COVID-19
Conditions
Keywords
Convalescent plasma
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 improves patients' health as compared to not using it in patients with pneumonia caused by SARS-CoV-2.
Detailed description
This open-label, randomized, controlled, phase 1 trial will assess the safety and efficacy of convalescent plasma in severely ill, hospitalized participants with pneumonia due to COVID-19. This study will enroll adults 18 years old and older, including pregnant women. A total of 80 eligible participants will be randomized to receive either 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 and standard of care (treatment arm) or standard of care alone (control arm). Participants in the treatment arm will receive 2 units of convalescent plasma on Study Day 1 in addition to standard of care. Participants will be assessed on study Day 1 (pre-dose), 30 minutes after each unit of plasma, on all Study Days while hospitalized, and Study Days 15, 22, 29, and 60. All participants will undergo a series of safety and efficacy, assessments. Blood samples will be collected on Days 1 (prior to plasma administration), 3, 8, 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
2 units of COVID-19 convalescent plasma compatible with their blood type
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized 1:1 to receive either convalescent plasma on Study Day 1 in addition to standard care or standard care alone.
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 in participating facility. 4. Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan). 5. Abnormal respiratory status that is judged worse than baseline by the investigator and as documented at any point within 24 hours prior to randomization, consistent with ordinal scale levels 5, 6 or 7, specifically defined as: * Room air saturation of oxygen (SaO2) \< 93%, OR * Requiring supplemental oxygen, OR * Tachypnea with respiratory rate ≥30 6. 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. 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 | Number of participants with at least one serious adverse events (SAEs) up to Study Day 29. |
| Clinical Severity Score | Up to Study Day 29 | Clinical Severity Score (CSC) measured by both survival time, time to recovery (defined by reaching levels 1-3 of the WHO modified 8-Point Ordinal Severity scale), and disease course while hospitalized and is calculated based on a procedure proposed by Shaw and Fay 2016 (https://doi.org/10.1002/sim.6950). CSC ranges from 1 to 57. Higher CSC is worse outcome. Clinical status assessment (WHO modified 8-Point Ordinal Severity scale) includes: 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation | Daily while hospitalized and up to Study Day 29 | Days of supplemental oxygen while in hospital. defined as days with WHO8 ordinal score of 5, 6, or 7 |
| Incidence of New Oxygenation Use up to Day 29 | From enrollment to Day 29. | Incidence of new oxygenation use up to Day 29. |
| Duration of New Oxygen Use up to Day 29 | From enrollment to Day 29. | Duration (days) of new oxygen use up to Day 29. |
| Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 | Daily while in hospital to Study Day 29. | Days of non-invasive ventilation/high flow oxygen up to Day 29 Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices |
| Number of Participants With at Least One Day on Non-invasive Ventilation/High Flow Oxygen up to Day 29 | Daily while in hospital until Study Day 29 | number of participants with at least one day on non-invasive ventilation/high flow oxygen Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices |
| Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29 | Daily while in hospital to Study Day 29. | Days of non-invasive ventilation/high flow oxygen up to Day 29 |
| Ventilator/ECMO Days to Day 29 | Daily while in hospital to Study Day 29 | Days of mechanical ventilation or ECMO use (having a WHO8 ordinal score of 7 = Hospitalized, on invasive mechanical ventilation or ECMO) during the study in hospital until study day 29. |
| New Mechanical Ventilation or ECMO Use | From enrollment to Day 29. | number of subjects with new mechanical ventilation or ECMO use up to Day 29 since all subjects were not on mechanical ventilation or ECMO at baseline. |
| Duration of New Mechanical Ventilation or ECMO | Daily while in hospital to Study Day 29 | Days of new mechanical ventilation or ECMO use up to Day 29. |
| 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. |
| Clinical Status Assessment, Time to Recovery | Up to Study Day 29 | Time to recovery, defined by time needed to reach levels 1-3 using the WHO modified 8-Point Ordinal Severity scale assessed daily while hospitalized and on Day 15, 22, and 29: 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 |
| Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29 | Through Study Day 29 | Number of subjects with at least one Grade 3 or Grade 4 clinical and/or laboratory adverse events (AEs) through Day 29. |
| Changes in WBC With Differential Through Day 29 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 Laboratory Through Day 29 | 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. |
| Number of Subjects With SAEs Through Day 29 | Through Study Day 29 | Number of subjects with SAEs through Day 29. |
| National Early Warning Score (NEWS) Clinical Status Assessment | Up to Study Day 29 | Time to discharge or to a National Early Warning Score (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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| COVID-19 Convalescent Plasma COVID-19 Convalescent plasma on Study Day 1 in addition to standard care
COVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type | 40 |
| Standard of Care Standard care alone | 39 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 11 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | COVID-19 Convalescent Plasma | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 18 Participants | 39 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 21 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 37 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 21 Participants | 42 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 | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 14 Participants | 16 Participants | 30 Participants |
| Region of Enrollment United States | 40 participants | 39 participants | 80 participants |
| Sex: Female, Male Female | 19 Participants | 24 Participants | 43 Participants |
| Sex: Female, Male Male | 21 Participants | 15 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 40 | 11 / 39 |
| other Total, other adverse events | 15 / 40 | 20 / 39 |
| serious Total, serious adverse events | 13 / 40 | 19 / 39 |
Outcome results
Primary
Clinical Severity Score
Clinical Severity Score (CSC) measured by both survival time, time to recovery (defined by reaching levels 1-3 of the WHO modified 8-Point Ordinal Severity scale), and disease course while hospitalized and is calculated based on a procedure proposed by Shaw and Fay 2016 (https://doi.org/10.1002/sim.6950). CSC ranges from 1 to 57. Higher CSC is worse outcome. Clinical status assessment (WHO modified 8-Point Ordinal Severity scale) includes: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| COVID-19 Convalescent Plasma | Clinical Severity Score | 7 scored on a scale (CSC) |
| Standard of Care | Clinical Severity Score | 10 scored on a scale (CSC) |
Primary
Participants With Serious Adverse Events.
Number of participants with at least one serious adverse events (SAEs) up to Study Day 29.
Time frame: Up to Study Day 29
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COVID-19 Convalescent Plasma | Participants With Serious Adverse Events. | 12 Participants |
| Standard of Care | Participants With Serious Adverse Events. | 15 Participants |
Secondary
Changes in ALT Measurement 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.
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.~Standard of care arm has analyzed sample size of 38 because one subject did not have ALT lab collected
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| COVID-19 Convalescent Plasma | Changes in ALT Measurement Through Day 29 | 0.00 U/L |
| Standard of Care | Changes in ALT Measurement Through Day 29 | -1.00 U/L |
Secondary
Changes in AST Measurement 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.
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.~Standard of care arm has analyzed sample size of 38 because one subject did not have AST lab collected
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| COVID-19 Convalescent Plasma | Changes in AST Measurement Through Day 29 | -7.00 U/L |
| Standard of Care | Changes in AST Measurement Through Day 29 | -6.00 U/L |
Secondary
Changes in Creatinine Measurement 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.
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) |
|---|---|---|
| COVID-19 Convalescent Plasma | Changes in Creatinine Measurement Through Day 29 | 0.035 mg/dL |
| Standard of Care | Changes in Creatinine Measurement Through Day 29 | -0.050 mg/dL |
Secondary
Changes in Glucose Measurement 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.
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) |
|---|---|---|
| COVID-19 Convalescent Plasma | Changes in Glucose Measurement Through Day 29 | -14.00 mg/dL |
| Standard of Care | Changes in Glucose Measurement Through Day 29 | -20.00 mg/dL |
Secondary
Changes in Hemoglobin Measurement 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.
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) |
|---|---|---|
| COVID-19 Convalescent Plasma | Changes in Hemoglobin Measurement Through Day 29 | -0.35 g/dL |
| Standard of Care | Changes in Hemoglobin Measurement Through Day 29 | -0.30 g/dL |
Secondary
Changes in Platelets Measurement 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.
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) |
|---|---|---|
| COVID-19 Convalescent Plasma | Changes in Platelets Measurement Through Day 29 | 38 10^3 platelets per uL |
| Standard of Care | Changes in Platelets Measurement Through Day 29 | 59 10^3 platelets per uL |
Secondary
Changes in PT Measurement Laboratory 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.
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.~Plasma arm analyzed sample size is 38 because 2 subjects did not have PT test collected.~Standard of care arm analyzed sample size is 37 because 2 subjects did not have PT test collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| COVID-19 Convalescent Plasma | Changes in PT Measurement Laboratory Through Day 29 | 0.0 seconds |
| Standard of Care | Changes in PT Measurement Laboratory Through Day 29 | 0.0 seconds |
Secondary
Changes in Total Bilirubin Measurement 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.
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.~Standard of care arm has analyzed sample size of 38 because one subject did not have total bilirubin lab collected
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| COVID-19 Convalescent Plasma | Changes in Total Bilirubin Measurement Through Day 29 | 0.00 mg/dL |
| Standard of Care | Changes in Total Bilirubin Measurement Through Day 29 | 0.00 mg/dL |
Secondary
Changes in WBC With Differential 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.
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) |
|---|---|---|
| COVID-19 Convalescent Plasma | Changes in WBC With Differential Through Day 29 | 1.45 THO/uL |
| Standard of Care | Changes in WBC With Differential Through Day 29 | 2.50 THO/uL |
Secondary
Clinical Status Assessment, Time to Recovery
Time to recovery, defined by time needed to reach levels 1-3 using the WHO modified 8-Point Ordinal Severity scale assessed daily while hospitalized and on Day 15, 22, and 29: 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: Population analyzed are only those who recovered. Remaining subjects either died or were still in hospital with WHO8 score \> 3 by Study Day 29.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| COVID-19 Convalescent Plasma | Clinical Status Assessment, Time to Recovery | 7 days |
| Standard of Care | Clinical Status Assessment, Time to Recovery | 7 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) |
|---|---|---|
| COVID-19 Convalescent Plasma | Duration of Hospitalization | 7 days |
| Standard of Care | Duration of Hospitalization | 9 days |
Secondary
Duration of New Mechanical Ventilation or ECMO
Days of new mechanical ventilation or ECMO use up to Day 29.
Time frame: Daily while in hospital to Study Day 29
Population: only includes subjects with new mechanical ventilation or ECMO
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| COVID-19 Convalescent Plasma | Duration of New Mechanical Ventilation or ECMO | 7 days |
| Standard of Care | Duration of New Mechanical Ventilation or ECMO | 12.5 days |
Secondary
Duration of New Oxygen Use up to Day 29
Duration (days) of new oxygen use up to Day 29.
Time frame: From enrollment to Day 29.
Population: This was not measured due to redundancy of endpoints
Secondary
Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29
Days of non-invasive ventilation/high flow oxygen up to Day 29
Time frame: Daily while in hospital to Study Day 29.
Population: not measured due to redundancy with other endpoints (#8)
Secondary
Incidence of New Oxygenation Use up to Day 29
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
Mortality
28 day mortality.
Time frame: 28 days from Study Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COVID-19 Convalescent Plasma | Mortality | 2 Participants |
| Standard of Care | Mortality | 10 Participants |
Secondary
National Early Warning Score (NEWS) Clinical Status Assessment
Time to discharge or to a National Early Warning Score (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: subjects who never reach National Early Warning Score (NEWS) of ≤ 2 or discharged by Study Day 29 have outcome measure of Infinity
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| COVID-19 Convalescent Plasma | National Early Warning Score (NEWS) Clinical Status Assessment | 3 days |
| Standard of Care | National Early Warning Score (NEWS) Clinical Status Assessment | 4 days |
Secondary
New Mechanical Ventilation or ECMO Use
number of subjects with new mechanical ventilation or ECMO use up to Day 29 since all subjects were not on mechanical ventilation or ECMO at baseline.
Time frame: From enrollment to Day 29.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COVID-19 Convalescent Plasma | New Mechanical Ventilation or ECMO Use | 5 Participants |
| Standard of Care | New Mechanical Ventilation or ECMO Use | 10 Participants |
Secondary
Non-invasive Ventilation/High Flow Oxygen Days up to Day 29
Days of non-invasive ventilation/high flow oxygen up to Day 29 Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices
Time frame: Daily while in hospital to Study Day 29.
Population: All subjects were evaluated. Subjects who never had a day with WHO8 ordinal score of 6 have outcome measurement of 0 days.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| COVID-19 Convalescent Plasma | Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 | 2 days |
| Standard of Care | Non-invasive Ventilation/High Flow Oxygen Days up to Day 29 | 3 days |
Secondary
Number of Participants With at Least One Day on Non-invasive Ventilation/High Flow Oxygen up to Day 29
number of participants with at least one day on non-invasive ventilation/high flow oxygen Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices
Time frame: Daily while in hospital until Study Day 29
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COVID-19 Convalescent Plasma | Number of Participants With at Least One Day on Non-invasive Ventilation/High Flow Oxygen up to Day 29 | 24 Participants |
| Standard of Care | Number of Participants With at Least One Day on Non-invasive Ventilation/High Flow Oxygen up to Day 29 | 23 Participants |
Secondary
Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29
Number of subjects with at least one Grade 3 or Grade 4 clinical and/or laboratory adverse events (AEs) through Day 29.
Time frame: Through Study Day 29
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COVID-19 Convalescent Plasma | Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29 | 18 Participants |
| Standard of Care | Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29 | 22 Participants |
Secondary
Number of Subjects With SAEs Through Day 29
Number of subjects with SAEs through Day 29.
Time frame: Through Study Day 29
Population: this endpoint is redundant with the primary endpoint
Secondary
Oxygenation
Days of supplemental oxygen while in hospital. defined as days with WHO8 ordinal score of 5, 6, or 7
Time frame: Daily while hospitalized and up to Study Day 29
Population: All subjects were evaluated. Subjects who never had a day with WHO8 ordinal score of 5, 6, or 7 have outcome measurement of 0 days.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| COVID-19 Convalescent Plasma | Oxygenation | 7 days |
| Standard of Care | Oxygenation | 8 days |
Secondary
Ventilator/ECMO Days to Day 29
Days of mechanical ventilation or ECMO use (having a WHO8 ordinal score of 7 = Hospitalized, on invasive mechanical ventilation or ECMO) during the study in hospital until study day 29.
Time frame: Daily while in hospital to Study Day 29
Population: All subjects were evaluated. Subjects who never had a day with WHO8 ordinal score of 7 have outcome measurement of 0 days.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| COVID-19 Convalescent Plasma | Ventilator/ECMO Days to Day 29 | 0 days |
| Standard of Care | Ventilator/ECMO Days to Day 29 | 0 days |