| 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:
- Not hospitalized with resumption of normal activities.
- Not hospitalized, but unable to resume normal activities.
- Hospitalized, not on supplemental oxygen.
- Hospitalized, on supplemental oxygen.
- Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
- Hospitalized, on ECMO, invasive mechanical ventilation, or both.
- Death
| | Posted | | Count of Participants | | Participants | | Study Day 15 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| 1: not hospitalized with resumption of normal pre-illness activities | | | 2: not hospitalized but unable to resume normal pre-illness activities | |
|
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| 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 | 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 While the primary endpoint can be calculated from the "not withdrawn" population, the mortality endpoints come from the "not lost-to-follow-up" population. | Posted | | Count of Participants | | Participants | | Baseline to Study Day 14 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| Secondary | All-location, All-cause 28-day Mortality | All-location, all-cause 28-day mortality | 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. | Posted | | Count of Participants | | Participants | | Baseline to Study Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| Secondary | Survival Through 28 Days | Number of participants survived through Day 28 | 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. | Posted | | Count of Participants | | Participants | | Baseline to Day 28 (assessed on Study Day 29) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| 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:
- Not hospitalized with resumption of normal activities.
- Not hospitalized, but unable to resume normal activities.
- Hospitalized, not on supplemental oxygen.
- Hospitalized, on supplemental oxygen.
- Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
- Hospitalized, on ECMO, invasive mechanical ventilation, or both.
- Death
| | Posted | | Count of Participants | | Participants | | Baseline to Study Day 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
|
| 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:
- Not hospitalized with resumption of normal activities.
- Not hospitalized, but unable to resume normal activities.
- Hospitalized, not on supplemental oxygen.
- Hospitalized, on supplemental oxygen.
- Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
- Hospitalized, on ECMO, invasive mechanical ventilation, or both.
- Death
| | Posted | | Count of Participants | | Participants | | Study Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
|
| 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:
- Not hospitalized with resumption of normal activities.
- Not hospitalized, but unable to resume normal activities.
- Hospitalized, not on supplemental oxygen.
- Hospitalized, on supplemental oxygen.
- Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
- Hospitalized, on ECMO, invasive mechanical ventilation, or both.
- Death
| | Posted | | Count of Participants | | Participants | | Study Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
|
| Secondary | Oxygen-free Days Through Day 28 | Number of days without use of oxygen | | Posted | | Median | Inter-Quartile Range | Day | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| Secondary | Ventilator-free Days Through Day 28 | Number of days without use of a ventilator | | Posted | | Median | Inter-Quartile Range | Day | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| Secondary | Vasopressor-free Days Through Day 28 | Number of days without use of vasopressors | | Posted | | Mean | Inter-Quartile Range | Day | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| Secondary | ICU-free Days Through Day 28 | Number of days outside of ICU | | Posted | | Median | Inter-Quartile Range | Day | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| Secondary | Hospital-free Days Through Day 28 | Number of days outside of the hospital | | Posted | | Median | Inter-Quartile Range | Day | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| Other Pre-specified | Acute Kidney Injury | Number of participants with Acute kidney injury | | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| Other Pre-specified | Renal Replacement Therapy | Number of participants requiring renal replacement therapy | | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| Other Pre-specified | Documented Venous Thromboembolic Disease (DVT or PE) | Number of participants with documented venous thromboembolic disease (DVT or PE) | | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| Other Pre-specified | Documented Cardiovascular Event (Myocardial Infarction or Ischemic Stroke) | Number of Participants with myocardial infarction or ischemic stroke | | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| Other Pre-specified | Transfusion Reaction | Number of participants with transfusion reaction (fever/rash) | | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| Other Pre-specified | Transfusion Related Acute Lung Injury (TRALI) | Number of participants with transfusion related acute lung injury (TRALI) | | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| Other Pre-specified | Transfusion Associated Circulatory Overload (TACO) | Number of participants with transfusion associated circulatory overload (TACO) | | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |
| Other Pre-specified | Transfusion Related Infection | Number of participants with transfusion related infection | | Posted | | Count of Participants | | Participants | | Baseline to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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 |
| |