
|
Up to Study Day 29
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
Up to Study Day 29
|
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. |
Up to Study Day 29
|
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.
|
From enrollment to Day 29.
|
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.
|
From enrollment to Day 29.
|
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.
|
Daily while hospitalized up to Study Day 29.
|
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
|
Daily while in hospital to Study Day 29.
|
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
|
Daily while in hospital to Study Day 29.
|
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.
|
Daily while in hospital to Study Day 29.
|
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
|
Daily while in hospital to Study Day 29
|
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.
|
From enrollment to Day 29.
|
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.
|
From enrollment to Day 29.
|
Duration of Hospitalization
Time Frame: To Study Day 29
|
Duration (days) of first hospitalization.
Time until death or discharge or Study Day 29
|
To Study Day 29
|
Mortality
Time Frame: 28 days from Study Day 1
|
28 day mortality
|
28 days from Study Day 1
|
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.
|
Through Study Day 29.
|
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.
|
Through Study Day 29
|
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.
|
Through Day 29.
|
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.
|
Through Day 29.
|
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.
|
Through Day 29.
|
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.
|
Through Day 29.
|
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.
|
Through Day 29.
|
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.
|
Through Day 29.
|
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.
|
Through Day 29.
|
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.
|
Through Day 29
|
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.
|
Through Day 29
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Katharine J. Bar, MD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2020
Primary Completion (Actual)
January 25, 2021
Study Completion (Actual)
January 30, 2021
Study Registration Dates
First Submitted
May 4, 2020
First Submitted That Met QC Criteria
May 12, 2020
First Posted (Actual)
May 14, 2020
Study Record Updates
Last Update Posted (Actual)
April 4, 2022
Last Update Submitted That Met QC Criteria
March 31, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 842996 (PennCCP-01)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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