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| ID | Type | Description | Link |
|---|---|---|---|
| 20200370 | Other Identifier | Secondary Protocol ID |
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The purpose of this research study is to learn about the safety and efficacy of human umbilical cord derived Mesenchymal Stem Cells (UC-MSC) for treatment of COVID-19 Patients with Severe Complications of Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC-MSCs Group | Experimental | Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. |
|
| Control Group | Placebo Comparator | Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care. | Biological | UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pre-Specified Infusion Associated Adverse Events | Safety as defined by the number of pre-specified infusion associated adverse events as assessed by treating physician. Any of the following occurring within 6 h post each infusion:
| 6 and 24 hours |
| Number of Subjects With Serious Adverse Events by 31 Days After First Infusion | The number of subjects experiencing serious adverse events by 31 days after the first infusion (corresponding to 28 days after the last infusion). | 31 days |
| Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90 | Safety will be reported as the percentage of participants experiencing serious adverse events through Day 90 as assessed by treating physician. | 90 days |
| Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Total number of adverse events and serious adverse events as assessed by treating physician | 90 days |
| Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 31 Days Post First Infusion | Number of participants that are alive at 31 days post first infusion follow up corresponding to 28 day post second infusion. | 31 Days |
| Survival at 60 Days Post First Infusion |
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Inclusion Criteria:
Patients >/= 18 years old diagnosed with COVID-19 (as evaluated by PCR test confirming infection with SARS-CoV-2) will be eligible for inclusion if they meet all of the below criteria. Inclusion criteria must all be present within a 24-hour time period at the time of enrollment:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Camillo Ricordi, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Research Institute, University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | UC-MSCs Group | Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment. |
| FG001 | Control Group | Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | UC-MSCs Group | Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Pre-Specified Infusion Associated Adverse Events | Safety as defined by the number of pre-specified infusion associated adverse events as assessed by treating physician. Any of the following occurring within 6 h post each infusion:
| In the UC-MSC treatment group, 4 participants were on mechanical ventilation and 8 participants were receiving high flow oxygen therapy. In the control group 7 participants were on mechanical ventilation and 5 participants were receiving high flow oxygen therapy. | Posted | Count of Participants | Participants | 6 and 24 hours |
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UC-MSCs Group | Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Bleeding 2ry to Clostridium Difficile Infection | Gastrointestinal disorders | CTCAE Version 5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | CTCAE Version 5.0 | Systematic Assessment |
The inferences we make from the efficacy results observed in this phase 1/2a trial in 24 subjects, including the outcome of survival, are still subject to limitations of sample size and potential bias because of factors we were not yet aware of.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Camillo Ricordi | University of Miami | 305-243-6913 | ricordi@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2021 | Oct 14, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D012128 | Respiratory Distress Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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The trial has two groups, each with 12 subjects (n=24). All eligible subjects will be randomized to either the treatment group or standard of care, and randomization will be stratified by ARDS severity.
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Double-Blinding Trial
| Vehicle + Heparin along with best supportive care | Other | Best supportive care treatment per the treating hospital protocol. |
|
Total number of adverse events plus serious adverse events categorized by severity. |
| 90 days |
| Subjects With Adverse Events and Serious Adverse Events by Severity | Total number of subjects with adverse events and serious adverse events categorized by severity. | 90 days |
| Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment | Total number of adverse events and serious adverse events categorized by relatedness to treatment defined by a medical professional. | 90 days |
| Subjects With Adverse Events by Relatedness to Treatment | Total number of subjects with adverse events categorized by relatedness to treatment by a medical professional | 90 days |
Number of participants alive at 60 days post first infusion follow up.
| 60 days |
| Time to Recovery | Time to discharge or, if the subject was hospitalized, no longer requiring supplemental oxygen and no longer requiring COVID-19-related medical care by 31 days. The numbers represent days at which 25%, 50%, 75% subjects within the treatment group had recovered. | 31 days |
| Ventilator-Free Days Throughout 28 Days Post Second Infusion | Number of days participants were off ventilators during 28 days post second infusion. | 28 days post second infusion |
| Ventilator-Free Days Throughout 90 Days | Number of days participants were off ventilators within up to 90 days of hospitalization. | 90 days or hospital discharge, whichever is earlier |
| Respiratory Rate and Oxygenation Index (ROX Index) | Respiratory Rate-Oxygenation (ROX) index is defined as the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ Fraction of inspired oxygen (FiO2) to respiratory rate. This index can be used in the assessment of disease progression and the risk of intubation in COVID-19 patients with pneumonia. | day 6 |
| Oxygenation Index (OI) | Measure of the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy). The calculation for Oxygenation index is ((FIO2 * Mean airway pressure)/partial pressure of oxygen). | day 6 |
| Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat) | Measuring the respiratory mechanics; positive end-expiratory pressure (PEEP) and plateau pressure (Pplat) in ventilated patients visit 8 (day 6) | day 6 |
| Sequential Organ Failure Assessment (SOFA) Scores | Sequential Organ Failure Assessment (SOFA) Scores is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from a minimum of 0 (normal) to a maximum of 4 (high degree of dysfunction/failure). The total score corresponds to the sum of the six different scores of the organ systems. In total, the minimum SOFA score is 0 (normal) and the maximum SOFA score is 24 (highest degree dysfunction/failure). | Day 6 |
| Smell Identification Test (SIT) Scores | SIT measures the participant's sense of smell. SIT has a total score ranging from 0 to 40 with the higher the score indicating a more normal sense of smell | 90 days |
| White Blood Cell Count (WBC) | As assessed via serum blood samples. | day 6 |
| Platelets Count | As assessed via serum blood samples. | day 6 |
| Hemogoblin | Measures the total amount of the oxygen-carrying protein in the blood as assessed via serum blood samples. | day 6 |
| Hematocrit | The percentage by volume of red cells in your blood as assessed via serum blood samples. | day 6 |
| Neutrophils | the amount of immune cells (that is one of the first cell types to travel to the site of an infection) as assessed via serum blood samples | day 6 |
| Lymphocytes | Lymphocyte count as assessed via serum blood samples | day 6 |
| Glomerular Filtration Rate | Glomerular filtration rate (GFR) as assessed via serum blood samples to check how well the kidneys are working. It estimates how much blood passes through the glomeruli each minute. | day 6 |
| Total Protein | Total protein as assessed via serum blood samples as a part of the comprehensive metabolic panel (CMP). It is a measurement of the sum of albumin and globulins. | Day 6 |
| Sodium | Sodium levels as assessed by serum blood samples. | day 6 |
| Potassium | Potassium levels as assessed via serum blood samples. | day 6 |
| Creatinine | Creatinine levels as assessed via serum blood samples | day 6 |
| Glucose | Glucose levels as assessed via serum blood samples | day 6 |
| Albumin | Albumin levels as assessed via serum blood samples | day 6 |
| Alkaline Phosphatase | Alkaline phosphatase levels as assessed via serum blood samples for the Comprehensive Metabolic Panel. | day 6 |
| Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT) | The alanine aminotransferase or serum glutamate-pyruvate transaminase (ALT or SGPT) test as assessed via serum blood samples | day 6 |
| Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT) | The aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST or SGOT) test as assessed via serum blood samples | day 6 |
| Total Bilirubin | Bilirubin levels as assessed via serum blood samples for the comprehensive metabolic panel. | day 6 |
| Blood Urea Nitrogen (BUN) | Blood urea nitrogen (BUN) levels as assessed via serum blood samples for the comprehensive metabolic panel. | day 6 |
| Calcium | Calcium levels as assessed via serum blood samples for the comprehensive metabolic panel. | day 6 |
| Chloride | Chloride levels as assessed via serum blood samples for the comprehensive metabolic panel. | day 6 |
| Carbon Dioxide (CO2) | Carbon Dioxide (CO2) levels as assessed via serum blood samples for the comprehensive metabolic panel. | day 6 |
| C-Reactive Protein Levels | As assessed via serum blood samples. | day 6 |
| Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio | As assessed via serum blood samples on day 6 (visit 8). | day 6 |
| D-dimer Levels | As assessed via serum blood samples. | day 6 |
| 25-Hydroxy Vitamin D Levels | As assessed via serum blood samples. | day 6 |
| Tumor Necrosis Factor-alpha (TNFα) | Analysis of TNFα in peripheral blood plasma | day 6 |
| Tumor Necrosis Factor-beta (TNFβ) | Analysis of TNFβ in peripheral blood plasma | day 6 |
| Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2) | Analysis of soluble tumor necrosis factor receptor 2 (sTNFR2) in peripheral blood plasma | day 6 |
| Viral Load by SARS-CoV-2 RT-PCR | Viral load as assessed in blood plasma for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) via Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). | day 6 |
| Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion | Number of participants reporting panel reactive antibody (PRA) positivity at Day 3 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants. | day 3 post first infusion |
| Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion | Number of participants reporting panel reactive antibody (PRA) positivity at Day 6 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants. | day 6 |
| Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion | Number of participants reporting panel reactive antibody (PRA) positivity at Day 14 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants. | day 14 |
| Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | Number of participants with positive, negative, or borderline SARS-CoV-2 Immunoglobulin M (IgM)/Immunoglobulin G (IgG) serology from serum blood samples. | day 14 post first infusion |
| BG001 | Control Group | Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Hemogoblin from Complete Blood Count | Mean | Standard Deviation | g/dL |
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| Hematocrit from Complete Blood Count | Data missing. CBC with differential at baseline was not done in a subset of patients. | Mean | Standard Deviation | percentage of total blood volume |
|
| White Blood Count (WBC) from Complete Blood Count | Mean | Standard Deviation | 10^3 cells/uL |
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| Neutrophils from Complete Blood Count | Data missing. CBC with differential at baseline was not done in a subset of patients. | Mean | Standard Deviation | 10^3 cells/uL |
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| Lymphocytes from Complete Blood Count | Data missing. CBC with differential at baseline was not done in a subset of patients. | Mean | Standard Deviation | 10^3 cells/uL |
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| Platelet count from Complete Blood Count | Mean | Standard Deviation | 10^3 cells/uL |
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| Glomerular Filtration Rate from Comprehensive Metabolic Panel | Mean | Standard Deviation | mL/min/1.73 m^2 |
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| Total Protein from Comprehensive Metabolic Panel | Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients. | Mean | Standard Deviation | g/dL |
|
| Sodium for Comprehensive Metabolic Panel | Mean | Standard Deviation | mmol/L |
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| Potassium for Comprehensive Metabolic Panel | Mean | Standard Deviation | mmol/L |
|
| Creatine for Comprehensive Metabolic Panel | Mean | Standard Deviation | mg/dL |
|
| Glucose for Comprehensive Metabolic Panel | Mean | Standard Deviation | mg/dL |
|
| Albumin for Comprehensive Metabolic Panel | Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients. | Mean | Standard Deviation | g/dL |
|
| Alkaline Phosphatase for Comprehensive Metabolic Panel | Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients. | Mean | Standard Deviation | U/L |
|
| Alanine Aminotransferase (ALT) or Serum Glutamic-pyruvic Transaminase (SGPT) | Alanine Aminotransferase (ALT) or serum glutamic-pyruvic transaminase (SGPT) for comprehensive metabolic panel as assessed from serum blood samples. | Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients. | Mean | Standard Deviation | U/L |
|
| Aspartate Aminotransferase (AST) or Serum Glutamic-Oxaloacetic Transaminase (SGOT) | Aspartate Aminotransferase (AST) or Serum Glutamic-Oxaloacetic Transaminase (SGOT) for the comprehensive metabolic panel assessed from serum blood samples. | Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients. | Mean | Standard Deviation | U/L |
|
| Total Bilirubin for Comprehensive Metabolic Panel | Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients. | Mean | Standard Deviation | mg/dL |
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| Blood Urea Nitrogen (BUN) for Comprehensive Metabolic Panel | Mean | Standard Deviation | mg/dL |
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| Calcium for Comprehensive Metabolic Panel | Mean | Standard Deviation | mg/dL |
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| Chloride Comprehensive Metabolic Panel | Mean | Standard Deviation | mmol/L |
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| Carbon Dioxide (CO2) for Comprehensive Metabolic Panel | Mean | Standard Deviation | mmol/L |
|
| Oxygenation Index | Measure of the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy). The calculation for Oxygenation index is ((FIO2 * Mean airway pressure)/partial pressure of oxygen). | Data missing. Oxidation Index is only measured and calculated in ventilated patients. | Mean | Standard Deviation | Index |
|
| Positive End-Expiratory Pressure (PEEP) | Data missing. PEEP is only measured in patients on ventilator. | Mean | Standard Deviation | cm H2O |
|
| Plateau Pressure | Plateau pressure as assessed for patients on a ventilator | Data missing. Plateau Pressure is only measured in patients on ventilator. | Mean | Standard Deviation | cm H2O |
|
| Sequential Organ Failure Assessment (SOFA) Score | Sequential Organ Failure Assessment (SOFA) Scores is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from a minimum of 0 (normal) to a maximum of 4 (high degree of dysfunction/failure). Totaling a maximum SOFA score of 24 and minimum of 0. | Data missing. | Mean | Standard Deviation | score on a scale |
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| C-Reactive Protein (CRP) | Mean | Standard Deviation | mg/L |
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| D-Dimer | D-dimer as assessed from serum blood samples. | data missing. Collected in a tube that has been recalled by the manufacturer so test was canceled by Quest | Mean | Standard Deviation | mcg/mL FEU |
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| Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio | ratio of AA to EPA as assessed via serum blood samples. | Mean | Standard Deviation | ratio of AA to EPA |
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| 25-OH vitamin D levels | Mean | Standard Deviation | ng/ml |
|
| Respiratory Rate and Oxygenation Index (ROX) | The ROX index is the measure of the ratio of pulse oximetry/fraction of inspired oxygen (SpO2/FiO2) to respiratory rate (RR). The ROX index is used as a predictor of the need to intubate in patients receiving HFNC oxygen therapy; performed at 2, 6 and 12 hours. ROX at 2, 6 and 12 hours after HFNC initiation was associated with a lower risk for intubation. For a ROX Index <3.85, risk of HFNC failure is high. If ROX Index 3.85 to <4.88, the scoring could be repeated one or two hours later for further evaluation. | data missing. Some patients were on a ventilator. Patients only on HFNC have ROX scores. | Mean | Standard Deviation | Index |
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| Viral Load by SARS-CoV-2 RT-PCR | Viral load as assessed in blood plasma for SARS-CoV-2 | Median | Inter-Quartile Range | copies |
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| Panel Reactive Antibody (PRA) | Panel Reactive Antibody (PRA) for Class I and Class II assessed via serum blood samples | Count of Participants | Participants |
|
| Serology (anti-SARS-CoV-2 IgM and IgG) | Serology (anti-SARS-CoV-2 IgM and IgG) analyzed in blood serum samples. | These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group. | Count of Participants | Participants |
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| Primary | Number of Subjects With Serious Adverse Events by 31 Days After First Infusion | The number of subjects experiencing serious adverse events by 31 days after the first infusion (corresponding to 28 days after the last infusion). | Posted | Count of Participants | Participants | 31 days |
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| Primary | Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90 | Safety will be reported as the percentage of participants experiencing serious adverse events through Day 90 as assessed by treating physician. | Posted | Number | percentage of participants | 90 days |
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| Primary | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Total number of adverse events and serious adverse events as assessed by treating physician | Posted | Number | Adverse Events | 90 days |
|
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| Primary | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity | Total number of adverse events plus serious adverse events categorized by severity. | Posted | Number | Adverse Events | 90 days |
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| Primary | Subjects With Adverse Events and Serious Adverse Events by Severity | Total number of subjects with adverse events and serious adverse events categorized by severity. | Subjects who experience one or more AEs or SAEs within each category are counted only once. | Posted | Count of Participants | Participants | 90 days |
|
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| Primary | Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment | Total number of adverse events and serious adverse events categorized by relatedness to treatment defined by a medical professional. | Posted | Number | Adverse Events | 90 days |
|
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| Primary | Subjects With Adverse Events by Relatedness to Treatment | Total number of subjects with adverse events categorized by relatedness to treatment by a medical professional | Posted | Count of Participants | Participants | 90 days |
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| Secondary | Survival at 31 Days Post First Infusion | Number of participants that are alive at 31 days post first infusion follow up corresponding to 28 day post second infusion. | One subject in the UC-MSC Group was not included in the data analysis due to failed intubation. | Posted | Count of Participants | Participants | 31 Days |
|
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| Secondary | Survival at 60 Days Post First Infusion | Number of participants alive at 60 days post first infusion follow up. | A subject was censored due to failed intubation in the UC-MSC group. | Posted | Count of Participants | Participants | 60 days |
|
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| Secondary | Time to Recovery | Time to discharge or, if the subject was hospitalized, no longer requiring supplemental oxygen and no longer requiring COVID-19-related medical care by 31 days. The numbers represent days at which 25%, 50%, 75% subjects within the treatment group had recovered. | Posted | Number | 95% Confidence Interval | days | 31 days |
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| Secondary | Ventilator-Free Days Throughout 28 Days Post Second Infusion | Number of days participants were off ventilators during 28 days post second infusion. | In the UC-MSC treatment group one subject was not included in the analysis due to censoring and another subject was not included due to loss to follow-up. In the control group one subject was not included in the analysis due to discharge against medical advice. | Posted | Median | Inter-Quartile Range | days | 28 days post second infusion |
|
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|
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| Secondary | Ventilator-Free Days Throughout 90 Days | Number of days participants were off ventilators within up to 90 days of hospitalization. | In the UC-MSC treatment group one subject was not included in the analysis due to censoring and another subject was not included due to loss to follow-up. In the control group one subject was not included in the analysis due to discharge against medical advice. | Posted | Median | Inter-Quartile Range | days | 90 days or hospital discharge, whichever is earlier |
|
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| Secondary | Respiratory Rate and Oxygenation Index (ROX Index) | Respiratory Rate-Oxygenation (ROX) index is defined as the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ Fraction of inspired oxygen (FiO2) to respiratory rate. This index can be used in the assessment of disease progression and the risk of intubation in COVID-19 patients with pneumonia. | ROX index was only measured for patients receiving HFNC and/or not intubated patients. Three patients were ventilated in the UC-MSC group, one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, two patients data was not collected. In the control group one subject was not included in the analysis due to death before day 6, three patients were ventilated, and one patient data was not collected. | Posted | Mean | Standard Deviation | Index | day 6 |
|
|
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| Secondary | Oxygenation Index (OI) | Measure of the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy). The calculation for Oxygenation index is ((FIO2 * Mean airway pressure)/partial pressure of oxygen). | Oxidation Index is only measured and calculated in ventilated patients, therefore 3 patients in the UC-MSC group were included and 3 patients in the control group were included. | Posted | Mean | Standard Deviation | Index | day 6 |
|
|
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| Secondary | Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat) | Measuring the respiratory mechanics; positive end-expiratory pressure (PEEP) and plateau pressure (Pplat) in ventilated patients visit 8 (day 6) | PEEP and Plateau pressure are only measured in ventilated patients, therefore 3 patients in the UC-MSC group were included and 3 patients in the control group were included. | Posted | Mean | Standard Deviation | cm H2O | day 6 |
|
|
|
| Secondary | Sequential Organ Failure Assessment (SOFA) Scores | Sequential Organ Failure Assessment (SOFA) Scores is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from a minimum of 0 (normal) to a maximum of 4 (high degree of dysfunction/failure). The total score corresponds to the sum of the six different scores of the organ systems. In total, the minimum SOFA score is 0 (normal) and the maximum SOFA score is 24 (highest degree dysfunction/failure). | In the UC-MSC treatment group one subject was not included in the analysis due to death and 2 subjects were not included due to discharge on day 6. In the control group one subject was not included in the analysis due to death before day 6. | Posted | Mean | Standard Deviation | score on a scale | Day 6 |
|
|
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| Secondary | Smell Identification Test (SIT) Scores | SIT measures the participant's sense of smell. SIT has a total score ranging from 0 to 40 with the higher the score indicating a more normal sense of smell | No participants in the study were able to complete the Smell Evaluation Test due to extenuating circumstances related to the COVID-19 pandemic. | Posted | 90 days |
|
|
| Secondary | White Blood Cell Count (WBC) | As assessed via serum blood samples. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | 10^3 cells/uL | day 6 |
|
|
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| Secondary | Platelets Count | As assessed via serum blood samples. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | 10^3 cells/uL | day 6 |
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|
| Secondary | Hemogoblin | Measures the total amount of the oxygen-carrying protein in the blood as assessed via serum blood samples. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | g/dL | day 6 |
|
|
|
| Secondary | Hematocrit | The percentage by volume of red cells in your blood as assessed via serum blood samples. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | percentage of red blood cells by volume | day 6 |
|
|
|
| Secondary | Neutrophils | the amount of immune cells (that is one of the first cell types to travel to the site of an infection) as assessed via serum blood samples | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and two subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | 10^3 cells/uL | day 6 |
|
|
|
| Secondary | Lymphocytes | Lymphocyte count as assessed via serum blood samples | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and two subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | 10^3 cells/uL | day 6 |
|
|
|
| Secondary | Glomerular Filtration Rate | Glomerular filtration rate (GFR) as assessed via serum blood samples to check how well the kidneys are working. It estimates how much blood passes through the glomeruli each minute. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | day 6 |
|
|
|
| Secondary | Total Protein | Total protein as assessed via serum blood samples as a part of the comprehensive metabolic panel (CMP). It is a measurement of the sum of albumin and globulins. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected. | Posted | Mean | Standard Deviation | g/dL | Day 6 |
|
|
|
| Secondary | Sodium | Sodium levels as assessed by serum blood samples. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | mmol/L | day 6 |
|
|
|
| Secondary | Potassium | Potassium levels as assessed via serum blood samples. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | mmol/L | day 6 |
|
|
|
| Secondary | Creatinine | Creatinine levels as assessed via serum blood samples | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | mg/dL | day 6 |
|
|
|
| Secondary | Glucose | Glucose levels as assessed via serum blood samples | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | mg/dL | day 6 |
|
|
|
| Secondary | Albumin | Albumin levels as assessed via serum blood samples | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected. | Posted | Mean | Standard Deviation | g/dL | day 6 |
|
|
|
| Secondary | Alkaline Phosphatase | Alkaline phosphatase levels as assessed via serum blood samples for the Comprehensive Metabolic Panel. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected. | Posted | Mean | Standard Deviation | U/L | day 6 |
|
|
|
| Secondary | Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT) | The alanine aminotransferase or serum glutamate-pyruvate transaminase (ALT or SGPT) test as assessed via serum blood samples | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected. | Posted | Mean | Standard Deviation | U/L | day 6 |
|
|
|
| Secondary | Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT) | The aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST or SGOT) test as assessed via serum blood samples | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected. | Posted | Mean | Standard Deviation | U/L | day 6 |
|
|
|
| Secondary | Total Bilirubin | Bilirubin levels as assessed via serum blood samples for the comprehensive metabolic panel. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected. | Posted | Mean | Standard Deviation | mg/dL | day 6 |
|
|
|
| Secondary | Blood Urea Nitrogen (BUN) | Blood urea nitrogen (BUN) levels as assessed via serum blood samples for the comprehensive metabolic panel. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | mg/dL | day 6 |
|
|
|
| Secondary | Calcium | Calcium levels as assessed via serum blood samples for the comprehensive metabolic panel. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | mg/dL | day 6 |
|
|
|
| Secondary | Chloride | Chloride levels as assessed via serum blood samples for the comprehensive metabolic panel. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | mmol/L | day 6 |
|
|
|
| Secondary | Carbon Dioxide (CO2) | Carbon Dioxide (CO2) levels as assessed via serum blood samples for the comprehensive metabolic panel. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected. | Posted | Mean | Standard Deviation | mmol/L | day 6 |
|
|
|
| Secondary | C-Reactive Protein Levels | As assessed via serum blood samples. | In the UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and data was missing for two subjects. In the control group one subject was not included in the analysis due to death before day 6. | Posted | Mean | Standard Deviation | mg/L | day 6 |
|
|
|
| Secondary | Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio | As assessed via serum blood samples on day 6 (visit 8). | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6. In the control group one subject was not included in the analysis due to death before day 6. | Posted | Mean | Standard Deviation | ratio of AA to EPA | day 6 |
|
|
|
| Secondary | D-dimer Levels | As assessed via serum blood samples. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6 and one subject data was not collected. | Posted | Mean | Standard Deviation | mcg/ml FEU | day 6 |
|
|
|
| Secondary | 25-Hydroxy Vitamin D Levels | As assessed via serum blood samples. | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6. In the control group one subject was not included in the analysis due to death before day 6. | Posted | Mean | Standard Deviation | ng/ml | day 6 |
|
|
|
| Secondary | Tumor Necrosis Factor-alpha (TNFα) | Analysis of TNFα in peripheral blood plasma | In the UC-MSC treatment group one subject was not included in the analysis due to failed intubation. In the control group one subject was not included in the analysis because of death before day 6 blood draw. | Posted | Median | Inter-Quartile Range | pg/mL | day 6 |
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|
|
|
| Secondary | Tumor Necrosis Factor-beta (TNFβ) | Analysis of TNFβ in peripheral blood plasma | In the UC-MSC treatment group one subject was not included in the analysis due to failed intubation. In the control group one subject was not included in the analysis because of death before day 6 blood draw. | Posted | Median | Inter-Quartile Range | pg/mL | day 6 |
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|
|
|
| Secondary | Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2) | Analysis of soluble tumor necrosis factor receptor 2 (sTNFR2) in peripheral blood plasma | In the UC-MSC treatment group one subject was not included in the analysis due to failed intubation. In the control group one subject was not included in the analysis because of death before day 6 blood draw and data was unavailable for two patients. | Posted | Mean | Standard Deviation | pg/mL | day 6 |
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|
|
|
| Secondary | Viral Load by SARS-CoV-2 RT-PCR | Viral load as assessed in blood plasma for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) via Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). | The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6. In the control group one subject was not included in the analysis due to death before day 6. | Posted | Median | Inter-Quartile Range | RNA copies/mL | day 6 |
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|
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| Secondary | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion | Number of participants reporting panel reactive antibody (PRA) positivity at Day 3 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants. | One subject in the control group died before day 3 post first infusion. | Posted | Count of Participants | Participants | day 3 post first infusion |
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|
|
|
| Secondary | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion | Number of participants reporting panel reactive antibody (PRA) positivity at Day 6 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants. | In the UC-MSC group one patient was censored and died before day 6 and one patient recovered before day 6 and left the hospital. In the control group on patient died before day 6 post first infusion. | Posted | Count of Participants | Participants | day 6 |
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|
|
| Secondary | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion | Number of participants reporting panel reactive antibody (PRA) positivity at Day 14 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants. | In the UC-MSC group one patient was censored and died before day 6, 6 patients left the hospital before day 6 post first infusion. In the control group 4 patients died, 3 patients left the hospital and one left hospital against medical advice before day 6 post first infusion. | Posted | Count of Participants | Participants | day 14 |
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| Secondary | Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | Number of participants with positive, negative, or borderline SARS-CoV-2 Immunoglobulin M (IgM)/Immunoglobulin G (IgG) serology from serum blood samples. | These analyses were implemented in a protocol version that did not apply to 2 patients of the UC-MSC treatment group and 3 patients of the control group. In the UC-MSC group one patient was censored and died before day 6, 4 patients left the hospital before day 6 post first infusion and in one patient blood was not drawn. In the control group 3 patients died, 3 patients left the hospital and one left hospital against medical advice before day 6 post first infusion. | Posted | Count of Participants | Participants | day 14 post first infusion |
|
|
|
| 3 |
| 12 |
| 5 |
| 12 |
| 8 |
| 12 |
| EG001 | Control Group | Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment. Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol. | 7 | 12 | 8 | 12 | 10 | 12 |
| Colon Perforation | Gastrointestinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Cardiact Arrest-Death due to Difficult Intubation | Cardiac disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Acute respiratory Failure 2ry to COVID-Death | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Death-Acute Hypoxemic Respiratory Failure Secondary to COVID-19 Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Psychosis | Psychiatric disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Cardiac Arrest/Pulseless Electrical Activity Cardiac Arrest/Cardiac Arrest Secondary to Acute Respir | Cardiac disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Traumatic Tension Pneumotorax post-CPR | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Severe Respiratory Acidosis | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| [DEATH] Multisystem Organ Failure (Death)/Multiple Organ Dysfunction Syndrome-Death | General disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| [DEATH] Cardiac Arrest-Death/Cardiopulmonary Arrest-Death/Asystole -Death | Cardiac disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Severe Metabolic Acidosis | Metabolism and nutrition disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Septic Shock-Hospital acquired Pseudomona Aeruginosa bacteremia | Infections and infestations | CTCAE Version 5.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Exacerbation of COVID ARDS-Septic Shock | Infections and infestations | CTCAE Version 5.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Tachycardia after infusion of Investigational Product | Cardiac disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Clostridium Difficile Infection | Gastrointestinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Mild Gastrointestinal Bleeding | Gastrointestinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Transaminitis/Transaminitis-Liver Shock | Hepatobiliary disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Increased ALT, AST, and Alkaline Phosphatase | Hepatobiliary disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Increased Direct Bilirubin | Hepatobiliary disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Abnormal Urinalysis | Renal and urinary disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Candiduria | Renal and urinary disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Leukocytosis/Leukocytosis (Increased WBC) | Blood and lymphatic system disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Severe Thrombocytopenia | Blood and lymphatic system disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Thrombocytopenia/Heparin-induced Thrombocytopenia | Blood and lymphatic system disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Bilateral Common Femoral Vein DVT | Vascular disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Candida Albicans Fungemia | Infections and infestations | CTCAE Version 5.0 | Systematic Assessment |
|
| Fever | General disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Mild Hyponatremia | Metabolism and nutrition disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| MRSA Bacteremia | Infections and infestations | CTCAE Version 5.0 | Systematic Assessment |
|
| Paenebacillus Pabuli Bacteremia | Infections and infestations | CTCAE Version 5.0 | Systematic Assessment |
|
| Positive Blood Culture Streptococcus Mitis and Streptococcus Oralis | Infections and infestations | CTCAE Version 5.0 | Systematic Assessment |
|
| Staphylococcus haemolyticus bacteremia and Candida orthopsilosi Fungemia | Infections and infestations | CTCAE Version 5.0 | Systematic Assessment |
|
| Staphylococcus Hominis Bacteremia/Staphylococcus Bacteremia | Infections and infestations | CTCAE Version 5.0 | Systematic Assessment |
|
| Left Calf Collection | Musculoskeletal and connective tissue disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Dysconjugated gaze | Nervous system disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Acute Kidney Injury/Oliguric Acute Kidney Injury/ Anuric Acute Kidney Injury/Acute Kidney Injury (AK | Renal and urinary disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Pneumoperitoneum | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Aspiration Pneumonitis, suspected | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Bradypnea | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Enterococcus Faecalis, Klebsiella Pneumoniae, Candida Auris/Duobushaemulonis in bronchial aspirate | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Enterococcus Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| MRSA Hospital Acquired Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
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| Respiratory Failure - Intubation/Hypoxemic respiratory failure requiring intubation and mechanical v | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Subcutaneous Emphysema | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Ventilator Acquired Pneumonia (VAP) with Pseudomona aureginosa | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
| Worsening of Hypoxemia/Deterioration of Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE Version 5.0 | Systematic Assessment |
|
Not provided
Not provided
| D007239 |
| Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Negative PRA |
|
| Borderline |
|
| Negative |
|
| Borderline |
|
| Severe |
|
| Severe |
|
| Possible |
|
| Probably |
|
| Definite |
|
| Possible |
|
| Probable |
|
| Defininte |
|
| Days by which 25% of subjects were recovered |
|
| Plateau Pressure |
|
|
| Class II |
|
| Fisher Exact |
| 0.41 |
| Superiority |
| Class II |
|
| Fisher Exact |
| 1.00 |
| Superiority |
| Class II |
|
| Fisher Exact |
| 0.5238 |
| Superiority |
| Borderline |
|
| IgG |
|