COVID-19 Convalescent Plasma for Mechanically Ventilated Population

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT04388527
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arm: 1
• Actual Duration (Months): 9
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Apr 30, 2020
• Actual Primary Completion Date: Jan 25, 2021
• Actual Study Completion Date: Jan 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Participants With Serious Adverse Events. [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. [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 [Up to Study Day 29]

   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

2. Clinical Status Assessment Using the National Early Warning Score (NEWS) of Convalescent Plasma Administration [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 [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 [From enrollment to Day 29.]

   Days of new oxygen use up to Day 29.

5. Oxygenation [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. [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. [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. [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 [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. [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. [From enrollment to Day 29.]

    Days of new mechanical ventilation or ECMO use up to Day 29.

12. Duration of Hospitalization [To Study Day 29]

    Duration (days) of first hospitalization. Time until death or discharge or Study Day 29

13. Mortality [28 days from Study Day 1]

    28 day mortality

14. Serious Adverse Events (SAEs) Through Day 29 of Convalescent Plasma Administration. [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. [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. [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. [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. [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. [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. [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. [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. [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. [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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Katharine J. Bar, MD, University of Pennsylvania

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 28, 2020

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04388527
• Other Study ID Numbers: 842996 (PennCCP-01)
• First Posted: May 14, 2020
• Last Update Posted: Apr 4, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

Participant Flow

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Period Title: Overall Study
STARTED	32
COMPLETED	15
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Overall Participants	32
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	23 71.9%
>=65 years	9 28.1%
Sex: Female, Male (Count of Participants)
Female	16 50%
Male	16 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 12.5%
Not Hispanic or Latino	26 81.3%
Unknown or Not Reported	2 6.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	19 59.4%
White	10 31.3%
More than one race	0 0%
Unknown or Not Reported	3 9.4%
Region of Enrollment (participants) [Number]
United States	32 100%

Outcome Measures

1. Primary Outcome

Title	Participants With Serious Adverse Events.
Description	Cumulative incidence of participants with at least one serious adverse events (SAEs) at Study Day 29.
Time Frame	Up to Study Day 29

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Count of Participants [Participants]	22 68.8%

2. Primary Outcome

Title	Time to Clinical Improvement.
Description	Time to removal from mechanical ventilation.
Time Frame	Up to Study Day 29

Outcome Measure Data

Analysis Population Description

excludes those without improvement (were still on mechanical ventilation or died before removal of invasive mechanical ventilation/ECMO)

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	15
Median (Inter-Quartile Range) [Days]	11

3. Secondary Outcome

Title	Clinical Status Assessment, Using 8-point Ordinal Scale, of Convalescent Plasma Administration
Description	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
Time Frame	Up to Study Day 29

Outcome Measure Data

Analysis Population Description

excludes those without improvement (WHO8 score of 6,7,or 8)

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	12
Median (Inter-Quartile Range) [days]	12.5

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

excludes 20 subjects who have outcome measure of Infinity as they were never discharged or never had NEWS <=2 while in hospital by Study Day 29

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	12
Median (Inter-Quartile Range) [days]	10

5. Secondary Outcome

Title	Incidence of New Oxygenation Use up to Day 29 of Convalescent Plasma Administration
Description	Incidence of new oxygenation use up to Day 29.
Time Frame	From enrollment to Day 29.

Outcome Measure Data

Analysis Population Description

this endpoint was not measured due to redundancy

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	0

6. Secondary Outcome

Title	Duration of New Oxygen Use up to Day 29 of Convalescent Plasma Administration
Description	Days of new oxygen use up to Day 29.
Time Frame	From enrollment to Day 29.

Outcome Measure Data

Analysis Population Description

this endpoint was not measured due to redundancy

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	0

7. Secondary Outcome

Title	Oxygenation
Description	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.
Time Frame	Daily while hospitalized up to Study Day 29.

Outcome Measure Data

Analysis Population Description

All 32 enrolled subjects were evaluated for days of oxygenation.

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Median (Inter-Quartile Range) [days]	16

8. Secondary Outcome

Title	Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 of Convalescent Plasma Administration.
Description	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
Time Frame	Daily while in hospital to Study Day 29.

Outcome Measure Data

Analysis Population Description

All 32 enrolled subjects were evaluated. Subjects who never had a WHO8 ordinal score of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices have a measured outcome of 0 days.

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Median (Inter-Quartile Range) [days]	0

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Count of Participants [Participants]	13 40.6%

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

this endpoint was not measured due to redundancy with other endpoints (#8)

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	0

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Median (Inter-Quartile Range) [days]	11.5

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Endpoint was not well defined as all subjects started on mechanical ventilation

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	0

13. Secondary Outcome

Title	Duration of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration.
Description	Days of new mechanical ventilation or ECMO use up to Day 29.
Time Frame	From enrollment to Day 29.

Outcome Measure Data

Analysis Population Description

Endpoint was not well defined as all subjects started on mechanical ventilation

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	0

14. Secondary Outcome

Title	Duration of Hospitalization
Description	Duration (days) of first hospitalization. Time until death or discharge or Study Day 29
Time Frame	To Study Day 29

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Median (Inter-Quartile Range) [days]	20

15. Secondary Outcome

Title	Mortality
Description	28 day mortality
Time Frame	28 days from Study Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Count of Participants [Participants]	14 43.8%

16. Secondary Outcome

Title	Serious Adverse Events (SAEs) Through Day 29 of Convalescent Plasma Administration.
Description	subjects with Serious Adverse Events (SAEs) through Day 29.
Time Frame	Through Study Day 29.

Outcome Measure Data

Analysis Population Description

.this endpoint is redundant with the primary endpoint

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	0

17. Secondary Outcome

Title	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.
Description	Number of subjects with at least one Grade 3 or Grade 4 clinical and/or laboratory adverse events through Day 29.
Time Frame	Through Study Day 29

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Count of Participants [Participants]	32 100%

18. Secondary Outcome

Title	Changes in WBC With Differential Through Day 29 of Convalescent Plasma Administration.
Description	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.
Time Frame	Through Day 29.

Outcome Measure Data

Analysis Population Description

Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Median (Inter-Quartile Range) [THO/uL]	1.25

19. Secondary Outcome

Title	Changes in Hemoglobin Measurement Through Day 29 of Convalescent Plasma Administration.
Description	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.
Time Frame	Through Day 29.

Outcome Measure Data

Analysis Population Description

Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Median (Inter-Quartile Range) [g/dL]	-0.65

20. Secondary Outcome

Title	Changes in Platelets Measurement Through Day 29 of Convalescent Plasma Administration.
Description	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.
Time Frame	Through Day 29.

Outcome Measure Data

Analysis Population Description

Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Median (Inter-Quartile Range) [10^3 platelets per uL]	24

21. Secondary Outcome

Title	Changes in Creatinine Measurement Through Day 29 of Convalescent Plasma Administration.
Description	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.
Time Frame	Through Day 29.

Outcome Measure Data

Analysis Population Description

Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Median (Inter-Quartile Range) [mg/dL]	-0.39

22. Secondary Outcome

Title	Changes in Glucose Measurement Through Day 29 of Convalescent Plasma Administration.
Description	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.
Time Frame	Through Day 29.

Outcome Measure Data

Analysis Population Description

Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Median (Inter-Quartile Range) [mg/dL]	-36.00

23. Secondary Outcome

Title	Changes in Total Bilirubin Measurement Through Day 29 of Convalescent Plasma Administration.
Description	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.
Time Frame	Through Day 29.

Outcome Measure Data

Analysis Population Description

Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Median (Inter-Quartile Range) [mg/dL]	0.00

24. Secondary Outcome

Title	Changes in ALT Measurement Through Day 29 of Convalescent Plasma Administration.
Description	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.
Time Frame	Through Day 29.

Outcome Measure Data

Analysis Population Description

Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Median (Inter-Quartile Range) [U/L]	-3.00

25. Secondary Outcome

Title	Changes in AST Measurement Through Day 29 of Convalescent Plasma Administration.
Description	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.
Time Frame	Through Day 29

Outcome Measure Data

Analysis Population Description

Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	32
Median (Inter-Quartile Range) [U/L]	-7.50

26. Secondary Outcome

Title	Changes in PT Measurement Through Day 29 of Convalescent Plasma Administration.
Description	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.
Time Frame	Through Day 29

Outcome Measure Data

Analysis Population Description

Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects. analyzed sample size is 30 because 2 subjects did not have PT lab collected.

Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Measure Participants	30
Median (Inter-Quartile Range) [seconds]	-0.050

Adverse Events

Time Frame	Up to 65 days after receiving investigational product
Arm/Group Title	Treatment
Arm/Group Description	Penn COVID-19 convalescent plasma COVID-19 Convalescent Plasma: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
All Cause Mortality
	Treatment
	Affected / at Risk (%)	# Events
Total	14/32 (43.8%)
Serious Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	23/32 (71.9%)
Cardiac disorders
Arrhythmia (by ECG or physical examination)	2/32 (6.3%)	2
Metabolism and nutrition disorders
Acidosis	1/32 (3.1%)	1
Nervous system disorders
Acute CNS Ischemia	2/32 (6.3%)	2
Psychiatric disorders
Altered mental status	1/32 (3.1%)	1
Renal and urinary disorders
Creatinine Clearance Low	1/32 (3.1%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea or Respiratory Distress	13/32 (40.6%)	16
Vascular disorders
Hemorrhage (with significant acute blood loss)	2/32 (6.3%)	2
Hypotension	6/32 (18.8%)	6
Embolism	1/32 (3.1%)	1
Other (Not Including Serious) Adverse Events
	Treatment
	Affected / at Risk (%)	# Events
Total	32/32 (100%)
Blood and lymphatic system disorders
Hemoglobin, Low (g/dL; mmol/L) >= 13 years of age (female only)	10/32 (31.3%)	14
Platelets, Decreased	6/32 (18.8%)	8
Hemorrhage (with significant acute blood loss)	2/32 (6.3%)	2
Hemoglobin, Low (g/dL; mmol/L) >= 13 years of age (male only)	20/32 (62.5%)	39
Cardiac disorders
Arrhythmia	13/32 (40.6%)	19
General disorders
Fever (non-axillary temperatures only)	7/32 (21.9%)	8
Investigations
ALT, High	3/32 (9.4%)	4
AST, High	3/32 (9.4%)	3
Creatinine, High	7/32 (21.9%)	9
Lactate, High	2/32 (6.3%)	2
Metabolism and nutrition disorders
Acidosis	9/32 (28.1%)	13
Albumin, Low	5/32 (15.6%)	6
Alkalosis	4/32 (12.5%)	5
Calcium, Low	4/32 (12.5%)	6
Glucose (mg/dL; mmol/L) Fasting, High	8/32 (25%)	8
Sodium, High	7/32 (21.9%)	10
Nervous system disorders
Altered Mental Status	5/32 (15.6%)	5
Renal and urinary disorders
Hematuria	2/32 (6.3%)	2
Vascular disorders
Blood Pressure Abnormalities Hypertension (with the lowest reading taken after repeat testing durin	8/32 (25%)	14
Hypotension	8/32 (25%)	13
Thrombosis or Embolism	4/32 (12.5%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.