Covid-19Phase 1NCT04388527
COVID-19 Convalescent Plasma for Mechanically Ventilated Population
A Phase 1 study testing COVID-19 Convalescent Plasma in people with Covid-19, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- COVID-19 Convalescent Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2020to 30 Jan 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
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.
Read the 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.
- Conditions
- Covid-19
- Being tested
- COVID-19 Convalescent Plasma
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 Convalescent PlasmaBiological
Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Penn COVID-19 convalescent plasma Receives: Biological: COVID-19 Convalescent Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Serious Adverse Events.
Cumulative incidence of participants with at least one serious adverse events (SAEs) at Study Day 29.
Measured: Up to Study Day 29
Time to Clinical Improvement.
Time to removal from mechanical ventilation.
Measured: Up to Study Day 29
Secondary outcomes (24)
Clinical Status Assessment, Using 8-point Ordinal Scale, of Convalescent Plasma Administration
Time to improvement by at least 2 category from Day 1 (time to reach WHO8 <=5). WHO8 score:
- 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
Measured: Up to Study Day 29
Clinical Status Assessment Using the National Early Warning Score (NEWS) of Convalescent Plasma Administration
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.
Measured: Up to Study Day 29
Incidence of New Oxygenation Use up to Day 29 of Convalescent Plasma Administration
Incidence of new oxygenation use up to Day 29.
Measured: From enrollment to Day 29.
Duration of New Oxygen Use up to Day 29 of Convalescent Plasma Administration
Days of new oxygen use up to Day 29.
Measured: From enrollment to Day 29.
Oxygenation
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.
Measured: Daily while hospitalized up to Study Day 29.
Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 of Convalescent Plasma Administration.
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
Measured: 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.
Number of subjects with at least one day of non-invasive ventilation (WHO8 ordinal score of 6) while in hospital
Measured: Daily while in hospital to Study Day 29.
Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration.
Days of non-invasive ventilation/high flow oxygen up to Day 29.
Measured: Daily while in hospital to Study Day 29.
Invasive Ventilation/ Extracorporeal Membrane Oxygenation(ECMO) Days
Days on Invasive Ventilator/ECMO defined as WHO8 ordinal score of 7 = Hospitalized, on invasive mechanical ventilation or ECMO
Measured: Daily while in hospital to Study Day 29
Incidence of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration.
Incidence of new mechanical ventilation or ECMO use up to Day 29.
Measured: From enrollment to Day 29.
Duration of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration.
Days of new mechanical ventilation or ECMO use up to Day 29.
Measured: From enrollment to Day 29.
Duration of Hospitalization
Duration (days) of first hospitalization. Time until death or discharge or Study Day 29
Measured: To Study Day 29
Mortality
28 day mortality
Measured: 28 days from Study Day 1
Serious Adverse Events (SAEs) Through Day 29 of Convalescent Plasma Administration.
subjects with Serious Adverse Events (SAEs) through Day 29.
Measured: 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.
Number of subjects with at least one Grade 3 or Grade 4 clinical and/or laboratory adverse events through Day 29.
Measured: Through Study Day 29
Changes in WBC With Differential Through Day 29 of Convalescent Plasma Administration.
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.
Measured: Through Day 29.
Changes in Hemoglobin Measurement Through Day 29 of Convalescent Plasma Administration.
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.
Measured: Through Day 29.
Changes in Platelets Measurement Through Day 29 of Convalescent Plasma Administration.
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.
Measured: Through Day 29.
Changes in Creatinine Measurement Through Day 29 of Convalescent Plasma Administration.
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.
Measured: Through Day 29.
Changes in Glucose Measurement Through Day 29 of Convalescent Plasma Administration.
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.
Measured: Through Day 29.
Changes in Total Bilirubin Measurement Through Day 29 of Convalescent Plasma Administration.
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.
Measured: Through Day 29.
Changes in ALT Measurement Through Day 29 of Convalescent Plasma Administration.
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.
Measured: Through Day 29.
Changes in AST Measurement Through Day 29 of Convalescent Plasma Administration.
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.
Measured: Through Day 29
Changes in PT Measurement Through Day 29 of Convalescent Plasma Administration.
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.
Measured: Through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start30 Apr 2020
- Primary completion25 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katharine J. Bar, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388527
- Sponsor's protocol ID
- 842996 (PennCCP-01)
- Status last verified
- Mar 2022
- First submitted
- 4 May 2020
- Last updated
- 4 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04388527
- Acronym / sponsor ID
- 842996 (PennCCP-01)
- Conditions
- Covid-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Posted 4 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: COVID-19 Convalescent PlasmaPenn COVID-19 convalescent plasma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 Convalescent PlasmaParticipants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19. | Biological | Treatment |
Primary outcome
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.
Time to Clinical Improvement.
Time frame: Up to Study Day 29
Time to removal from mechanical ventilation.
24 secondary outcomes
Clinical Status Assessment, Using 8-point Ordinal Scale, of Convalescent Plasma Administration
Time frame: 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
Incidence of New Oxygenation Use up to Day 29 of Convalescent Plasma Administration
Time frame: 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.
Oxygenation
Time frame: 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.
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.
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.
Invasive Ventilation/ Extracorporeal Membrane Oxygenation(ECMO) Days
Time frame: 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.
Duration of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration.
Time frame: From enrollment to Day 29.
Duration of Hospitalization
Time frame: To Study Day 29
Mortality
Time frame: 28 days from Study Day 1
Serious Adverse Events (SAEs) Through Day 29 of Convalescent Plasma Administration.
Time frame: 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
Changes in WBC With Differential Through Day 29 of Convalescent Plasma Administration.
Time frame: Through Day 29.
Changes in Hemoglobin Measurement Through Day 29 of Convalescent Plasma Administration.
Time frame: Through Day 29.
Changes in Platelets Measurement Through Day 29 of Convalescent Plasma Administration.
Time frame: Through Day 29.
Changes in Creatinine Measurement Through Day 29 of Convalescent Plasma Administration.
Time frame: Through Day 29.
Changes in Glucose Measurement Through Day 29 of Convalescent Plasma Administration.
Time frame: Through Day 29.
Changes in Total Bilirubin Measurement Through Day 29 of Convalescent Plasma Administration.
Time frame: Through Day 29.
Changes in ALT Measurement Through Day 29 of Convalescent Plasma Administration.
Time frame: Through Day 29.
Changes in AST Measurement Through Day 29 of Convalescent Plasma Administration.
Time frame: Through Day 29
Changes in PT Measurement Through Day 29 of Convalescent Plasma Administration.
Time frame: Through Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharine J. Bar, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COVID-19 Convalescent Plasma in people with Covid-19, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Serious Adverse Events. (time frame: Up to Study Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.