Coronavirus, COVID-19, SARS-CoV-2
Conditions
Keywords
COVID-19 drug treatment, convalescent plasma
Brief summary
The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.
Detailed description
After being informed about the study and potential risks, participants confirmed to meet all eligibility criteria who have provided informed consent will be randomized 1:1 to convalescent plasma versus placebo. Transfusion of convalescent plasma or placebo will be administered by clinical or research personnel while the patient is hospitalized on Study Day 1. On Study Days 1-7, participants will be monitored for adverse reactions to the transfusion. Research personnel will also assess patients at Day 14 and Day 28; these assessments will be completed by phone if the participant has been discharged from the hospital.
Interventions
BIOLOGICALPlacebo
Lactated Ringer's solution with multivitamins
BIOLOGICALpathogen reduced SARS-CoV-2 convalescent plasma
Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
Sponsors
Dolly Parton
National Center for Advancing Translational Sciences (NCATS)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Eligible participants will be randomized 1:1 to convalescent plasma versus lactated Ringer's solution with multivitamins. Randomization will be completed in permuted blocks and stratified by site, gender, and age. Participants, treating clinicians and outcomes assessors will all be blinded to study group assignment. Study personnel will not be blinded to the study group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to 18 years 2. Currently hospitalized or in an emergency department with anticipated hospitalization 3. Symptoms of acute respiratory infection, defined as one or more of the following: 1. Cough 2. Chills, or a fever (greater than 37.5° C or 99.5° F) 3. Shortness of breath, operationalized as a patient having any of the following: i. Subjective shortness of breath reported by a patient or surrogate. ii. Tachypnea with respiratory rate of greater than 22 breaths per minute iii. Hypoxemia, defined as SpO2 less than 92% on room air, new receipt of supplemental oxygen to maintain SpO2 greater than or equal to 92%, or increased supplemental oxygen to maintain SpO2 greater than or equal to 92% for a patient on chronic oxygen therapy 4. Laboratory-confirmed SARS-CoV-2 infection within the past 14 days
Exclusion criteria
1. Prisoner 2. Unable to randomize within 14 days after onset of acute respiratory infection symptoms 3. Patient, legal representative, or physician not committed to full support (Exception: a patient who will receive all supportive care except for attempts at resuscitation from cardiac arrest will not be excluded.) 4. Inability to be contacted on Day 29-36 for clinical outcome assessment 5. Receipt of any SARS-CoV-2 passive immunity therapy, such as convalescent plasma, monoclonal antibodies, or pooled immunoglobulin, in the past 30 days 6. Contraindications to transfusion or history of prior reactions to transfused blood products 7. Plan for hospital discharge within 24 hours of enrollment 8. Previous enrollment in this trial 9. Previous laboratory-confirmed SARS-CoV-2 infection before the current illness 10. Enrollment in another clinical trial evaluating monoclonal antibodies, convalescent plasma, or another passive immunity therapy 11. Prior receipt of SARS-CoV-2 vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | Study Day 15 | Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival Through 28 Days | Baseline to Day 28 (assessed on Study Day 29) | Number of participants survived through Day 28 |
| COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | Baseline to Study Day 3 | Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death |
| COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | Study Day 8 | Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death |
| COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | Study Day 29 | Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death |
| Oxygen-free Days Through Day 28 | Baseline to Day 28 | Number of days without use of oxygen |
| Ventilator-free Days Through Day 28 | Baseline to Day 28 | Number of days without use of a ventilator |
| Vasopressor-free Days Through Day 28 | Baseline to Day 28 | Number of days without use of vasopressors |
| ICU-free Days Through Day 28 | Baseline to Day 28 | Number of days outside of ICU |
| Hospital-free Days Through Day 28 | Baseline to Day 28 | Number of days outside of the hospital |
| All-location, All-cause 14-day Mortality | Baseline to Study Day 14 | All-location, all-cause 14-day mortality; mortality was assessed via EHR review, phone call, social media review |
| All-location, All-cause 28-day Mortality | Baseline to Study Day 28 | All-location, all-cause 28-day mortality |
Other
| Measure | Time frame | Description |
|---|---|---|
| Documented Venous Thromboembolic Disease (DVT or PE) | Baseline to Day 28 | Number of participants with documented venous thromboembolic disease (DVT or PE) |
| Documented Cardiovascular Event (Myocardial Infarction or Ischemic Stroke) | Baseline to Day 28 | Number of Participants with myocardial infarction or ischemic stroke |
| Transfusion Reaction | Baseline to Day 28 | Number of participants with transfusion reaction (fever/rash) |
| Transfusion Related Acute Lung Injury (TRALI) | Baseline to Day 28 | Number of participants with transfusion related acute lung injury (TRALI) |
| Transfusion Associated Circulatory Overload (TACO) | Baseline to Day 28 | Number of participants with transfusion associated circulatory overload (TACO) |
| Transfusion Related Infection | Baseline to Day 28 | Number of participants with transfusion related infection |
| Acute Kidney Injury | Baseline to Day 28 | Number of participants with Acute kidney injury |
| Renal Replacement Therapy | Baseline to Day 28 | Number of participants requiring renal replacement therapy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma Transfusion of convalescent plasma will be administered by clinical or research personnel while the participant is hospitalized on Study Day 0. Plasma will be administered at a rate of 500 mL/hour and will be administered within 12 hours of randomization.
pathogen reduced SARS-CoV-2 convalescent plasma: Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection. | 487 |
| Placebo Participants randomized to the control group will receive 250mL of Lactate Ringers containing multivitamins intravenously on Day 1 as a placebo.
Placebo: Lactated Ringer's solution with multivitamins | 473 |
| Total | 960 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 8 |
| Overall Study | Withdrawn (Participant/PI withdrew consent) | 8 | 6 |
Baseline characteristics
| Characteristic | Pathogen Reduced SARS-CoV-2 Convalescent Plasma | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 191 Participants | 172 Participants | 363 Participants |
| Age, Categorical Between 18 and 65 years | 296 Participants | 301 Participants | 597 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 72 Participants | 71 Participants | 143 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 406 Participants | 396 Participants | 802 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 6 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 11 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 104 Participants | 80 Participants | 184 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 11 Participants | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 81 Participants | 77 Participants | 158 Participants |
| Race (NIH/OMB) White | 272 Participants | 285 Participants | 557 Participants |
| Region of Enrollment United States | 487 participants | 473 participants | 960 participants |
| Sex: Female, Male Female | 206 Participants | 204 Participants | 410 Participants |
| Sex: Female, Male Male | 281 Participants | 269 Participants | 550 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 89 / 495 | 80 / 479 |
| other Total, other adverse events | 27 / 495 | 19 / 479 |
| serious Total, serious adverse events | 21 / 495 | 16 / 479 |
Outcome results
Primary
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
Time frame: Study Day 15
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | 3: hospitalized and not on supplemental oxygen | 16 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | 5: hospitalized and on nasal high flow oxygen therapy or non-invasive ventilation | 16 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | 2: not hospitalized but unable to resume normal pre-illness activities | 157 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | 6: hospitalized and on invasive mechanical ventilation or ECMO | 43 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | 4: hospitalized and on standard flow oxygen | 42 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | 7: death | 63 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | 1: not hospitalized with resumption of normal pre-illness activities | 150 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | 7: death | 48 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | 1: not hospitalized with resumption of normal pre-illness activities | 144 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | 2: not hospitalized but unable to resume normal pre-illness activities | 167 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | 3: hospitalized and not on supplemental oxygen | 11 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | 4: hospitalized and on standard flow oxygen | 39 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | 5: hospitalized and on nasal high flow oxygen therapy or non-invasive ventilation | 15 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale Score | 6: hospitalized and on invasive mechanical ventilation or ECMO | 49 Participants |
Secondary
All-location, All-cause 14-day Mortality
All-location, all-cause 14-day mortality; mortality was assessed via EHR review, phone call, social media review
Time frame: Baseline to Study Day 14
Population: The participant flow table, lists the 947 that are not lost to follow-up. This matches the N for day 14 and day 28 mortality. While the primary endpoint can be calculated from the not withdrawn population, the mortality endpoints come from the not lost-to-follow-up population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | All-location, All-cause 14-day Mortality | 63 Participants |
| Placebo | All-location, All-cause 14-day Mortality | 48 Participants |
Secondary
All-location, All-cause 28-day Mortality
All-location, all-cause 28-day mortality
Time frame: Baseline to Study Day 28
Population: The participant flow table, lists the 947 that are not lost to follow-up. This matches the N for day 14 and day 28 mortality. While the primary endpoint can be calculated from the not withdrawn population, the mortality endpoints come from the not lost-to-follow-up population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | All-location, All-cause 28-day Mortality | 89 Participants |
| Placebo | All-location, All-cause 28-day Mortality | 80 Participants |
Secondary
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
Time frame: Study Day 29
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | 4: hospitalized and on standard flow oxygen | 11 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | 5: hospitalized and on nasal high flow oxygen therapy or non-invasive ventilation | 5 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | 1: not hospitalized with resumption of normal pre-illness activities | 183 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | 6: hospitalized and on invasive mechanical ventilation or ECMO | 24 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | 3: hospitalized and not on supplemental oxygen | 7 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | 7: death | 89 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | 2: not hospitalized but unable to resume normal pre-illness activities | 168 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | 7: death | 80 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | 1: not hospitalized with resumption of normal pre-illness activities | 204 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | 2: not hospitalized but unable to resume normal pre-illness activities | 144 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | 3: hospitalized and not on supplemental oxygen | 7 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | 5: hospitalized and on nasal high flow oxygen therapy or non-invasive ventilation | 4 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | 6: hospitalized and on invasive mechanical ventilation or ECMO | 20 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 29 | 4: hospitalized and on standard flow oxygen | 14 Participants |
Secondary
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
Time frame: Baseline to Study Day 3
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | 4: hospitalized and on standard flow oxygen | 201 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | 7: death | 10 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | 5: hospitalized and on nasal high flow oxygen therapy or non-invasive ventilation | 110 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | 2: not hospitalized but unable to resume normal pre-illness activities | 49 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | 6: hospitalized and on invasive mechanical ventilation or ECMO | 74 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | 1: not hospitalized with resumption of normal pre-illness activities | 1 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | 3: hospitalized and not on supplemental oxygen | 42 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | 7: death | 4 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | 1: not hospitalized with resumption of normal pre-illness activities | 6 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | 2: not hospitalized but unable to resume normal pre-illness activities | 54 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | 4: hospitalized and on standard flow oxygen | 184 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | 5: hospitalized and on nasal high flow oxygen therapy or non-invasive ventilation | 113 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | 6: hospitalized and on invasive mechanical ventilation or ECMO | 63 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 3 | 3: hospitalized and not on supplemental oxygen | 49 Participants |
Secondary
COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hospitalized, on ECMO, invasive mechanical ventilation, or both. 7. Death
Time frame: Study Day 8
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | 3: hospitalized and not on supplemental oxygen | 31 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | 5: hospitalized and on nasal high flow oxygen therapy or non-invasive ventilation | 58 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | 2: not hospitalized but unable to resume normal pre-illness activities | 130 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | 6: hospitalized and on invasive mechanical ventilation or ECMO | 64 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | 4: hospitalized and on standard flow oxygen | 77 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | 7: death | 32 Participants |
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | 1: not hospitalized with resumption of normal pre-illness activities | 95 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | 7: death | 22 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | 1: not hospitalized with resumption of normal pre-illness activities | 110 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | 2: not hospitalized but unable to resume normal pre-illness activities | 125 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | 3: hospitalized and not on supplemental oxygen | 16 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | 4: hospitalized and on standard flow oxygen | 78 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | 5: hospitalized and on nasal high flow oxygen therapy or non-invasive ventilation | 60 Participants |
| Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale on Study Day 8 | 6: hospitalized and on invasive mechanical ventilation or ECMO | 62 Participants |
Secondary
Hospital-free Days Through Day 28
Number of days outside of the hospital
Time frame: Baseline to Day 28
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | Hospital-free Days Through Day 28 | 20 Day |
| Placebo | Hospital-free Days Through Day 28 | 21 Day |
Secondary
ICU-free Days Through Day 28
Number of days outside of ICU
Time frame: Baseline to Day 28
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | ICU-free Days Through Day 28 | 28 Day |
| Placebo | ICU-free Days Through Day 28 | 28 Day |
Secondary
Oxygen-free Days Through Day 28
Number of days without use of oxygen
Time frame: Baseline to Day 28
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | Oxygen-free Days Through Day 28 | 21 Day |
| Placebo | Oxygen-free Days Through Day 28 | 21 Day |
Secondary
Survival Through 28 Days
Number of participants survived through Day 28
Time frame: Baseline to Day 28 (assessed on Study Day 29)
Population: The participant flow table, lists the 947 that are not lost to follow-up. Analysis includes 482 in the Convalescent Plasma arm and 465 in the Placebo arm. This matches the N for day 14 and day 28 mortality. While the primary endpoint can be calculated from the not withdrawn population, the mortality endpoints come from the not lost-to-follow-up population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | Survival Through 28 Days | 393 Participants |
| Placebo | Survival Through 28 Days | 385 Participants |
Secondary
Vasopressor-free Days Through Day 28
Number of days without use of vasopressors
Time frame: Baseline to Day 28
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | Vasopressor-free Days Through Day 28 | 28 Day |
| Placebo | Vasopressor-free Days Through Day 28 | 28 Day |
Secondary
Ventilator-free Days Through Day 28
Number of days without use of a ventilator
Time frame: Baseline to Day 28
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | Ventilator-free Days Through Day 28 | 28 Day |
| Placebo | Ventilator-free Days Through Day 28 | 28 Day |
Other Pre-specified
Acute Kidney Injury
Number of participants with Acute kidney injury
Time frame: Baseline to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | Acute Kidney Injury | 2 Participants |
| Placebo | Acute Kidney Injury | 0 Participants |
Other Pre-specified
Documented Cardiovascular Event (Myocardial Infarction or Ischemic Stroke)
Number of Participants with myocardial infarction or ischemic stroke
Time frame: Baseline to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | Documented Cardiovascular Event (Myocardial Infarction or Ischemic Stroke) | 22 Participants |
| Placebo | Documented Cardiovascular Event (Myocardial Infarction or Ischemic Stroke) | 18 Participants |
Other Pre-specified
Documented Venous Thromboembolic Disease (DVT or PE)
Number of participants with documented venous thromboembolic disease (DVT or PE)
Time frame: Baseline to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | Documented Venous Thromboembolic Disease (DVT or PE) | 101 Participants |
| Placebo | Documented Venous Thromboembolic Disease (DVT or PE) | 109 Participants |
Other Pre-specified
Renal Replacement Therapy
Number of participants requiring renal replacement therapy
Time frame: Baseline to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | Renal Replacement Therapy | 20 Participants |
| Placebo | Renal Replacement Therapy | 15 Participants |
Other Pre-specified
Transfusion Associated Circulatory Overload (TACO)
Number of participants with transfusion associated circulatory overload (TACO)
Time frame: Baseline to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | Transfusion Associated Circulatory Overload (TACO) | 1 Participants |
| Placebo | Transfusion Associated Circulatory Overload (TACO) | 0 Participants |
Other Pre-specified
Transfusion Reaction
Number of participants with transfusion reaction (fever/rash)
Time frame: Baseline to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | Transfusion Reaction | 6 Participants |
| Placebo | Transfusion Reaction | 0 Participants |
Other Pre-specified
Transfusion Related Acute Lung Injury (TRALI)
Number of participants with transfusion related acute lung injury (TRALI)
Time frame: Baseline to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | Transfusion Related Acute Lung Injury (TRALI) | 0 Participants |
| Placebo | Transfusion Related Acute Lung Injury (TRALI) | 0 Participants |
Other Pre-specified
Transfusion Related Infection
Number of participants with transfusion related infection
Time frame: Baseline to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pathogen Reduced SARS-CoV-2 Convalescent Plasma | Transfusion Related Infection | 0 Participants |
| Placebo | Transfusion Related Infection | 0 Participants |