Trial Outcomes & Findings for COVID-19 Convalescent Plasma for Mechanically Ventilated Population (NCT NCT04388527)

NCT ID: NCT04388527

Last Updated: 2022-04-04

Results Overview

Cumulative incidence of participants with at least one serious adverse events (SAEs) at Study Day 29.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 32 participants
• Primary outcome timeframe: Up to Study Day 29
• Results posted on: 2022-04-04

Participant Flow

Participant milestones

Measure	Treatment 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 Study STARTED	32
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	Treatment 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 Study Death	14
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

COVID-19 Convalescent Plasma for Mechanically Ventilated Population

Baseline characteristics by cohort

Measure	Treatment n=32 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Study Day 29

Cumulative incidence of participants with at least one serious adverse events (SAEs) at Study Day 29.

Outcome measures

Measure	Treatment n=32 Participants 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.
Participants With Serious Adverse Events.	22 Participants

PRIMARY outcome

Timeframe: Up to Study Day 29

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

Time to removal from mechanical ventilation.

Outcome measures

Measure	Treatment n=15 Participants 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.
Time to Clinical Improvement.	11 Days Interval 5.0 to 15.5

SECONDARY outcome

Timeframe: Up to Study Day 29

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

Time to improvement by at least 2 category from Day 1 (time to reach WHO8 <=5). WHO8 score:

1. Not hospitalized, no limitations on activities.

2. Not hospitalized, limitation on activities and/or requiring home oxygen;

3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;

4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);

5. Hospitalized, requiring supplemental oxygen;

6. Hospitalized, on non-invasive ventilation or high flow oxygen devices;

7. Hospitalized, on invasive mechanical ventilation or ECMO;

8. Death

Outcome measures

Measure	Treatment n=12 Participants 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.
Clinical Status Assessment, Using 8-point Ordinal Scale, of Convalescent Plasma Administration	12.5 days Interval 6.0 to 16.25

SECONDARY outcome

Timeframe: Up to Study Day 29

Population: 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

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.

Outcome measures

Measure	Treatment n=12 Participants 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.
Clinical Status Assessment Using the National Early Warning Score (NEWS) of Convalescent Plasma Administration	10 days Interval 6.0 to 17.5

SECONDARY outcome

Timeframe: From enrollment to Day 29.

Population: this endpoint was not measured due to redundancy

Incidence of new oxygenation use up to Day 29.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From enrollment to Day 29.

Population: this endpoint was not measured due to redundancy

Days of new oxygen use up to Day 29.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Daily while hospitalized up to Study Day 29.

Population: All 32 enrolled subjects were evaluated for days of 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.

Outcome measures

Measure	Treatment n=32 Participants 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.
Oxygenation	16 days Interval 7.0 to 23.0

SECONDARY outcome

Timeframe: Daily while in hospital to Study Day 29.

Population: 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.

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

Outcome measures

Measure	Treatment n=32 Participants 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.
Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 of Convalescent Plasma Administration.	0 days Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Treatment n=32 Participants 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.
Number of Subjects With at Least One Day of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration.	13 Participants

SECONDARY outcome

Timeframe: Daily while in hospital to Study Day 29.

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

Days of non-invasive ventilation/high flow oxygen up to Day 29.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Treatment n=32 Participants 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.
Invasive Ventilation/ Extracorporeal Membrane Oxygenation(ECMO) Days	11.5 days Interval 5.75 to 19.25

SECONDARY outcome

Timeframe: From enrollment to Day 29.

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From enrollment to Day 29.

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: To Study Day 29

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

Outcome measures

Measure	Treatment n=32 Participants 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.
Duration of Hospitalization	20 days Interval 9.5 to 26.5

SECONDARY outcome

Timeframe: 28 days from Study Day 1

28 day mortality

Outcome measures

Measure	Treatment n=32 Participants 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.
Mortality	14 Participants

SECONDARY outcome

Timeframe: Through Study Day 29.

Population: .this endpoint is redundant with the primary endpoint

subjects with Serious Adverse Events (SAEs) through Day 29.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=32 Participants 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.
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.	32 Participants

SECONDARY outcome

Timeframe: Through Day 29.

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

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.

Outcome measures

Measure	Treatment n=32 Participants 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.
Changes in WBC With Differential Through Day 29 of Convalescent Plasma Administration.	1.25 THO/uL Interval -4.4 to 7.0

SECONDARY outcome

Timeframe: Through Day 29.

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

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.

Outcome measures

Measure	Treatment n=32 Participants 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.
Changes in Hemoglobin Measurement Through Day 29 of Convalescent Plasma Administration.	-0.65 g/dL Interval -2.4 to 0.475

SECONDARY outcome

Timeframe: Through Day 29.

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

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.

Outcome measures

Measure	Treatment n=32 Participants 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.
Changes in Platelets Measurement Through Day 29 of Convalescent Plasma Administration.	24 10^3 platelets per uL Interval -105.75 to 90.0

SECONDARY outcome

Timeframe: Through Day 29.

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

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.

Outcome measures

Measure	Treatment n=32 Participants 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.
Changes in Creatinine Measurement Through Day 29 of Convalescent Plasma Administration.	-0.39 mg/dL Interval -1.505 to -0.01

SECONDARY outcome

Timeframe: Through Day 29.

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

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.

Outcome measures

Measure	Treatment n=32 Participants 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.
Changes in Glucose Measurement Through Day 29 of Convalescent Plasma Administration.	-36.00 mg/dL Interval -81.5 to -2.25

SECONDARY outcome

Timeframe: Through Day 29.

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

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.

Outcome measures

Measure	Treatment n=32 Participants 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.
Changes in Total Bilirubin Measurement Through Day 29 of Convalescent Plasma Administration.	0.00 mg/dL Interval -0.1 to 0.225

SECONDARY outcome

Timeframe: Through Day 29.

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

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.

Outcome measures

Measure	Treatment n=32 Participants 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.
Changes in ALT Measurement Through Day 29 of Convalescent Plasma Administration.	-3.00 U/L Interval -20.25 to 17.5

SECONDARY outcome

Timeframe: Through Day 29

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

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.

Outcome measures

Measure	Treatment n=32 Participants 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.
Changes in AST Measurement Through Day 29 of Convalescent Plasma Administration.	-7.50 U/L Interval -33.0 to 1.75

SECONDARY outcome

Timeframe: Through Day 29

Population: 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.

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.

Outcome measures

Measure	Treatment n=30 Participants 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.
Changes in PT Measurement Through Day 29 of Convalescent Plasma Administration.	-0.050 seconds Interval -2.95 to 1.075

Adverse Events

Treatment

Serious events: 23 serious events

Other events: 32 other events

Deaths: 14 deaths

Serious adverse events

Measure	Treatment n=32 participants at risk 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.
Nervous system disorders Acute CNS Ischemia	6.2% 2/32 • Number of events 2 • Up to 65 days after receiving investigational product
Metabolism and nutrition disorders Acidosis	3.1% 1/32 • Number of events 1 • Up to 65 days after receiving investigational product
Cardiac disorders Arrhythmia (by ECG or physical examination)	6.2% 2/32 • Number of events 2 • Up to 65 days after receiving investigational product
Renal and urinary disorders Creatinine Clearance Low	3.1% 1/32 • Number of events 1 • Up to 65 days after receiving investigational product
Respiratory, thoracic and mediastinal disorders Dyspnea or Respiratory Distress	40.6% 13/32 • Number of events 16 • Up to 65 days after receiving investigational product
Vascular disorders Hemorrhage (with significant acute blood loss)	6.2% 2/32 • Number of events 2 • Up to 65 days after receiving investigational product
Vascular disorders Hypotension	18.8% 6/32 • Number of events 6 • Up to 65 days after receiving investigational product
Vascular disorders Embolism	3.1% 1/32 • Number of events 1 • Up to 65 days after receiving investigational product
Psychiatric disorders Altered mental status	3.1% 1/32 • Number of events 1 • Up to 65 days after receiving investigational product

Other adverse events

Measure	Treatment n=32 participants at risk 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.
Metabolism and nutrition disorders Acidosis	28.1% 9/32 • Number of events 13 • Up to 65 days after receiving investigational product
Metabolism and nutrition disorders Albumin, Low	15.6% 5/32 • Number of events 6 • Up to 65 days after receiving investigational product
Metabolism and nutrition disorders Alkalosis	12.5% 4/32 • Number of events 5 • Up to 65 days after receiving investigational product
Investigations ALT, High	9.4% 3/32 • Number of events 4 • Up to 65 days after receiving investigational product
Nervous system disorders Altered Mental Status	15.6% 5/32 • Number of events 5 • Up to 65 days after receiving investigational product
Cardiac disorders Arrhythmia	40.6% 13/32 • Number of events 19 • Up to 65 days after receiving investigational product
Investigations AST, High	9.4% 3/32 • Number of events 3 • Up to 65 days after receiving investigational product
Vascular disorders Blood Pressure Abnormalities Hypertension (with the lowest reading taken after repeat testing durin	25.0% 8/32 • Number of events 14 • Up to 65 days after receiving investigational product
Metabolism and nutrition disorders Calcium, Low	12.5% 4/32 • Number of events 6 • Up to 65 days after receiving investigational product
Investigations Creatinine, High	21.9% 7/32 • Number of events 9 • Up to 65 days after receiving investigational product
General disorders Fever (non-axillary temperatures only)	21.9% 7/32 • Number of events 8 • Up to 65 days after receiving investigational product
Metabolism and nutrition disorders Glucose (mg/dL; mmol/L) Fasting, High	25.0% 8/32 • Number of events 8 • Up to 65 days after receiving investigational product
Renal and urinary disorders Hematuria	6.2% 2/32 • Number of events 2 • Up to 65 days after receiving investigational product
Blood and lymphatic system disorders Hemoglobin, Low (g/dL; mmol/L) >= 13 years of age (female only)	31.2% 10/32 • Number of events 14 • Up to 65 days after receiving investigational product
Vascular disorders Hypotension	25.0% 8/32 • Number of events 13 • Up to 65 days after receiving investigational product
Investigations Lactate, High	6.2% 2/32 • Number of events 2 • Up to 65 days after receiving investigational product
Blood and lymphatic system disorders Platelets, Decreased	18.8% 6/32 • Number of events 8 • Up to 65 days after receiving investigational product
Metabolism and nutrition disorders Sodium, High	21.9% 7/32 • Number of events 10 • Up to 65 days after receiving investigational product
Vascular disorders Thrombosis or Embolism	12.5% 4/32 • Number of events 5 • Up to 65 days after receiving investigational product
Blood and lymphatic system disorders Hemorrhage (with significant acute blood loss)	6.2% 2/32 • Number of events 2 • Up to 65 days after receiving investigational product
Blood and lymphatic system disorders Hemoglobin, Low (g/dL; mmol/L) >= 13 years of age (male only)	62.5% 20/32 • Number of events 39 • Up to 65 days after receiving investigational product

Additional Information

Regulatory Lead

University of Pennsylvania

Phone: 512-662-4484

Email: psom-ind-ide@pobox.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place