Covid-19
Conditions
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.
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.
Interventions
BIOLOGICALCOVID-19 Convalescent Plasma
Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Time to Clinical Improvement. | Up to Study Day 29 | Time to removal from mechanical ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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: 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| Duration of Hospitalization | To Study Day 29 | Duration (days) of first hospitalization. Time until death or discharge or Study Day 29 |
| Mortality | 28 days from Study Day 1 | 28 day mortality |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Serious Adverse Events (SAEs) Through Day 29 of Convalescent Plasma Administration. | Through Study Day 29. | subjects with Serious Adverse Events (SAEs) through Day 29. |
| Number of Subjects With at Least One Day of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 14 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 14 / 32 |
| other Total, other adverse events | 32 / 32 |
| serious Total, serious adverse events | 23 / 32 |
Outcome results
Primary
Participants With Serious Adverse Events.
Cumulative incidence of participants with at least one serious adverse events (SAEs) at Study Day 29.
Time frame: Up to Study Day 29
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Participants With Serious Adverse Events. | 22 Participants |
Primary
Time to Clinical Improvement.
Time to removal from mechanical ventilation.
Time frame: Up to Study Day 29
Population: excludes those without improvement (were still on mechanical ventilation or died before removal of invasive mechanical ventilation/ECMO)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Time to Clinical Improvement. | 11 Days |
Secondary
Changes in ALT Measurement Through Day 29 of Convalescent Plasma Administration.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Changes in ALT Measurement Through Day 29 of Convalescent Plasma Administration. | -3.00 U/L |
Secondary
Changes in AST Measurement Through Day 29 of Convalescent Plasma Administration.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Changes in AST Measurement Through Day 29 of Convalescent Plasma Administration. | -7.50 U/L |
Secondary
Changes in Creatinine Measurement Through Day 29 of Convalescent Plasma Administration.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Changes in Creatinine Measurement Through Day 29 of Convalescent Plasma Administration. | -0.39 mg/dL |
Secondary
Changes in Glucose Measurement Through Day 29 of Convalescent Plasma Administration.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Changes in Glucose Measurement Through Day 29 of Convalescent Plasma Administration. | -36.00 mg/dL |
Secondary
Changes in Hemoglobin Measurement Through Day 29 of Convalescent Plasma Administration.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Changes in Hemoglobin Measurement Through Day 29 of Convalescent Plasma Administration. | -0.65 g/dL |
Secondary
Changes in Platelets Measurement Through Day 29 of Convalescent Plasma Administration.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Changes in Platelets Measurement Through Day 29 of Convalescent Plasma Administration. | 24 10^3 platelets per uL |
Secondary
Changes in PT Measurement Through Day 29 of Convalescent Plasma Administration.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Changes in PT Measurement Through Day 29 of Convalescent Plasma Administration. | -0.050 seconds |
Secondary
Changes in Total Bilirubin Measurement Through Day 29 of Convalescent Plasma Administration.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Changes in Total Bilirubin Measurement Through Day 29 of Convalescent Plasma Administration. | 0.00 mg/dL |
Secondary
Changes in WBC With Differential Through Day 29 of Convalescent Plasma Administration.
Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \> baseline lab value.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Changes in WBC With Differential Through Day 29 of Convalescent Plasma Administration. | 1.25 THO/uL |
Secondary
Clinical Status Assessment, Using 8-point Ordinal Scale, of Convalescent Plasma Administration
Time to improvement by at least 2 category from Day 1 (time to reach WHO8 \<=5). WHO8 score: 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
Time frame: Up to Study Day 29
Population: excludes those without improvement (WHO8 score of 6,7,or 8)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Clinical Status Assessment, Using 8-point Ordinal Scale, of Convalescent Plasma Administration | 12.5 days |
Secondary
Clinical Status Assessment Using the National Early Warning Score (NEWS) of Convalescent Plasma Administration
Time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first. NEWS assessed daily while hospitalized until discharge or death and on Days 15 and 29. Higher NEWS is worse, range from 0 to 20.
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Clinical Status Assessment Using the National Early Warning Score (NEWS) of Convalescent Plasma Administration | 10 days |
Secondary
Duration of Hospitalization
Duration (days) of first hospitalization. Time until death or discharge or Study Day 29
Time frame: To Study Day 29
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Duration of Hospitalization | 20 days |
Secondary
Duration of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration.
Days of new mechanical ventilation or ECMO use up to Day 29.
Time frame: From enrollment to Day 29.
Population: Endpoint was not well defined as all subjects started on mechanical ventilation
Secondary
Duration of New Oxygen Use up to Day 29 of Convalescent Plasma Administration
Days of new oxygen use up to Day 29.
Time frame: From enrollment to Day 29.
Population: this endpoint was not measured due to redundancy
Secondary
Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration.
Days of non-invasive ventilation/high flow oxygen up to Day 29.
Time frame: Daily while in hospital to Study Day 29.
Population: this endpoint was not measured due to redundancy with other endpoints (#8)
Secondary
Incidence of New Mechanical Ventilation or ECMO Use of Convalescent Plasma Administration.
Incidence of new mechanical ventilation or ECMO use up to Day 29.
Time frame: From enrollment to Day 29.
Population: Endpoint was not well defined as all subjects started on mechanical ventilation
Secondary
Incidence of New Oxygenation Use up to Day 29 of Convalescent Plasma Administration
Incidence of new oxygenation use up to Day 29.
Time frame: From enrollment to Day 29.
Population: this endpoint was not measured due to redundancy
Secondary
Invasive Ventilation/ Extracorporeal Membrane Oxygenation(ECMO) Days
Days on Invasive Ventilator/ECMO defined as WHO8 ordinal score of 7 = Hospitalized, on invasive mechanical ventilation or ECMO
Time frame: Daily while in hospital to Study Day 29
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Invasive Ventilation/ Extracorporeal Membrane Oxygenation(ECMO) Days | 11.5 days |
Secondary
Mortality
28 day mortality
Time frame: 28 days from Study Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Mortality | 14 Participants |
Secondary
Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 of Convalescent Plasma Administration.
Days of non-invasive ventilation/high flow oxygen while in hospital up to Day 29, defined as having WHO8 ordinal score of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 of Convalescent Plasma Administration. | 0 days |
Secondary
Number of Subjects With at Least One Day of Non-invasive Ventilation/High Flow Oxygen up to Day 29 of Convalescent Plasma Administration.
Number of subjects with at least one day of non-invasive ventilation (WHO8 ordinal score of 6) while in hospital
Time frame: Daily while in hospital to Study Day 29.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | 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
Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29 of Convalescent Plasma Administration.
Number of subjects with at least one Grade 3 or Grade 4 clinical and/or laboratory adverse events through Day 29.
Time frame: Through Study Day 29
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | 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
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.
Time frame: Daily while hospitalized up to Study Day 29.
Population: All 32 enrolled subjects were evaluated for days of oxygenation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Oxygenation | 16 days |
Secondary
Serious Adverse Events (SAEs) Through Day 29 of Convalescent Plasma Administration.
subjects with Serious Adverse Events (SAEs) through Day 29.
Time frame: Through Study Day 29.
Population: .this endpoint is redundant with the primary endpoint