Trial Outcomes & Findings for Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma (NCT NCT04502472)

Last Updated: 2022-01-10

Results Overview

Change is clinical status as captured by 7-point ordinal scale to include 1. Death 2. Hospitalized, requiring mechanical ventilation or ECMO 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise). 7. Not Hospitalized

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

109 participants

Primary outcome timeframe

Time of plasma infusion (day 0) compared to day 7

Results posted on

2022-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	COVID-19 Convalescent Plasma (CCP) Donors Patients recovered from COVID-19 and donated CCP through the study.	COVID-19 Convalescent Plasma (CCP Recipients) Patients who were hospitalized with COVID-19 and received CCP infusions through the study.
Overall Study STARTED	61	48
Overall Study COMPLETED	58	45
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion n=48 Participants Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria Convalescent plasma transfusion: Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.	Donor of COVID-19 Convalescent Plasma (CCP) n=61 Participants Patients who recovered from COVID-19 infection and test negative for COVID-19 by nasopharyngeal swab.	Total n=109 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	54 Participants n=7 Participants	85 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants
Age, Continuous	59 years n=5 Participants	48 years n=7 Participants	53 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	35 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	26 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	4 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	54 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	53 Participants n=7 Participants	65 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants	3 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants	61 participants n=7 Participants	109 participants n=5 Participants

PRIMARY outcome

Timeframe: Time of plasma infusion (day 0) compared to day 7

Population: Patients that were hospitalized with COVID-19 and received CCP were evaluated using the 7-point ordinal scale. The worse oxygenation status was used for day 0 and day 7.

Outcome measures

Outcome measures
Measure	Patients Hospitalized With COVID-19 n=45 Participants 45 patients were hospitalized with COVID-19 and received CCP through the study.	Patients Recovered From COVID-19 patients who donated CCP
Change is Clinical Status Average Day 7 Ordinal Scale	3.86 units on a scale Interval 1.0 to 7.0	—
Change is Clinical Status Average Day 1 Ordinal Scale	3.06 units on a scale Interval 1.0 to 7.0	—

PRIMARY outcome

Timeframe: Within 6 hours of infusion

Population: Transfusion related events were only measured in the convalescent plasma recipient arm. 48 patients were enrolled in the study. 45 received CCP. 3 patients received CCP through individual INDs. This outcome measure was only for patients who were hospitalized with COVID-19 and received CCP through the study.

Number of participants with Transfusion Related Adverse Events

Outcome measures

Outcome measures
Measure	Patients Hospitalized With COVID-19 n=45 Participants 45 patients were hospitalized with COVID-19 and received CCP through the study.	Patients Recovered From COVID-19 patients who donated CCP
Transfusion Related Events Due to Administration of CCP	3 Participants	—

SECONDARY outcome

Timeframe: Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28

Population: Patients ts that were hospitalized with COVID-19 and received CCP were evaluated using the 7-point ordinal scale. The worse oxygenation status was used for days 7, 14, 21, and 28

Change in 7-point ordinal scale score from time of plasma infusion (day 0-prior to first infusion) to days 7, 14, 21, and 28. 7 point ordinal scale: 1. Death 2. Hospitalized, requiring mechanical ventilation or ECMO 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise). 7. Not Hospitalized

Outcome measures

Outcome measures
Measure	Patients Hospitalized With COVID-19 n=45 Participants 45 patients were hospitalized with COVID-19 and received CCP through the study.	Patients Recovered From COVID-19 patients who donated CCP
Change is Clinical Status Ordinal Scale Day 0 · Ordinal Scale 6 out of 7	0 Participants	—
Change is Clinical Status Ordinal Scale Day 14 · Ordinal Scale 2 out of 7	5 Participants	—
Change is Clinical Status Ordinal Scale Day 0 · Ordinal Scale 1 out of 7	0 Participants	—
Change is Clinical Status Ordinal Scale Day 7 · Ordinal Scale 2 out of 7	11 Participants	—
Change is Clinical Status Ordinal Scale Day 0 · Ordinal Scale 2 out of 7	10 Participants	—
Change is Clinical Status Ordinal Scale Day 0 · Ordinal Scale 3 out of 7	22 Participants	—
Change is Clinical Status Ordinal Scale Day 0 · Ordinal Scale 4 out of 7	13 Participants	—
Change is Clinical Status Ordinal Scale Day 0 · Ordinal Scale 5 out of 7	0 Participants	—
Change is Clinical Status Ordinal Scale Day 0 · Ordinal Scale 7 out of 7	0 Participants	—
Change is Clinical Status Ordinal Scale Day 7 · Ordinal Scale 3 out of 7	6 Participants	—
Change is Clinical Status Ordinal Scale Day 7 · Ordinal Scale 4 out of 7	10 Participants	—
Change is Clinical Status Ordinal Scale Day 7 · Ordinal Scale 5 out of 7	1 Participants	—
Change is Clinical Status Ordinal Scale Day 7 · Ordinal Scale 6 out of 7	0 Participants	—
Change is Clinical Status Ordinal Scale Day 7 · Ordinal Scale 7 out of 7	12 Participants	—
Change is Clinical Status Ordinal Scale Day 7 · Ordinal Scale 1 out of 7	5 Participants	—
Change is Clinical Status Ordinal Scale Day 14 · Ordinal Scale 3 out of 7	3 Participants	—
Change is Clinical Status Ordinal Scale Day 14 · Ordinal Scale 4 out of 7	5 Participants	—
Change is Clinical Status Ordinal Scale Day 14 · Ordinal Scale 5 out of 7	0 Participants	—
Change is Clinical Status Ordinal Scale Day 14 · Ordinal Scale 6 out of 7	0 Participants	—
Change is Clinical Status Ordinal Scale Day 14 · Ordinal Scale 7 out of 7	21 Participants	—
Change is Clinical Status Ordinal Scale Day 14 · Ordinal Scale 1 out of 7	11 Participants	—
Change is Clinical Status Ordinal Scale Day 21 · Ordinal Scale 2 out of 7	5 Participants	—
Change is Clinical Status Ordinal Scale Day 21 · Ordinal Scale 3 out of 7	1 Participants	—
Change is Clinical Status Ordinal Scale Day 21 · Ordinal Scale 4 out of 7	3 Participants	—
Change is Clinical Status Ordinal Scale Day 21 · Ordinal Scale 5 out of 7	0 Participants	—
Change is Clinical Status Ordinal Scale Day 21 · Ordinal Scale 6 out of 7	0 Participants	—
Change is Clinical Status Ordinal Scale Day 21 · Ordinal Scale 7 out of 7	23 Participants	—
Change is Clinical Status Ordinal Scale Day 21 · Ordinal Scale 1 out of 7	13 Participants	—
Change is Clinical Status Ordinal Scale Day 28 · Ordinal Scale 2 out of 7	2 Participants	—
Change is Clinical Status Ordinal Scale Day 28 · Ordinal Scale 3 out of 7	2 Participants	—
Change is Clinical Status Ordinal Scale Day 28 · Ordinal Scale 4 out of 7	1 Participants	—
Change is Clinical Status Ordinal Scale Day 28 · Ordinal Scale 5 out of 7	0 Participants	—
Change is Clinical Status Ordinal Scale Day 28 · Ordinal Scale 6 out of 7	0 Participants	—
Change is Clinical Status Ordinal Scale Day 28 · Ordinal Scale 7 out of 7	26 Participants	—
Change is Clinical Status Ordinal Scale Day 28 · Ordinal Scale 1 out of 7	14 Participants	—

SECONDARY outcome

Timeframe: Total Index Hospitalization

Population: Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death

Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death (up to an average of 67 days)

Outcome measures

Outcome measures
Measure	Patients Hospitalized With COVID-19 n=45 Participants 45 patients were hospitalized with COVID-19 and received CCP through the study.	Patients Recovered From COVID-19 patients who donated CCP
Length of Hospital Stay	20 days Interval 4.0 to 67.0	—

SECONDARY outcome

Timeframe: Days 7, 14, 21, 28

Population: The count of participants below shows the total number of participants needing mechanical ventilation for that time point.

Number of participants that required mechanical ventilation that were not on mechanical ventilation at that time point.

Outcome measures

Outcome measures
Measure	Patients Hospitalized With COVID-19 n=45 Participants 45 patients were hospitalized with COVID-19 and received CCP through the study.	Patients Recovered From COVID-19 patients who donated CCP
Mechanical Ventilation Day 7 · Patients not requiring mechanical ventilation	17 Participants	—
Mechanical Ventilation Day 7 · Patients deceased	5 Participants	—
Mechanical Ventilation Day 21 · Patients not requiring mechanical ventilation	4 Participants	—
Mechanical Ventilation Day 21 · Patients deceased	13 Participants	—
Mechanical Ventilation Day 7 · Patients requiring mechanical ventilation	11 Participants	—
Mechanical Ventilation Day 7 · Patients discharged	12 Participants	—
Mechanical Ventilation Day 14 · Patients requiring mechanical ventilation	5 Participants	—
Mechanical Ventilation Day 14 · Patients not requiring mechanical ventilation	8 Participants	—
Mechanical Ventilation Day 14 · Patients deceased	11 Participants	—
Mechanical Ventilation Day 14 · Patients discharged	21 Participants	—
Mechanical Ventilation Day 21 · Patients requiring mechanical ventilation	5 Participants	—
Mechanical Ventilation Day 21 · Patients discharged	23 Participants	—
Mechanical Ventilation Day 28 · Patients requiring mechanical ventilation	2 Participants	—
Mechanical Ventilation Day 28 · Patients not requiring mechanical ventilation	3 Participants	—
Mechanical Ventilation Day 28 · Patients deceased	14 Participants	—
Mechanical Ventilation Day 28 · Patients discharged	26 Participants	—

SECONDARY outcome

Timeframe: Day 0 (date of CCP transfusion) to Day 28

Population: Patients that were hospitalized with COVID-19 and received CCP through the study

Number of participants who required a change in the mechanical ventilation status

Outcome measures

Outcome measures
Measure	Patients Hospitalized With COVID-19 n=45 Participants 45 patients were hospitalized with COVID-19 and received CCP through the study.	Patients Recovered From COVID-19 patients who donated CCP
Change in Mechanical Ventilation Status	6 Participants	—

SECONDARY outcome

Timeframe: From Day of Transfusion (Day 0) to Day 28 post-transfusion for patients who received CCP. Patients who donated CCP were not followed for a defined time period after CCP donation.

All-cause Mortality

Outcome measures

Outcome measures
Measure	Patients Hospitalized With COVID-19 n=45 Participants 45 patients were hospitalized with COVID-19 and received CCP through the study.	Patients Recovered From COVID-19 n=61 Participants patients who donated CCP
Mortality	14 Participants	0 Participants

Adverse Events

Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion

Serious events: 21 serious events

Other events: 0 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion n=45 participants at risk Patients hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome and meet eligibility criteria Convalescent plasma transfusion: Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome. Adverse Events only monitored/assessed in Convalescent Plasma Recipients.
Respiratory, thoracic and mediastinal disorders Death	31.1% 14/45 • Number of events 14 • Patients were monitored for up to 67 days Only serious adverse events were recorded.
Blood and lymphatic system disorders transfusion reaction	6.7% 3/45 • Number of events 3 • Patients were monitored for up to 67 days Only serious adverse events were recorded.
Respiratory, thoracic and mediastinal disorders Intubation	8.9% 4/45 • Number of events 4 • Patients were monitored for up to 67 days Only serious adverse events were recorded.

Other adverse events

Adverse event data not reported

Additional Information

Anne Whitney Brown, MD

Inova Health Systems

Phone: 7037763067

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place