COVID-19
Conditions
Keywords
2019 novel coronavirus disease, COVID-19 pandemic, COVID-19 virus infection, COVID-19 virus disease, Respiratory failure, Pneumonia, viral / therapy, Blood Component Transfusion, Severity of Illness Index, Survival Analysis, Treatment Outcome, Prospective Study, Humans, Adults, Male, Female, convalescent plasma, SARS CoV-2, COVID-19 convalescent plasma
Brief summary
The purpose of this study is to determine if treatment with convalescent plasma improves the clinical outcomes of Veterans who are hospitalized and require supplemental oxygen due to COVID-19.
Detailed description
As of August 25, 2020, SARS-Coronavirus 2 (SARS-CoV-2; COVID-19) infections are approaching 6 million persons and 180,000 deaths in the US. Of the 20% of patients admitted to hospital, up to half progress to ICU admission, respiratory failure or death. Prominent among these progressors are older men, particularly those with underlying comorbidities (e.g., hypertension, diabetes, lung, heart, kidney or liver disease, obesity and immunocompromised), all common among Veterans. There are no drugs or other therapeutics approved by the FDA to prevent or treat COVID-19 infection. Convalescent plasma therapy is being used empirically, although only five of six small uncontrolled case series (total n=56) in SARS-CoV-23-8 and a recent study with non-randomized controls suggest improved selected clinical, virologic and laboratory outcomes; outcomes in another small randomized trial were equivocal. For other infections, such as influenza and Ebola virus, promising observational studies were not reliably confirmed by controlled trials. In multiple infections, use of convalescent plasma has been distinguished by its safety profile but not by the consistency of its benefit. The current double-blind, placebo-controlled randomized clinical trial (RCT) is designed to determine definitively whether this intervention is effective in a population at high risk of complications and death from SARS-CoV-2 infection. The investigators compare the effect of convalescent plasma vs. saline placebo with a robust study design, adequate sample size and statistical and logistical rigor to assure that the interventions the investigators make to treat serious disease are well-validated to support its use or to move on to test other potentially safe and effective treatments. This study is taking place at approximately 25 Veterans Affairs (VA) Medical Centers located across the US. A participant's involvement will last up to 33 days. The entire study, from the date the first person enters until the last participant is seen, is expected to last about 20 months. Data collected for this study will be analyzed and stored at the Palo Alto Cooperative Studies Program Coordinating Center (CSPCC). After the study is completed, the de-identified, archived data will continue to be stored at the Palo Alto CSPCC, accessible for use by researchers including those outside of the study with an approved Data Use Agreement. The biospecimens collected in the study for current and future research will be kept at the VA Biorepository in Palo Alto, California unless otherwise specified. The biospecimens will be accessible for future research with an approved Sample Use Agreement. The VA Central Institutional Review Board (CIRB) will oversee the biorepository for this study. All samples will be destroyed by standard practice within 20 years of study completion. Sample destruction will be validated according to the Standard Operating Procedures of the VA Biorepository.
Interventions
DRUGConvalescent Plasma
Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
OTHERMasked Saline Placebo
0.9% saline solution will be used as the Masked Saline Placebo
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The participants, site investigators, clinical prescribers, site coordinators, and most other individuals involved in this study will be blinded to the treatment assignment. Furthermore, the blind will not routinely be broken in order to select post-study, pharmacologic treatment for SARS-CoV-2 infection administered by clinical healthcare providers.
Intervention model description
There are two study treatment arms: convalescent plasma versus saline. Participants will be randomized in 1:1 ratio to these two arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Veterans must meet all of the following criteria to be eligible to participate: 1. Admitted to a participating VA clinical site with symptoms suggestive of SARS-CoV-2 infection. 2. Participant (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 3. Participant (or legally authorized representative) understands and agrees to comply with planned study procedures. 4. Veteran 18 years of age at time of screening. 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or antigen test, as documented by either of the following: (1)Reverse Transcription polymerase chain reaction (RT-PCR) or antigen positive (nasopharyngeal, oropharyngeal, saliva, lower respiratory) in sample collected 72 hours prior to screening; (2)RT-PCR or antigen positive in sample collected \> 72 hours but 168 hours (i.e. 7 days) prior to screening, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking \> 24 hours, etc.), AND progressive disease suggestive of ongoing SARS-CoV-2 infection. 6.Requiring oxygen by nasal cannula or by face-mask as a new treatment (or if previously on home oxygen, at a liter flow at least 2 Lpm greater than home prescription), but not on humidified heated high-flow nasal cannula (HHHFNC) at 15 Lpm. 7.Can be randomized within 72 hours of hospital admission. 8.Agrees not to participate in another therapeutic clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29 without approval from the investigator(s). Taking part in other research studies, including those unrelated to SARS-CoV-2, without first discussing it with the investigators of this study may invalidate the results of this study, as well as that of the other study.
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study: 1. Respiratory failure requiring mechanical ventilation, non-invasive ventilation including continuous positive airway pressure (CPAP) (for an indication other than previously diagnosed sleep apnea and maintained on outpatient settings), or extra-corporeal membrane oxygenation or anticipated to require any of those treatments or to die within 24 hours. 2. Anticipated discharge from the hospital or transfer to another hospital that is not a study site within 72 hours. 3. History of previous transfusion reaction. 4. Previously documented serum immunoglobulin A (IgA) deficiency (\<7 mg/dL) 5. Documented to have received convalescent plasma in the last 60 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Developing Acute Hypoxemic Respiratory Failure or All-cause Death | Day 1 through Day 28 | Respiratory failure is defined as requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time (in Days) to Death or Respiratory Failure | Day 1 through Day 28 | Defined as the first day on which the subject died from any cause or had respiratory failure. Respiratory failure is defined by requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation. |
| Proportion of Patients Who Died From Any Cause, Had Respiratory Failure, or Required Humidified Heated High-flow Nasal Cannula (HHHFNC) at >= 15 Lpm | Day 1 through Day 28 | Defined as the proportion of subjects who died from any cause, had respiratory failure, or who required humidified heater high-flow cannula (HHHFNC) at \>= 15 Lpm. Respiratory failure is defined by requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation. |
| Time (in Days) to Death, Respiratory Failure, or HHHFNC at >= 15 Lpm | Day 1 through Day 28 | Time to death or respiratory failure is defined as the first day on which the subject died from any cause, had respiratory failure (defined above), or who required HHHFNC at \>= 15 Lpm. |
| Number of Participants With 28-day All-cause Mortality | Day 1 through Day 28 | Death for Any Reason |
| Time to an Improvement of at Least One Category Using an Ordinal Scale | Up through 28 days. | Number of Days until the Modified WHO Clinical Status Improved by at Least One Category Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO); 8) Death. The higher the score, the worse the outcome. |
| Time to an Improvement of at Least Two Categories Using an Ordinal Scale | Up through 28 days. | Number of Days until the Modified WHO Clinical Status Improved by at Least Two Categories Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome. |
| Time (in Days) to Recovery | Day 1 through Day 28 | Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the Modified World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement : 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy. |
| Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | From Baseline to Days 2, 4, 7, 11, 14, 21, and 28. | Change in the Modified WHO Clinical Status Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome. |
| Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | From Baseline to Days 2, 4, 7, 11, 14, 21, and 28. | Categorical Change in the Modified WHO 8-point Ordinal Scale for Clinical Improvement Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome. |
| Time to Discharge or to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for at Least 22 Hours, Whichever Occurs First | Up through 28 days. | Number of Days until Initial Hospitalization Discharge or (NEWS2 \<= 2 Maintained for at Least 22 Hours) The National Early Warning Score 2 (NEWS2) score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters and ranges from 0 to 20. The NEWS2 is being used as an efficacy measure. Higher scores mean a worse outcome. |
| Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29 | From Day 1 (baseline) to Days 2, 4, 7, 11, 15, and 29 | Change in NEWS2 The National Early Warning Score 2 (NEWS2) has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters and ranges from 0 to 20. The NEWS2 is being used as an efficacy measure. Higher scores mean a worse outcome. |
| Duration of Hospitalization | Day 1 through Day 28 | Number of Days Hospitalized During Initial Hospitalization |
| Incidence of Discontinuation or Temporary Suspension of Study Product Administrations (for Any Reason) | Day 1 through Day 3 | Number of participants for whom study product administration was discontinued or temporarily suspended for any reason |
| Participant's Clinical Status by Ordinal Scale | Days 2, 4, 7, 11, 14, 21, and 28 | Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Convalescent Plasma The study intervention consists of intravenous administration of 200-500 mL of convalescent plasma administered in two equally divided doses, less than 12 hours apart.
Convalescent Plasma: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection. | 35 |
| Masked Saline Placebo The study intervention consists of intravenous administration of 200-500 mL of 0.9% saline administered in two equally divided doses, less than 12 hours apart.
Masked Saline Placebo: 0.9% saline solution will be used as the Masked Saline Placebo | 40 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 4 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Masked Saline Placebo | Convalescent Plasma | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 19 Participants | 41 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 16 Participants | 34 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 11.5 | 65.6 years STANDARD_DEVIATION 14.5 | 66.4 years STANDARD_DEVIATION 13 |
| Alanine Transaminase (ALT/SGPT) | 31 U/L | 30 U/L | 30 U/L |
| Aspartate Transaminase (AST/SGOT) | 35 U/L | 29 U/L | 34 U/L |
| Clinical Status Ambulatory, limitation of activity and/or home oxygen | 0 Participants | 0 Participants | 0 Participants |
| Clinical Status Ambulatory, no limitation of activity | 0 Participants | 0 Participants | 0 Participants |
| Clinical Status Death | 0 Participants | 0 Participants | 0 Participants |
| Clinical Status Hospitalized Mild Disease, no oxygen therapy | 0 Participants | 0 Participants | 0 Participants |
| Clinical Status Hospitalized Mild Disease, oxygen by mask or nasal prong | 40 Participants | 34 Participants | 74 Participants |
| Clinical Status Hospitalized Severe Disease, humidified high-flow oxygen | 0 Participants | 1 Participants | 1 Participants |
| Clinical Status Hospitalized Severe Disease, intubation and mechanical ventilation | 0 Participants | 0 Participants | 0 Participants |
| Clinical Status Hospitalized Severe Disease, non-invasive ventilation | 0 Participants | 0 Participants | 0 Participants |
| Clinical Status Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 0 Participants | 0 Participants | 0 Participants |
| Creatinine | 1 mg/dL | 0.9 mg/dL | 1 mg/dL |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 8 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 26 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Glucose | 160 mg/dL | 144 mg/dL | 154 mg/dL |
| Hemoglobin | 13.5 g/dL | 13.5 g/dL | 13.5 g/dL |
| International Normalized Ratio (INR) | 1.2 unitless | 1.11 unitless | 1.15 unitless |
| Neutrophil Count | 5.7 K cells/mcL | 6.3 K cells/mcL | 6 K cells/mcL |
| NEWS2 | 4 units on a scale | 3 units on a scale | 4 units on a scale |
| Platelets | 207 K cells/mcL | 246 K cells/mcL | 229 K cells/mcL |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 11 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 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 | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 22 Participants | 21 Participants | 43 Participants |
| Region of Enrollment United States | 40 Participants | 35 Participants | 75 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 38 Participants | 34 Participants | 72 Participants |
| Total Lymphocyte Count | 0.8 K cells/mcL | 0.9 K cells/mcL | 0.9 K cells/mcL |
| White Blood Cell (WBC) Count | 6.8 K cells/mcL | 7.9 K cells/mcL | 7.4 K cells/mcL |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 35 | 4 / 40 |
| other Total, other adverse events | 5 / 35 | 9 / 40 |
| serious Total, serious adverse events | 8 / 35 | 5 / 40 |
Outcome results
Primary
Proportion of Participants Developing Acute Hypoxemic Respiratory Failure or All-cause Death
Respiratory failure is defined as requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.
Time frame: Day 1 through Day 28
Population: The primary outcome cannot be determined for 5 participants (4 in Convalescent Plasma, and 1 in Masked Saline Placebo) who terminated early from the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Convalescent Plasma | Proportion of Participants Developing Acute Hypoxemic Respiratory Failure or All-cause Death | 3 Participants |
| Masked Saline Placebo | Proportion of Participants Developing Acute Hypoxemic Respiratory Failure or All-cause Death | 4 Participants |
p-value: 195% CI: [-0.15, 0.14]Fisher Exact
Secondary
Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Categorical Change in the Modified WHO 8-point Ordinal Scale for Clinical Improvement Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.
Time frame: From Baseline to Days 2, 4, 7, 11, 14, 21, and 28.
Population: This secondary outcome cannot be determined for 3 participants (3 in Convalescent Plasma, and 0 in Masked Saline Placebo) who terminated on the day of randomization.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 4 Point Improvement | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 1 Point Worsening | 3 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | No Change | 19 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 2 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | No Change | 29 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 3 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 2 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 4 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 1 Point Worsening | 2 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 4 Point Improvement | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 3 Point Worsening | 1 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 3 Point Improvement | 6 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 1 Point Improvement | 2 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 2 Point Improvement | 18 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 4 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 1 Point Improvement | 2 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 2 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | No Change | 2 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 4 Point Improvement | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 1 Point Worsening | 1 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 3 Point Improvement | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 2 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 3 Point Improvement | 6 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 3 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 3 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 4 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 1 Point Worsening | 2 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 4 Point Improvement | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | No Change | 8 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 3 Point Improvement | 7 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 4 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 2 Point Improvement | 16 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 1 Point Worsening | 3 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 1 Point Improvement | 3 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 2 Point Improvement | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | No Change | 2 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 2 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 1 Point Worsening | 1 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 4 Point Improvement | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 2 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 3 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 3 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 2 Point Improvement | 11 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 4 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 4 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 4 Point Improvement | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 4 Point Improvement | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 3 Point Improvement | 6 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 3 Point Improvement | 2 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 2 Point Improvement | 20 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 3 Point Improvement | 5 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 1 Point Improvement | 1 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 2 Point Improvement | 2 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | No Change | 2 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 2 Point Improvement | 17 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 1 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 1 Point Improvement | 1 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 2 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 1 Point Improvement | 3 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 3 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 1 Point Improvement | 6 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 4 Point Worsening | 0 Participants |
| Convalescent Plasma | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | No Change | 2 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 4 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 3 Point Improvement | 2 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | No Change | 23 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 1 Point Improvement | 3 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 4 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 4 Point Improvement | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 3 Point Improvement | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 2 Point Improvement | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 1 Point Improvement | 1 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 1 Point Worsening | 3 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 2 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 3 Point Worsening | 1 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 4 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 4 Point Improvement | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 2 Point Improvement | 6 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 1 Point Improvement | 1 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 1 Point Worsening | 6 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 2 Point Worsening | 1 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 3 Point Worsening | 1 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 4 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 4 Point Improvement | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 3 Point Improvement | 4 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 2 Point Improvement | 17 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | No Change | 10 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 1 Point Worsening | 3 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 2 Point Worsening | 1 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | 3 Point Worsening | 1 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 4 Point Improvement | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 3 Point Improvement | 5 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 2 Point Improvement | 23 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 1 Point Improvement | 1 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | No Change | 6 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 1 Point Worsening | 1 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 2 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 3 Point Worsening | 1 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | 4 Point Worsening | 1 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 4 Point Improvement | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 3 Point Improvement | 5 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 2 Point Improvement | 23 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 1 Point Improvement | 2 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | No Change | 5 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 1 Point Worsening | 1 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 2 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 3 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | 4 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 4 Point Improvement | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 3 Point Improvement | 9 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 2 Point Improvement | 24 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 1 Point Improvement | 1 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | No Change | 2 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 1 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 2 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 3 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | 4 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 4 Point Improvement | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 3 Point Improvement | 11 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 2 Point Improvement | 23 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 1 Point Improvement | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | No Change | 1 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 1 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 2 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | 3 Point Worsening | 0 Participants |
| Masked Saline Placebo | Categorical Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | No Change | 35 Participants |
Secondary
Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29
Change in NEWS2 The National Early Warning Score 2 (NEWS2) has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters and ranges from 0 to 20. The NEWS2 is being used as an efficacy measure. Higher scores mean a worse outcome.
Time frame: From Day 1 (baseline) to Days 2, 4, 7, 11, 15, and 29
Population: This secondary outcome cannot be determined for 3 participants (3 in Convalescent Plasma, and 0 in Masked Saline Placebo) who terminated on the day of randomization.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Convalescent Plasma | Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29 | Day 1 to Day 2 | 0 score on a scale |
| Convalescent Plasma | Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29 | Day 1 to Day 4 | -0.5 score on a scale |
| Convalescent Plasma | Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29 | Day 1 to Day 7 | -1 score on a scale |
| Convalescent Plasma | Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29 | Day 1 to Day 11 | -2 score on a scale |
| Convalescent Plasma | Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29 | Day 1 to Day 15 | -2 score on a scale |
| Convalescent Plasma | Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29 | Day 1 to Day 29 | -2 score on a scale |
| Masked Saline Placebo | Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29 | Day 1 to Day 15 | -1.5 score on a scale |
| Masked Saline Placebo | Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29 | Day 1 to Day 2 | 0 score on a scale |
| Masked Saline Placebo | Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29 | Day 1 to Day 11 | -1 score on a scale |
| Masked Saline Placebo | Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29 | Day 1 to Day 4 | -1 score on a scale |
| Masked Saline Placebo | Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29 | Day 1 to Day 29 | -2 score on a scale |
| Masked Saline Placebo | Change in National Early Warning Score 2 (NEWS2) From Day 1 (Baseline) to Days 2, 4, 7, 11, 15, and 29 | Day 1 to Day 7 | 0 score on a scale |
Secondary
Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28
Change in the Modified WHO Clinical Status Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.
Time frame: From Baseline to Days 2, 4, 7, 11, 14, 21, and 28.
Population: This secondary outcome cannot be determined for 3 participants (3 in Convalescent Plasma, and 0 in Masked Saline Placebo) who terminated on the day of randomization.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Convalescent Plasma | Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | -2 units on a scale |
| Convalescent Plasma | Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 0 units on a scale |
| Convalescent Plasma | Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | -2 units on a scale |
| Convalescent Plasma | Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 0 units on a scale |
| Convalescent Plasma | Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | -2 units on a scale |
| Convalescent Plasma | Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | -2 units on a scale |
| Convalescent Plasma | Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | -2 units on a scale |
| Masked Saline Placebo | Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 28 | -2 units on a scale |
| Masked Saline Placebo | Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 4 | 0 units on a scale |
| Masked Saline Placebo | Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 7 | -2 units on a scale |
| Masked Saline Placebo | Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 11 | -2 units on a scale |
| Masked Saline Placebo | Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 14 | -2 units on a scale |
| Masked Saline Placebo | Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 21 | -2 units on a scale |
| Masked Saline Placebo | Change in the Ordinal Scale From Baseline to Days 2, 4, 7, 11, 14, 21, and 28 | Baseline to Day 2 | 0 units on a scale |
Secondary
Duration of Hospitalization
Number of Days Hospitalized During Initial Hospitalization
Time frame: Day 1 through Day 28
Population: This secondary outcome cannot be determined for 3 participants (3 in Convalescent Plasma, and 0 in Masked Saline Placebo) who terminated early on the day of randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Convalescent Plasma | Duration of Hospitalization | 5.5 days |
| Masked Saline Placebo | Duration of Hospitalization | 6 days |
p-value: 0.864295% CI: [-2.3, 2.3]Wilcoxon (Mann-Whitney)
Secondary
Incidence of Discontinuation or Temporary Suspension of Study Product Administrations (for Any Reason)
Number of participants for whom study product administration was discontinued or temporarily suspended for any reason
Time frame: Day 1 through Day 3
Population: 3 participants in the Convalescent Plasma group withdrew from the study prior to study product administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Convalescent Plasma | Incidence of Discontinuation or Temporary Suspension of Study Product Administrations (for Any Reason) | 0 Participants |
| Masked Saline Placebo | Incidence of Discontinuation or Temporary Suspension of Study Product Administrations (for Any Reason) | 0 Participants |
Secondary
Number of Participants With 28-day All-cause Mortality
Death for Any Reason
Time frame: Day 1 through Day 28
Population: This secondary outcome cannot be determined for 5 participants (4 in Convalescent Plasma, and 1 in Masked Saline Placebo) who terminated early from the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Convalescent Plasma | Number of Participants With 28-day All-cause Mortality | 2 Participants |
| Masked Saline Placebo | Number of Participants With 28-day All-cause Mortality | 4 Participants |
p-value: 0.686795% CI: [-0.17, 0.09]Fisher Exact
Secondary
Participant's Clinical Status by Ordinal Scale
Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.
Time frame: Days 2, 4, 7, 11, 14, 21, and 28
Population: This secondary outcome cannot be determined for 3 participants (3 in Convalescent Plasma, and 0 in Masked Saline Placebo) who terminated on the day of randomization.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 28 | Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 11 | Hospitalized Severe Disease, humidified high-flow oxygen | 2 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 4 | Hospitalized Severe Disease, intubation and mechanical ventilation | 1 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 11 | Hospitalized Severe Disease, non-invasive ventilation | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 2 | Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 11 | Hospitalized Severe Disease, intubation and mechanical ventilation | 1 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 4 | Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 1 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 11 | Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 2 | Hospitalized Mild Disease, oxygen by mask or nasal prong | 28 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 11 | Death | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 4 | Death | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 14 | Ambulatory, no limitation of activity | 6 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 7 | Ambulatory, no limitation of activity | 6 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 14 | Ambulatory, limitation of activity and/or home oxygen | 18 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 2 | Ambulatory, limitation of activity and/or home oxygen | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 14 | Hospitalized Mild Disease, no oxygen therapy | 2 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 7 | Ambulatory, limitation of activity and/or home oxygen | 11 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 14 | Hospitalized Mild Disease, oxygen by mask or nasal prong | 2 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 4 | Ambulatory, no limitation of activity | 2 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 14 | Hospitalized Severe Disease, humidified high-flow oxygen | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 7 | Hospitalized Mild Disease, no oxygen therapy | 2 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 14 | Hospitalized Severe Disease, non-invasive ventilation | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 2 | Hospitalized Severe Disease, humidified high-flow oxygen | 1 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 14 | Hospitalized Severe Disease, intubation and mechanical ventilation | 1 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 7 | Hospitalized Mild Disease, oxygen by mask or nasal prong | 8 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 14 | Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 4 | Ambulatory, limitation of activity and/or home oxygen | 2 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 14 | Death | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 7 | Hospitalized Severe Disease, humidified high-flow oxygen | 2 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 21 | Ambulatory, no limitation of activity | 7 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 2 | Ambulatory, no limitation of activity | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 21 | Ambulatory, limitation of activity and/or home oxygen | 16 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 7 | Hospitalized Severe Disease, non-invasive ventilation | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 21 | Hospitalized Mild Disease, no oxygen therapy | 3 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 4 | Hospitalized Mild Disease, no oxygen therapy | 6 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 21 | Hospitalized Mild Disease, oxygen by mask or nasal prong | 2 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 7 | Hospitalized Severe Disease, intubation and mechanical ventilation | 1 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 21 | Hospitalized Severe Disease, humidified high-flow oxygen | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 2 | Hospitalized Severe Disease, non-invasive ventilation | 2 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 21 | Hospitalized Severe Disease, non-invasive ventilation | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 7 | Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 21 | Hospitalized Severe Disease, intubation and mechanical ventilation | 1 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 4 | Hospitalized Mild Disease, oxygen by mask or nasal prong | 19 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 21 | Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 7 | Death | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 21 | Death | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 2 | Hospitalized Mild Disease, no oxygen therapy | 1 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 28 | Ambulatory, no limitation of activity | 6 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 11 | Ambulatory, no limitation of activity | 5 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 28 | Ambulatory, limitation of activity and/or home oxygen | 20 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 4 | Hospitalized Severe Disease, humidified high-flow oxygen | 1 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 28 | Hospitalized Mild Disease, no oxygen therapy | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 11 | Ambulatory, limitation of activity and/or home oxygen | 17 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 28 | Hospitalized Mild Disease, oxygen by mask or nasal prong | 3 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 2 | Hospitalized Severe Disease, intubation and mechanical ventilation | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 28 | Hospitalized Severe Disease, humidified high-flow oxygen | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 11 | Hospitalized Mild Disease, no oxygen therapy | 3 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 28 | Hospitalized Severe Disease, non-invasive ventilation | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 28 | Hospitalized Severe Disease, intubation and mechanical ventilation | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 4 | Hospitalized Severe Disease, non-invasive ventilation | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 11 | Hospitalized Mild Disease, oxygen by mask or nasal prong | 2 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 28 | Death | 0 Participants |
| Convalescent Plasma | Participant's Clinical Status by Ordinal Scale | Day 2 | Death | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 28 | Death | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 4 | Death | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 28 | Hospitalized Severe Disease, non-invasive ventilation | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 2 | Ambulatory, no limitation of activity | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 2 | Ambulatory, limitation of activity and/or home oxygen | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 2 | Hospitalized Mild Disease, no oxygen therapy | 1 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 2 | Hospitalized Mild Disease, oxygen by mask or nasal prong | 35 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 2 | Hospitalized Severe Disease, humidified high-flow oxygen | 3 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 2 | Hospitalized Severe Disease, non-invasive ventilation | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 2 | Hospitalized Severe Disease, intubation and mechanical ventilation | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 2 | Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 1 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 2 | Death | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 4 | Ambulatory, no limitation of activity | 2 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 4 | Ambulatory, limitation of activity and/or home oxygen | 6 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 4 | Hospitalized Mild Disease, no oxygen therapy | 1 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 4 | Hospitalized Mild Disease, oxygen by mask or nasal prong | 23 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 4 | Hospitalized Severe Disease, humidified high-flow oxygen | 6 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 4 | Hospitalized Severe Disease, non-invasive ventilation | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 4 | Hospitalized Severe Disease, intubation and mechanical ventilation | 1 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 4 | Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 1 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 7 | Ambulatory, no limitation of activity | 4 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 7 | Ambulatory, limitation of activity and/or home oxygen | 17 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 7 | Hospitalized Mild Disease, no oxygen therapy | 3 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 7 | Hospitalized Mild Disease, oxygen by mask or nasal prong | 10 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 7 | Hospitalized Severe Disease, humidified high-flow oxygen | 3 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 7 | Hospitalized Severe Disease, non-invasive ventilation | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 7 | Hospitalized Severe Disease, intubation and mechanical ventilation | 1 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 7 | Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 1 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 7 | Death | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 11 | Ambulatory, no limitation of activity | 5 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 11 | Ambulatory, limitation of activity and/or home oxygen | 23 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 11 | Hospitalized Mild Disease, no oxygen therapy | 1 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 11 | Hospitalized Mild Disease, oxygen by mask or nasal prong | 6 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 11 | Hospitalized Severe Disease, humidified high-flow oxygen | 1 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 11 | Hospitalized Severe Disease, non-invasive ventilation | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 11 | Hospitalized Severe Disease, intubation and mechanical ventilation | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 11 | Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 1 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 11 | Death | 1 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 14 | Ambulatory, no limitation of activity | 5 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 14 | Ambulatory, limitation of activity and/or home oxygen | 23 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 14 | Hospitalized Mild Disease, no oxygen therapy | 2 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 14 | Hospitalized Mild Disease, oxygen by mask or nasal prong | 5 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 14 | Hospitalized Severe Disease, humidified high-flow oxygen | 1 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 14 | Hospitalized Severe Disease, non-invasive ventilation | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 14 | Hospitalized Severe Disease, intubation and mechanical ventilation | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 14 | Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 14 | Death | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 21 | Ambulatory, no limitation of activity | 9 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 21 | Ambulatory, limitation of activity and/or home oxygen | 24 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 21 | Hospitalized Mild Disease, no oxygen therapy | 1 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 21 | Hospitalized Mild Disease, oxygen by mask or nasal prong | 2 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 21 | Hospitalized Severe Disease, humidified high-flow oxygen | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 21 | Hospitalized Severe Disease, non-invasive ventilation | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 21 | Hospitalized Severe Disease, intubation and mechanical ventilation | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 21 | Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 21 | Death | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 28 | Ambulatory, no limitation of activity | 11 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 28 | Ambulatory, limitation of activity and/or home oxygen | 23 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 28 | Hospitalized Mild Disease, no oxygen therapy | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 28 | Hospitalized Mild Disease, oxygen by mask or nasal prong | 1 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 28 | Hospitalized Severe Disease, humidified high-flow oxygen | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 28 | Hospitalized Severe Disease, intubation and mechanical ventilation | 0 Participants |
| Masked Saline Placebo | Participant's Clinical Status by Ordinal Scale | Day 28 | Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO | 0 Participants |
Secondary
Proportion of Patients Who Died From Any Cause, Had Respiratory Failure, or Required Humidified Heated High-flow Nasal Cannula (HHHFNC) at >= 15 Lpm
Defined as the proportion of subjects who died from any cause, had respiratory failure, or who required humidified heater high-flow cannula (HHHFNC) at \>= 15 Lpm. Respiratory failure is defined by requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.
Time frame: Day 1 through Day 28
Population: This secondary outcome cannot be determined for 5 participants (4 in Convalescent Plasma, and 1 in Masked Saline Placebo) who terminated early from the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Convalescent Plasma | Proportion of Patients Who Died From Any Cause, Had Respiratory Failure, or Required Humidified Heated High-flow Nasal Cannula (HHHFNC) at >= 15 Lpm | 4 Participants |
| Masked Saline Placebo | Proportion of Patients Who Died From Any Cause, Had Respiratory Failure, or Required Humidified Heated High-flow Nasal Cannula (HHHFNC) at >= 15 Lpm | 8 Participants |
p-value: 0.401495% CI: [-0.25, 0.1]Chi-squared
Secondary
Time (in Days) to Death or Respiratory Failure
Defined as the first day on which the subject died from any cause or had respiratory failure. Respiratory failure is defined by requiring mechanical ventilation, with or without endotracheal intubations, or extra-corporeal membrane oxygenation.
Time frame: Day 1 through Day 28
Population: All randomized participants are included in the analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Convalescent Plasma | Time (in Days) to Death or Respiratory Failure | NA days |
| Masked Saline Placebo | Time (in Days) to Death or Respiratory Failure | NA days |
p-value: 0.94395% CI: [0.21, 4.23]Log Rank
Secondary
Time (in Days) to Death, Respiratory Failure, or HHHFNC at >= 15 Lpm
Time to death or respiratory failure is defined as the first day on which the subject died from any cause, had respiratory failure (defined above), or who required HHHFNC at \>= 15 Lpm.
Time frame: Day 1 through Day 28
Population: All randomized participants were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Convalescent Plasma | Time (in Days) to Death, Respiratory Failure, or HHHFNC at >= 15 Lpm | NA days |
| Masked Saline Placebo | Time (in Days) to Death, Respiratory Failure, or HHHFNC at >= 15 Lpm | NA days |
p-value: 0.376295% CI: [0.18, 1.96]Log Rank
Secondary
Time (in Days) to Recovery
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the Modified World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement : 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy.
Time frame: Day 1 through Day 28
Population: All randomized participants are included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Convalescent Plasma | Time (in Days) to Recovery | 6 Days |
| Masked Saline Placebo | Time (in Days) to Recovery | 6 Days |
p-value: 0.74995% CI: [0.65, 1.78]Log Rank
Secondary
Time to an Improvement of at Least One Category Using an Ordinal Scale
Number of Days until the Modified WHO Clinical Status Improved by at Least One Category Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO); 8) Death. The higher the score, the worse the outcome.
Time frame: Up through 28 days.
Population: All randomized participants were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Convalescent Plasma | Time to an Improvement of at Least One Category Using an Ordinal Scale | 6 days |
| Masked Saline Placebo | Time to an Improvement of at Least One Category Using an Ordinal Scale | 6 days |
p-value: 0.649495% CI: [0.68, 1.83]Log Rank
Secondary
Time to an Improvement of at Least Two Categories Using an Ordinal Scale
Number of Days until the Modified WHO Clinical Status Improved by at Least Two Categories Modified WHO 8-point Ordinal Scale for Clinical Improvement. The scale is as follows: 0) No clinical or Virologic evidence of infection; 1) Ambulatory, no limitation of activity; 2) Ambulatory, limitation of activity and/or home oxygen; 3) Hospitalized Mild Disease, no oxygen therapy; 4) Hospitalized Mild Disease, oxygen by mask or nasal prong; 5a) Hospitalized Severe Disease, humidified high-flow oxygen; 5b) Hospitalized Severe Disease, non-invasive ventilation; 6) Hospitalized Severe Disease, intubation and mechanical ventilation; 7) Hospitalized Severe Disease, ventilation + additional organ support-pressors, RRT, ECMO; 8) Death. The higher the score, the worse the outcome.
Time frame: Up through 28 days.
Population: All randomized participants were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Convalescent Plasma | Time to an Improvement of at Least Two Categories Using an Ordinal Scale | 7 days |
| Masked Saline Placebo | Time to an Improvement of at Least Two Categories Using an Ordinal Scale | 7 days |
p-value: 0.933895% CI: [0.59, 1.63]Log Rank
Secondary
Time to Discharge or to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for at Least 22 Hours, Whichever Occurs First
Number of Days until Initial Hospitalization Discharge or (NEWS2 \<= 2 Maintained for at Least 22 Hours) The National Early Warning Score 2 (NEWS2) score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters and ranges from 0 to 20. The NEWS2 is being used as an efficacy measure. Higher scores mean a worse outcome.
Time frame: Up through 28 days.
Population: All randomized participants were included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Convalescent Plasma | Time to Discharge or to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for at Least 22 Hours, Whichever Occurs First | 4 days |
| Masked Saline Placebo | Time to Discharge or to a National Early Warning Score 2 (NEWS2) of <= 2 Maintained for at Least 22 Hours, Whichever Occurs First | 4.5 days |
p-value: 0.568295% CI: [0.7, 1.86]Log Rank