Covid-19
Conditions
Brief summary
The investigators hypothesize that use of convalescent plasma donated from individuals recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals with active, severe COVID-19 infection.
Detailed description
The purpose of this research study is to see if convalescent plasma is safe and effective for the treatment of patients acutely ill with COVID-19. The researchers want to confirm the right dose levels of immunoglobulins/antibodies (immune proteins) and find out what therapeutic effects plasma donated by recovered individuals has on people severely sick with COVID-19.
Interventions
BIOLOGICALConvalescent plasma transfusion
Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.
Sponsors
Inova Health Care Services
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase 1 will be recruitment and enrollment of plasma donors. Phase 2 will be continued recruitment and enrollment of plasma donors, with the addition of recruitment and enrollment of plasma recipients.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase 1 Inclusion Criteria: Inclusion Criteria for Convalescent Plasma Donors: \- Outpatients 18 years old and older who have recovered from COVID-19: * Have proof of Original Positive SARS-CoV-2 NAT nasopharyngeal (NP) test result * Complete resolution of symptoms at least 14 days prior to donation * Negative SARS-CoV-2 NAT nasopharyngeal (NP) specimen at screening visit * Able to meet standard criteria for blood donation * Clinically stable based on provider assessment Phase 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change is Clinical Status | Time of plasma infusion (day 0) compared to day 7 | 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 |
| Transfusion Related Events Due to Administration of CCP | Within 6 hours of infusion | Number of participants with Transfusion Related Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Ventilation | Days 7, 14, 21, 28 | Number of participants that required mechanical ventilation that were not on mechanical ventilation at that time point. |
| Change is Clinical Status | Time of plasma infusion (day 0 prior to first infusion) to 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 |
| Mortality | 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 |
| Change in Mechanical Ventilation Status | Day 0 (date of CCP transfusion) to Day 28 | Number of participants who required a change in the mechanical ventilation status |
| Length of Hospital Stay | Total Index Hospitalization | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion 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. | 48 |
| Donor of COVID-19 Convalescent Plasma (CCP) Patients who recovered from COVID-19 infection and test negative for COVID-19 by nasopharyngeal swab. | 61 |
| Total | 109 |
Baseline characteristics
| Characteristic | Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion | Donor of COVID-19 Convalescent Plasma (CCP) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 16 Participants | 7 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 54 Participants | 85 Participants |
| Age, Continuous | 59 years | 48 years | 53 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 4 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 54 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 27 Participants | 3 Participants | 30 Participants |
| Race (NIH/OMB) White | 12 Participants | 53 Participants | 65 Participants |
| Region of Enrollment United States | 48 participants | 61 participants | 109 participants |
| Sex: Female, Male Female | 30 Participants | 35 Participants | 65 Participants |
| Sex: Female, Male Male | 18 Participants | 26 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 14 / 45 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 21 / 45 |
Outcome results
Primary
Change is Clinical Status
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Average Day 7 Ordinal Scale | 3.86 units on a scale |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Average Day 1 Ordinal Scale | 3.06 units on a scale |
Primary
Transfusion Related Events Due to Administration of CCP
Number of participants with Transfusion Related Adverse Events
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Hospitalized With COVID-19 | Transfusion Related Events Due to Administration of CCP | 3 Participants |
Secondary
Change in Mechanical Ventilation Status
Number of participants who required a change in the mechanical ventilation status
Time frame: Day 0 (date of CCP transfusion) to Day 28
Population: Patients that were hospitalized with COVID-19 and received CCP through the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Hospitalized With COVID-19 | Change in Mechanical Ventilation Status | 6 Participants |
Secondary
Change is Clinical Status
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
Time frame: 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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 0 | Ordinal Scale 2 out of 7 | 10 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 0 | Ordinal Scale 3 out of 7 | 22 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 0 | Ordinal Scale 4 out of 7 | 13 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 0 | Ordinal Scale 5 out of 7 | 0 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 0 | Ordinal Scale 6 out of 7 | 0 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 0 | Ordinal Scale 7 out of 7 | 0 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 0 | Ordinal Scale 1 out of 7 | 0 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 7 | Ordinal Scale 2 out of 7 | 11 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 7 | Ordinal Scale 3 out of 7 | 6 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 7 | Ordinal Scale 4 out of 7 | 10 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 7 | Ordinal Scale 5 out of 7 | 1 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 7 | Ordinal Scale 6 out of 7 | 0 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 7 | Ordinal Scale 7 out of 7 | 12 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 7 | Ordinal Scale 1 out of 7 | 5 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 14 | Ordinal Scale 2 out of 7 | 5 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 14 | Ordinal Scale 3 out of 7 | 3 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 14 | Ordinal Scale 4 out of 7 | 5 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 14 | Ordinal Scale 5 out of 7 | 0 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 14 | Ordinal Scale 6 out of 7 | 0 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 14 | Ordinal Scale 7 out of 7 | 21 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 14 | Ordinal Scale 1 out of 7 | 11 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 21 | Ordinal Scale 2 out of 7 | 5 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 21 | Ordinal Scale 3 out of 7 | 1 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 21 | Ordinal Scale 4 out of 7 | 3 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 21 | Ordinal Scale 5 out of 7 | 0 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 21 | Ordinal Scale 6 out of 7 | 0 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 21 | Ordinal Scale 7 out of 7 | 23 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 21 | Ordinal Scale 1 out of 7 | 13 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 28 | Ordinal Scale 2 out of 7 | 2 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 28 | Ordinal Scale 3 out of 7 | 2 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 28 | Ordinal Scale 4 out of 7 | 1 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 28 | Ordinal Scale 5 out of 7 | 0 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 28 | Ordinal Scale 6 out of 7 | 0 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 28 | Ordinal Scale 7 out of 7 | 26 Participants |
| Patients Hospitalized With COVID-19 | Change is Clinical Status | Ordinal Scale Day 28 | Ordinal Scale 1 out of 7 | 14 Participants |
Secondary
Length of Hospital Stay
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)
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Patients Hospitalized With COVID-19 | Length of Hospital Stay | 20 days |
Secondary
Mechanical Ventilation
Number of participants that required mechanical ventilation that were not on mechanical ventilation at that time point.
Time frame: Days 7, 14, 21, 28
Population: The count of participants below shows the total number of participants needing mechanical ventilation for that time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 21 | Patients requiring mechanical ventilation | 5 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 7 | Patients requiring mechanical ventilation | 11 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 21 | Patients not requiring mechanical ventilation | 4 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 7 | Patients not requiring mechanical ventilation | 17 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 7 | Patients deceased | 5 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 7 | Patients discharged | 12 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 14 | Patients requiring mechanical ventilation | 5 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 14 | Patients not requiring mechanical ventilation | 8 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 14 | Patients deceased | 11 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 14 | Patients discharged | 21 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 21 | Patients deceased | 13 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 21 | Patients discharged | 23 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 28 | Patients requiring mechanical ventilation | 2 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 28 | Patients not requiring mechanical ventilation | 3 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 28 | Patients deceased | 14 Participants |
| Patients Hospitalized With COVID-19 | Mechanical Ventilation | Day 28 | Patients discharged | 26 Participants |
Secondary
Mortality
All-cause Mortality
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Hospitalized With COVID-19 | Mortality | 14 Participants |
| Patients Recovered From COVID-19 | Mortality | 0 Participants |