Acute Respiratory Distress Syndrome, ARDS, ARDS, Human, Corona Virus Infection, COVID-19
Conditions
Keywords
COVID-19
Brief summary
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).
Interventions
BIOLOGICALUmbilical 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.
OTHERVehicle + Heparin along with best supportive care
Best supportive care treatment per the treating hospital protocol.
Sponsors
Camillo Ricordi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-Blinding Trial
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Patient currently hospitalized 2. Aged ≥ 18 years 3. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent 4. Peripheral capillary oxygen saturation (SpO2) ≤ 94% at room air, or requiring supplemental oxygen at screening 5. PaO2/FiO2 ratio \< 300 mmHg 6. Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan 7. Hypoxemia requiring an increase in the fraction of inspired oxygen (FiO2) of ≥ 20% AND an increase in positive end-expiratory airway pressure (PEEP) level of 5 cm H2O or more to maintain transcutaneous oxygen saturations in the target range of 88-95%, or requirement for escalation from oxygen therapy to invasive mechanical ventilation
Exclusion criteria
1. PaO2/FiO2 ≥ 300 at the time of enrollment 2. A previous MSC infusion not related to this trial 3. History of Pulmonary Hypertension (WHO Class III/IV) 4. History of left atrial hypertension or decompensated left heart failure. 5. Pregnant or lactating patient 6. Unstable arrhythmia 7. Patients with previous lung transplant 8. Patients currently receiving chronic dialysis 9. Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO) 10. Presence of any active malignancy (except non-melanoma skin cancer) 11. Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50% 12. Moderate to severe liver disease (AST and ALT \>5 X ULN) 13. Severe chronic respiratory disease with a PaCO2 \> 50 mm Hg or the use of home oxygen 14. Baseline QT prolongation 15. Moribund patient not expected to survive \> 24 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pre-Specified Infusion Associated Adverse Events | 6 and 24 hours | 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: 1. An increase in vasopressor dose greater than or equal to the following: * Norepinephrine: 10 μg/min * Phenylephrine: 100 μg/min * Dopamine: 10 μg/kg/min * Epinephrine: 10 μg/min 2. In patients receiving mechanical ventilation: worsening hypoxemia, as assessed by a requirement for an increase of PEEP by 5 cm H2O over baseline, or requirement to increase FiO2 of \>20%. 3. In patients receiving high flow oxygen therapy: worsening hypoxemia, as indicated by requirement of intubation and mechanical ventilation. 4. New cardiac arrhythmia requiring cardioversion 5. New ventricular tachycardia, ventricular fibrillation, or asystole 6. A clinical scenario consistent with transfusion incompatibility or transfusion-related infection 7. Cardiac arrest or death within 24h post infusion |
| Number of Subjects With Serious Adverse Events by 31 Days After First Infusion | 31 days | The number of subjects experiencing serious adverse events by 31 days after the first infusion (corresponding to 28 days after the last infusion). |
| Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90 | 90 days | Safety will be reported as the percentage of participants experiencing serious adverse events through Day 90 as assessed by treating physician. |
| Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 90 days | Total number of adverse events and serious adverse events as assessed by treating physician |
| Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity | 90 days | Total number of adverse events plus serious adverse events categorized by severity. |
| Subjects With Adverse Events and Serious Adverse Events by Severity | 90 days | Total number of subjects with adverse events and serious adverse events categorized by severity. |
| Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment | 90 days | Total number of adverse events and serious adverse events categorized by relatedness to treatment defined by a medical professional. |
| Subjects With Adverse Events by Relatedness to Treatment | 90 days | Total number of subjects with adverse events categorized by relatedness to treatment by a medical professional |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sequential Organ Failure Assessment (SOFA) Scores | Day 6 | 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). |
| Smell Identification Test (SIT) Scores | 90 days | 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 |
| White Blood Cell Count (WBC) | day 6 | As assessed via serum blood samples. |
| Platelets Count | day 6 | As assessed via serum blood samples. |
| Hemogoblin | day 6 | Measures the total amount of the oxygen-carrying protein in the blood as assessed via serum blood samples. |
| Alkaline Phosphatase | day 6 | Alkaline phosphatase levels as assessed via serum blood samples for the Comprehensive Metabolic Panel. |
| Hematocrit | day 6 | The percentage by volume of red cells in your blood as assessed via serum blood samples. |
| Neutrophils | day 6 | 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 |
| Lymphocytes | day 6 | Lymphocyte count as assessed via serum blood samples |
| Glomerular Filtration Rate | day 6 | 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. |
| Total Protein | Day 6 | 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. |
| Sodium | day 6 | Sodium levels as assessed by serum blood samples. |
| Potassium | day 6 | Potassium levels as assessed via serum blood samples. |
| Creatinine | day 6 | Creatinine levels as assessed via serum blood samples |
| Glucose | day 6 | Glucose levels as assessed via serum blood samples |
| Albumin | day 6 | Albumin levels as assessed via serum blood samples |
| Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT) | day 6 | The alanine aminotransferase or serum glutamate-pyruvate transaminase (ALT or SGPT) test as assessed via serum blood samples |
| Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT) | day 6 | The aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST or SGOT) test as assessed via serum blood samples |
| Total Bilirubin | day 6 | Bilirubin levels as assessed via serum blood samples for the comprehensive metabolic panel. |
| Blood Urea Nitrogen (BUN) | day 6 | Blood urea nitrogen (BUN) levels as assessed via serum blood samples for the comprehensive metabolic panel. |
| Calcium | day 6 | Calcium levels as assessed via serum blood samples for the comprehensive metabolic panel. |
| Chloride | day 6 | Chloride levels as assessed via serum blood samples for the comprehensive metabolic panel. |
| Carbon Dioxide (CO2) | day 6 | Carbon Dioxide (CO2) levels as assessed via serum blood samples for the comprehensive metabolic panel. |
| Survival at 31 Days Post First Infusion | 31 Days | Number of participants that are alive at 31 days post first infusion follow up corresponding to 28 day post second infusion. |
| Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio | day 6 | As assessed via serum blood samples on day 6 (visit 8). |
| D-dimer Levels | day 6 | As assessed via serum blood samples. |
| 25-Hydroxy Vitamin D Levels | day 6 | As assessed via serum blood samples. |
| Tumor Necrosis Factor-alpha (TNFα) | day 6 | Analysis of TNFα in peripheral blood plasma |
| Tumor Necrosis Factor-beta (TNFβ) | day 6 | Analysis of TNFβ in peripheral blood plasma |
| Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2) | day 6 | Analysis of soluble tumor necrosis factor receptor 2 (sTNFR2) in peripheral blood plasma |
| Viral Load by SARS-CoV-2 RT-PCR | day 6 | 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). |
| Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion | 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. |
| Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion | day 6 | 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. |
| Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion | day 14 | 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. |
| Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | day 14 post first infusion | Number of participants with positive, negative, or borderline SARS-CoV-2 Immunoglobulin M (IgM)/Immunoglobulin G (IgG) serology from serum blood samples. |
| C-Reactive Protein Levels | day 6 | As assessed via serum blood samples. |
| Survival at 60 Days Post First Infusion | 60 days | Number of participants alive at 60 days post first infusion follow up. |
| Time to Recovery | 31 days | 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. |
| Ventilator-Free Days Throughout 28 Days Post Second Infusion | 28 days post second infusion | Number of days participants were off ventilators during 28 days post second infusion. |
| Ventilator-Free Days Throughout 90 Days | 90 days or hospital discharge, whichever is earlier | Number of days participants were off ventilators within up to 90 days of hospitalization. |
| Respiratory Rate and Oxygenation Index (ROX Index) | day 6 | 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. |
| Oxygenation Index (OI) | day 6 | 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). |
| Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat) | day 6 | Measuring the respiratory mechanics; positive end-expiratory pressure (PEEP) and plateau pressure (Pplat) in ventilated patients visit 8 (day 6) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Total | UC-MSCs Group | Control Group |
|---|---|---|---|
| 25-OH vitamin D levels | 22.47 ng/ml STANDARD_DEVIATION 10.68 | 21.76 ng/ml STANDARD_DEVIATION 8.48 | 23.19 ng/ml STANDARD_DEVIATION 12.85 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 4 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 8 Participants | 7 Participants |
| Age, Continuous | 58.71 years STANDARD_DEVIATION 13.63 | 58.58 years STANDARD_DEVIATION 15.93 | 58.83 years STANDARD_DEVIATION 11.61 |
| Alanine Aminotransferase (ALT) or Serum Glutamic-pyruvic Transaminase (SGPT) | 77.52 U/L STANDARD_DEVIATION 63.51 | 72.1 U/L STANDARD_DEVIATION 51.19 | 82.45 U/L STANDARD_DEVIATION 75.18 |
| Albumin for Comprehensive Metabolic Panel | 3.22 g/dL STANDARD_DEVIATION 0.44 | 3.22 g/dL STANDARD_DEVIATION 0.39 | 3.21 g/dL STANDARD_DEVIATION 0.51 |
| Alkaline Phosphatase for Comprehensive Metabolic Panel | 93.7 U/L STANDARD_DEVIATION 54.67 | 90.9 U/L STANDARD_DEVIATION 59.3 | 96.5 U/L STANDARD_DEVIATION 52.69 |
| Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio | 45.58 ratio of AA to EPA STANDARD_DEVIATION 23.88 | 45.38 ratio of AA to EPA STANDARD_DEVIATION 24.89 | 45.79 ratio of AA to EPA STANDARD_DEVIATION 23.93 |
| Aspartate Aminotransferase (AST) or Serum Glutamic-Oxaloacetic Transaminase (SGOT) | 88.62 U/L STANDARD_DEVIATION 114.86 | 55.8 U/L STANDARD_DEVIATION 31.07 | 118.45 U/L STANDARD_DEVIATION 153.16 |
| Blood Urea Nitrogen (BUN) for Comprehensive Metabolic Panel | 36.13 mg/dL STANDARD_DEVIATION 25.38 | 29.58 mg/dL STANDARD_DEVIATION 16.61 | 42.67 mg/dL STANDARD_DEVIATION 31.27 |
| Calcium for Comprehensive Metabolic Panel | 8.43 mg/dL STANDARD_DEVIATION 0.67 | 8.53 mg/dL STANDARD_DEVIATION 0.4 | 8.32 mg/dL STANDARD_DEVIATION 0.87 |
| Carbon Dioxide (CO2) for Comprehensive Metabolic Panel | 23.17 mmol/L STANDARD_DEVIATION 4.41 | 24.42 mmol/L STANDARD_DEVIATION 3.99 | 21.92 mmol/L STANDARD_DEVIATION 4.62 |
| Chloride Comprehensive Metabolic Panel | 100.75 mmol/L STANDARD_DEVIATION 5.29 | 101 mmol/L STANDARD_DEVIATION 4.29 | 100.5 mmol/L STANDARD_DEVIATION 6.33 |
| C-Reactive Protein (CRP) | 121.16 mg/L STANDARD_DEVIATION 99.19 | 97.97 mg/L STANDARD_DEVIATION 77.56 | 144.35 mg/L STANDARD_DEVIATION 115.69 |
| Creatine for Comprehensive Metabolic Panel | 1.55 mg/dL STANDARD_DEVIATION 1.46 | 1.18 mg/dL STANDARD_DEVIATION 0.77 | 1.92 mg/dL STANDARD_DEVIATION 1.88 |
| D-Dimer | 3.29 mcg/mL FEU STANDARD_DEVIATION 4.69 | 1.76 mcg/mL FEU STANDARD_DEVIATION 2.35 | 4.96 mcg/mL FEU STANDARD_DEVIATION 6.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 11 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Glomerular Filtration Rate from Comprehensive Metabolic Panel | 67.88 mL/min/1.73 m^2 STANDARD_DEVIATION 34.63 | 74.5 mL/min/1.73 m^2 STANDARD_DEVIATION 31.61 | 61.25 mL/min/1.73 m^2 STANDARD_DEVIATION 37.59 |
| Glucose for Comprehensive Metabolic Panel | 192.21 mg/dL STANDARD_DEVIATION 94.78 | 190.75 mg/dL STANDARD_DEVIATION 107.14 | 193.67 mg/dL STANDARD_DEVIATION 85.44 |
| Hematocrit from Complete Blood Count | 40.18 percentage of total blood volume STANDARD_DEVIATION 5.79 | 39.71 percentage of total blood volume STANDARD_DEVIATION 6.53 | 40.76 percentage of total blood volume STANDARD_DEVIATION 5.08 |
| Hemogoblin from Complete Blood Count | 12.69 g/dL STANDARD_DEVIATION 2.17 | 12.93 g/dL STANDARD_DEVIATION 2.04 | 12.45 g/dL STANDARD_DEVIATION 2.35 |
| Lymphocytes from Complete Blood Count | 0.95 10^3 cells/uL STANDARD_DEVIATION 0.62 | 1.15 10^3 cells/uL STANDARD_DEVIATION 0.79 | 0.72 10^3 cells/uL STANDARD_DEVIATION 0.25 |
| Neutrophils from Complete Blood Count | 11.21 10^3 cells/uL STANDARD_DEVIATION 5.36 | 9.25 10^3 cells/uL STANDARD_DEVIATION 4.8 | 13.37 10^3 cells/uL STANDARD_DEVIATION 5.33 |
| Oxygenation Index | 11.83 Index STANDARD_DEVIATION 11.5 | 8.09 Index STANDARD_DEVIATION 2.63 | 14.32 Index STANDARD_DEVIATION 14.68 |
| Panel Reactive Antibody (PRA) PRA Results Class I Negative PRA | 4 Participants | 1 Participants | 3 Participants |
| Panel Reactive Antibody (PRA) PRA Results Class I Positive PRA | 20 Participants | 11 Participants | 9 Participants |
| Panel Reactive Antibody (PRA) PRA Results Class II Negative PRA | 14 Participants | 8 Participants | 6 Participants |
| Panel Reactive Antibody (PRA) PRA Results Class II Positive PRA | 10 Participants | 4 Participants | 6 Participants |
| Plateau Pressure | 21.38 cm H2O STANDARD_DEVIATION 11.43 | 13.75 cm H2O STANDARD_DEVIATION 9.74 | 29 cm H2O STANDARD_DEVIATION 7.39 |
| Platelet count from Complete Blood Count | 336.21 10^3 cells/uL STANDARD_DEVIATION 93.88 | 329.83 10^3 cells/uL STANDARD_DEVIATION 99.52 | 342.58 10^3 cells/uL STANDARD_DEVIATION 91.83 |
| Positive End-Expiratory Pressure (PEEP) | 13.09 cm H2O STANDARD_DEVIATION 2.07 | 13.75 cm H2O STANDARD_DEVIATION 2.06 | 12.71 cm H2O STANDARD_DEVIATION 2.14 |
| Potassium for Comprehensive Metabolic Panel | 4.44 mmol/L STANDARD_DEVIATION 0.6 | 4.37 mmol/L STANDARD_DEVIATION 0.55 | 4.52 mmol/L STANDARD_DEVIATION 0.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 11 Participants | 10 Participants |
| Region of Enrollment United States | 24 participants | 12 participants | 12 participants |
| Respiratory Rate and Oxygenation Index (ROX) | 5.91 Index STANDARD_DEVIATION 6.24 | 7.36 Index STANDARD_DEVIATION 7.73 | 3.59 Index STANDARD_DEVIATION 1.13 |
| Sequential Organ Failure Assessment (SOFA) Score | 6.52 score on a scale STANDARD_DEVIATION 3.12 | 5.5 score on a scale STANDARD_DEVIATION 2.61 | 7.64 score on a scale STANDARD_DEVIATION 3.35 |
| Serology (anti-SARS-CoV-2 IgM and IgG) IgG Borderline | 1 Participants | 1 Participants | 0 Participants |
| Serology (anti-SARS-CoV-2 IgM and IgG) IgG Negative | 5 Participants | 4 Participants | 1 Participants |
| Serology (anti-SARS-CoV-2 IgM and IgG) IgG Positive | 13 Participants | 5 Participants | 8 Participants |
| Serology (anti-SARS-CoV-2 IgM and IgG) IgM Borderline | 2 Participants | 0 Participants | 2 Participants |
| Serology (anti-SARS-CoV-2 IgM and IgG) IgM Negative | 8 Participants | 6 Participants | 2 Participants |
| Serology (anti-SARS-CoV-2 IgM and IgG) IgM Positive | 9 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Female | 11 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 13 Participants | 5 Participants | 8 Participants |
| Sodium for Comprehensive Metabolic Panel | 137.75 mmol/L STANDARD_DEVIATION 4.28 | 138.92 mmol/L STANDARD_DEVIATION 3.15 | 136.58 mmol/L STANDARD_DEVIATION 5.04 |
| Total Bilirubin for Comprehensive Metabolic Panel | 0.64 mg/dL STANDARD_DEVIATION 0.32 | 0.62 mg/dL STANDARD_DEVIATION 0.39 | 0.65 mg/dL STANDARD_DEVIATION 0.25 |
| Total Protein from Comprehensive Metabolic Panel | 6.42 g/dL STANDARD_DEVIATION 0.67 | 6.39 g/dL STANDARD_DEVIATION 0.69 | 6.45 g/dL STANDARD_DEVIATION 0.68 |
| Viral Load by SARS-CoV-2 RT-PCR | 710 copies | 352 copies | 3570.50 copies |
| White Blood Count (WBC) from Complete Blood Count | 13.02 10^3 cells/uL STANDARD_DEVIATION 5.37 | 11.87 10^3 cells/uL STANDARD_DEVIATION 5.26 | 14.17 10^3 cells/uL STANDARD_DEVIATION 5.45 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 12 | 7 / 12 |
| other Total, other adverse events | 8 / 12 | 10 / 12 |
| serious Total, serious adverse events | 5 / 12 | 8 / 12 |
Outcome results
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
Time frame: 90 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UC-MSCs Group | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Adverse Events (not including SAEs) | 40 Adverse Events |
| UC-MSCs Group | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Serious Adverse Events | 6 Adverse Events |
| Control Group | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Adverse Events (not including SAEs) | 37 Adverse Events |
| Control Group | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Serious Adverse Events | 16 Adverse Events |
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.
Time frame: 90 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UC-MSCs Group | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity | Mild | 15 Adverse Events |
| UC-MSCs Group | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity | Moderate | 22 Adverse Events |
| UC-MSCs Group | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity | Severe | 9 Adverse Events |
| Control Group | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity | Mild | 13 Adverse Events |
| Control Group | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity | Moderate | 21 Adverse Events |
| Control Group | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity | Severe | 19 Adverse Events |
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.
Time frame: 90 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UC-MSCs Group | Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment | Unlikely | 3 Adverse Events |
| UC-MSCs Group | Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment | Probably | 0 Adverse Events |
| UC-MSCs Group | Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment | Possible | 1 Adverse Events |
| UC-MSCs Group | Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment | Definite | 0 Adverse Events |
| UC-MSCs Group | Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment | Unrelated | 42 Adverse Events |
| Control Group | Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment | Definite | 0 Adverse Events |
| Control Group | Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment | Unrelated | 45 Adverse Events |
| Control Group | Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment | Unlikely | 7 Adverse Events |
| Control Group | Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment | Possible | 1 Adverse Events |
| Control Group | Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment | Probably | 0 Adverse Events |
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: 1. An increase in vasopressor dose greater than or equal to the following: * Norepinephrine: 10 μg/min * Phenylephrine: 100 μg/min * Dopamine: 10 μg/kg/min * Epinephrine: 10 μg/min 2. In patients receiving mechanical ventilation: worsening hypoxemia, as assessed by a requirement for an increase of PEEP by 5 cm H2O over baseline, or requirement to increase FiO2 of \>20%. 3. In patients receiving high flow oxygen therapy: worsening hypoxemia, as indicated by requirement of intubation and mechanical ventilation. 4. New cardiac arrhythmia requiring cardioversion 5. New ventricular tachycardia, ventricular fibrillation, or asystole 6. A clinical scenario consistent with transfusion incompatibility or transfusion-related infection 7. Cardiac arrest or death within 24h post infusion
Time frame: 6 and 24 hours
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC-MSCs Group | Number of Participants With Pre-Specified Infusion Associated Adverse Events | In subjects on high flow oxygen therapy:worsening hypoxemia(req intubat, mechanical ventilat) at 6 h | 0 Participants |
| UC-MSCs Group | Number of Participants With Pre-Specified Infusion Associated Adverse Events | Number of subjects with new ventricular tachycardia, ventricular fibrillation, or asystole at 6 h | 0 Participants |
| UC-MSCs Group | Number of Participants With Pre-Specified Infusion Associated Adverse Events | In subjects receiving mechanical ventilation, Number of subjects with worsening of hypoxemia at 6 h | 1 Participants |
| UC-MSCs Group | Number of Participants With Pre-Specified Infusion Associated Adverse Events | A clinical scenario consistent with transfusion incompatibility or transfusion-rel infection at 6h | 0 Participants |
| UC-MSCs Group | Number of Participants With Pre-Specified Infusion Associated Adverse Events | Number of subjects with new cardiac arrhythmia requiring cardioversion at 6 h | 0 Participants |
| UC-MSCs Group | Number of Participants With Pre-Specified Infusion Associated Adverse Events | Number of subjects with cardiac arrest or death within 24 h post infusion | 0 Participants |
| UC-MSCs Group | Number of Participants With Pre-Specified Infusion Associated Adverse Events | Number of subjects with an increase in vasopressor dose at 6 h | 1 Participants |
| Control Group | Number of Participants With Pre-Specified Infusion Associated Adverse Events | Number of subjects with cardiac arrest or death within 24 h post infusion | 0 Participants |
| Control Group | Number of Participants With Pre-Specified Infusion Associated Adverse Events | Number of subjects with an increase in vasopressor dose at 6 h | 1 Participants |
| Control Group | Number of Participants With Pre-Specified Infusion Associated Adverse Events | In subjects receiving mechanical ventilation, Number of subjects with worsening of hypoxemia at 6 h | 1 Participants |
| Control Group | Number of Participants With Pre-Specified Infusion Associated Adverse Events | In subjects on high flow oxygen therapy:worsening hypoxemia(req intubat, mechanical ventilat) at 6 h | 0 Participants |
| Control Group | Number of Participants With Pre-Specified Infusion Associated Adverse Events | Number of subjects with new cardiac arrhythmia requiring cardioversion at 6 h | 1 Participants |
| Control Group | Number of Participants With Pre-Specified Infusion Associated Adverse Events | Number of subjects with new ventricular tachycardia, ventricular fibrillation, or asystole at 6 h | 1 Participants |
| Control Group | Number of Participants With Pre-Specified Infusion Associated Adverse Events | A clinical scenario consistent with transfusion incompatibility or transfusion-rel infection at 6h | 0 Participants |
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).
Time frame: 31 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| UC-MSCs Group | Number of Subjects With Serious Adverse Events by 31 Days After First Infusion | 2 Participants |
| Control Group | Number of Subjects With Serious Adverse Events by 31 Days After First Infusion | 8 Participants |
Comparison: The null hypothesis is the following: There is no difference in the number of subjects experiencing serious adverse events in the UC-MSC vs control group.p-value: 0.04Fisher Exact
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.
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UC-MSCs Group | Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90 | 41.67 percentage of participants |
| Control Group | Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90 | 66.67 percentage of participants |
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.
Time frame: 90 days
Population: Subjects who experience one or more AEs or SAEs within each category are counted only once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC-MSCs Group | Subjects With Adverse Events and Serious Adverse Events by Severity | Mild | 7 Participants |
| UC-MSCs Group | Subjects With Adverse Events and Serious Adverse Events by Severity | Moderate | 7 Participants |
| UC-MSCs Group | Subjects With Adverse Events and Serious Adverse Events by Severity | Severe | 5 Participants |
| Control Group | Subjects With Adverse Events and Serious Adverse Events by Severity | Mild | 5 Participants |
| Control Group | Subjects With Adverse Events and Serious Adverse Events by Severity | Moderate | 8 Participants |
| Control Group | Subjects With Adverse Events and Serious Adverse Events by Severity | Severe | 7 Participants |
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
Time frame: 90 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC-MSCs Group | Subjects With Adverse Events by Relatedness to Treatment | Unlikely | 1 Participants |
| UC-MSCs Group | Subjects With Adverse Events by Relatedness to Treatment | Probable | 0 Participants |
| UC-MSCs Group | Subjects With Adverse Events by Relatedness to Treatment | Possible | 1 Participants |
| UC-MSCs Group | Subjects With Adverse Events by Relatedness to Treatment | Defininte | 0 Participants |
| UC-MSCs Group | Subjects With Adverse Events by Relatedness to Treatment | Unrelated | 8 Participants |
| Control Group | Subjects With Adverse Events by Relatedness to Treatment | Defininte | 0 Participants |
| Control Group | Subjects With Adverse Events by Relatedness to Treatment | Unrelated | 10 Participants |
| Control Group | Subjects With Adverse Events by Relatedness to Treatment | Unlikely | 4 Participants |
| Control Group | Subjects With Adverse Events by Relatedness to Treatment | Possible | 1 Participants |
| Control Group | Subjects With Adverse Events by Relatedness to Treatment | Probable | 0 Participants |
Secondary
25-Hydroxy Vitamin D Levels
As assessed via serum blood samples.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | 25-Hydroxy Vitamin D Levels | 23.21 ng/ml | Standard Deviation 8.91 |
| Control Group | 25-Hydroxy Vitamin D Levels | 27.58 ng/ml | Standard Deviation 16.38 |
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
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT) | 64.4 U/L | Standard Deviation 38.43 |
| Control Group | Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT) | 65.67 U/L | Standard Deviation 45.04 |
Secondary
Albumin
Albumin levels as assessed via serum blood samples
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Albumin | 2.96 g/dL | Standard Deviation 0.43 |
| Control Group | Albumin | 2.73 g/dL | Standard Deviation 0.45 |
Secondary
Alkaline Phosphatase
Alkaline phosphatase levels as assessed via serum blood samples for the Comprehensive Metabolic Panel.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Alkaline Phosphatase | 136.2 U/L | Standard Deviation 68.36 |
| Control Group | Alkaline Phosphatase | 202.5 U/L | Standard Deviation 219.13 |
Secondary
Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio
As assessed via serum blood samples on day 6 (visit 8).
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio | 33.6 ratio of AA to EPA | Standard Deviation 12 |
| Control Group | Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio | 34.64 ratio of AA to EPA | Standard Deviation 13.24 |
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
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT) | 55.8 U/L | Standard Deviation 23.86 |
| Control Group | Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT) | 47 U/L | Standard Deviation 32.47 |
Secondary
Blood Urea Nitrogen (BUN)
Blood urea nitrogen (BUN) levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Blood Urea Nitrogen (BUN) | 48 mg/dL | Standard Deviation 22.28 |
| Control Group | Blood Urea Nitrogen (BUN) | 47.67 mg/dL | Standard Deviation 26.97 |
Secondary
Calcium
Calcium levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Calcium | 8.5 mg/dL | Standard Deviation 0.58 |
| Control Group | Calcium | 8.27 mg/dL | Standard Deviation 0.67 |
Secondary
Carbon Dioxide (CO2)
Carbon Dioxide (CO2) levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Carbon Dioxide (CO2) | 28.44 mmol/L | Standard Deviation 3.75 |
| Control Group | Carbon Dioxide (CO2) | 26.44 mmol/L | Standard Deviation 4.61 |
Secondary
Chloride
Chloride levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Chloride | 101.56 mmol/L | Standard Deviation 7.63 |
| Control Group | Chloride | 102.44 mmol/L | Standard Deviation 9.04 |
Secondary
C-Reactive Protein Levels
As assessed via serum blood samples.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | C-Reactive Protein Levels | 101.01 mg/L | Standard Deviation 131.05 |
| Control Group | C-Reactive Protein Levels | 112.55 mg/L | Standard Deviation 104.7 |
Secondary
Creatinine
Creatinine levels as assessed via serum blood samples
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Creatinine | 1.21 mg/dL | Standard Deviation 0.54 |
| Control Group | Creatinine | 1.24 mg/dL | Standard Deviation 0.74 |
Secondary
D-dimer Levels
As assessed via serum blood samples.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | D-dimer Levels | 6.2 mcg/ml FEU | Standard Deviation 11.29 |
| Control Group | D-dimer Levels | 4.69 mcg/ml FEU | Standard Deviation 3.38 |
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.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Glomerular Filtration Rate | 60.59 mL/min/1.73 m^2 | Standard Deviation 26.99 |
| Control Group | Glomerular Filtration Rate | 68.67 mL/min/1.73 m^2 | Standard Deviation 35.4 |
Secondary
Glucose
Glucose levels as assessed via serum blood samples
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Glucose | 153.11 mg/dL | Standard Deviation 63.99 |
| Control Group | Glucose | 183.89 mg/dL | Standard Deviation 82.33 |
Secondary
Hematocrit
The percentage by volume of red cells in your blood as assessed via serum blood samples.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Hematocrit | 37.98 percentage of red blood cells by volume | Standard Deviation 8.32 |
| Control Group | Hematocrit | 36.73 percentage of red blood cells by volume | Standard Deviation 9.56 |
Secondary
Hemogoblin
Measures the total amount of the oxygen-carrying protein in the blood as assessed via serum blood samples.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Hemogoblin | 11.93 g/dL | Standard Deviation 2.82 |
| Control Group | Hemogoblin | 11.94 g/dL | Standard Deviation 3.34 |
Secondary
Lymphocytes
Lymphocyte count as assessed via serum blood samples
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Lymphocytes | 1.38 10^3 cells/uL | Standard Deviation 1.07 |
| Control Group | Lymphocytes | 0.8 10^3 cells/uL | Standard Deviation 0.41 |
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
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Neutrophils | 9.74 10^3 cells/uL | Standard Deviation 4.27 |
| Control Group | Neutrophils | 13.4 10^3 cells/uL | Standard Deviation 5.95 |
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.
Time frame: day 14
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| UC-MSCs Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion | Class I | PRA Positive | 5 Participants |
| UC-MSCs Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion | Class I | PRA Negative | 0 Participants |
| UC-MSCs Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion | Class II | PRA Positive | 4 Participants |
| UC-MSCs Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion | Class II | PRA Negative | 1 Participants |
| Control Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion | Class II | PRA Negative | 2 Participants |
| Control Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion | Class I | PRA Positive | 3 Participants |
| Control Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion | Class II | PRA Positive | 2 Participants |
| Control Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion | Class I | PRA Negative | 1 Participants |
Comparison: The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 14 days post first infusion.p-value: 0.44Fisher Exact
Comparison: The null hypothesis is the following: There is no association between PRA (class II) status and treatment group at 14 days post first infusion.p-value: 0.5238Fisher Exact
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.
Time frame: day 3 post first infusion
Population: One subject in the control group died before day 3 post first infusion.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| UC-MSCs Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion | Class I | PRA Positive | 10 Participants |
| UC-MSCs Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion | Class I | PRA Negative | 2 Participants |
| UC-MSCs Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion | Class II | PRA Positive | 4 Participants |
| UC-MSCs Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion | Class II | PRA Negative | 8 Participants |
| Control Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion | Class II | PRA Negative | 5 Participants |
| Control Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion | Class I | PRA Positive | 11 Participants |
| Control Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion | Class II | PRA Positive | 6 Participants |
| Control Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion | Class I | PRA Negative | 0 Participants |
Comparison: The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 3 days post first infusion.p-value: 0.48Fisher Exact
Comparison: The null hypothesis is the following: There is no association between PRA (class II) status and treatment group at 3 days post first infusion.p-value: 0.41Fisher Exact
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.
Time frame: day 6
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| UC-MSCs Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion | Class I | PRA Positive | 9 Participants |
| UC-MSCs Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion | Class I | PRA Negative | 1 Participants |
| UC-MSCs Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion | Class II | PRA Positive | 5 Participants |
| UC-MSCs Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion | Class II | PRA Negative | 5 Participants |
| Control Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion | Class II | PRA Negative | 6 Participants |
| Control Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion | Class I | PRA Positive | 9 Participants |
| Control Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion | Class II | PRA Positive | 5 Participants |
| Control Group | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion | Class I | PRA Negative | 2 Participants |
Comparison: The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 6 days post first infusion.p-value: 1Fisher Exact
Comparison: The null hypothesis is the following: There is no association between PRA (Class II) status and treatment group at 6 days post first infusion.p-value: 1Fisher Exact
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.
Time frame: day 14 post first infusion
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| UC-MSCs Group | Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | IgM | Positive | 2 Participants |
| UC-MSCs Group | Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | IgM | Negative | 1 Participants |
| UC-MSCs Group | Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | IgM | Borderline | 1 Participants |
| UC-MSCs Group | Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | IgG | Positive | 4 Participants |
| UC-MSCs Group | Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | IgG | Negative | 0 Participants |
| UC-MSCs Group | Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | IgG | Borderline | 0 Participants |
| Control Group | Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | IgG | Negative | 0 Participants |
| Control Group | Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | IgM | Positive | 2 Participants |
| Control Group | Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | IgG | Positive | 2 Participants |
| Control Group | Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | IgM | Negative | 0 Participants |
| Control Group | Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | IgG | Borderline | 0 Participants |
| Control Group | Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG | IgM | Borderline | 0 Participants |
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).
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Oxygenation Index (OI) | 9.62 Index | Standard Deviation 1.43 |
| Control Group | Oxygenation Index (OI) | 12.74 Index | Standard Deviation 5.21 |
Secondary
Platelets Count
As assessed via serum blood samples.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Platelets Count | 342 10^3 cells/uL | Standard Deviation 136.33 |
| Control Group | Platelets Count | 397.89 10^3 cells/uL | Standard Deviation 135.59 |
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)
Time frame: day 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC-MSCs Group | Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat) | PEEP | 9.73 cm H2O | Standard Deviation 3.72 |
| UC-MSCs Group | Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat) | Plateau Pressure | 28.67 cm H2O | Standard Deviation 9.61 |
| Control Group | Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat) | PEEP | 11.67 cm H2O | Standard Deviation 1.53 |
| Control Group | Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat) | Plateau Pressure | 24 cm H2O | Standard Deviation 2.83 |
Secondary
Potassium
Potassium levels as assessed via serum blood samples.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Potassium | 4.25 mmol/L | Standard Deviation 0.71 |
| Control Group | Potassium | 4.37 mmol/L | Standard Deviation 0.73 |
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.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Respiratory Rate and Oxygenation Index (ROX Index) | 9.57 Index | Standard Deviation 5.23 |
| Control Group | Respiratory Rate and Oxygenation Index (ROX Index) | 7.44 Index | Standard Deviation 2.9 |
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).
Time frame: Day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Sequential Organ Failure Assessment (SOFA) Scores | 6.56 score on a scale | Standard Deviation 2.7 |
| Control Group | Sequential Organ Failure Assessment (SOFA) Scores | 6.82 score on a scale | Standard Deviation 2.36 |
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
Time frame: 90 days
Population: No participants in the study were able to complete the Smell Evaluation Test due to extenuating circumstances related to the COVID-19 pandemic.
Secondary
Sodium
Sodium levels as assessed by serum blood samples.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Sodium | 141.22 mmol/L | Standard Deviation 6.24 |
| Control Group | Sodium | 141 mmol/L | Standard Deviation 9.57 |
Secondary
Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2)
Analysis of soluble tumor necrosis factor receptor 2 (sTNFR2) in peripheral blood plasma
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2) | 26609.09 pg/mL | Standard Deviation 3071.96 |
| Control Group | Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2) | 23111.11 pg/mL | Standard Deviation 3086.03 |
p-value: 0.02195% CI: [-6404.7, -591.2]t-test, 2 sided
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.
Time frame: 31 Days
Population: One subject in the UC-MSC Group was not included in the data analysis due to failed intubation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| UC-MSCs Group | Survival at 31 Days Post First Infusion | 10 Participants |
| Control Group | Survival at 31 Days Post First Infusion | 5 Participants |
Secondary
Survival at 60 Days Post First Infusion
Number of participants alive at 60 days post first infusion follow up.
Time frame: 60 days
Population: A subject was censored due to failed intubation in the UC-MSC group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| UC-MSCs Group | Survival at 60 Days Post First Infusion | 9 Participants |
| Control Group | Survival at 60 Days Post First Infusion | 5 Participants |
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.
Time frame: 31 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UC-MSCs Group | Time to Recovery | Days by which 75% of subjects were recovered | 23 days |
| UC-MSCs Group | Time to Recovery | Days by which 50% of subjects were recovered | 15 days |
| UC-MSCs Group | Time to Recovery | Days by which 25% of subjects were recovered | 8 days |
| Control Group | Time to Recovery | Days by which 75% of subjects were recovered | NA days |
| Control Group | Time to Recovery | Days by which 50% of subjects were recovered | NA days |
| Control Group | Time to Recovery | Days by which 25% of subjects were recovered | 12 days |
Comparison: The null hypothesis is the following: There is no difference in Time to Recovery up to 31 days post infusion between the UC-MSC group and control group. Time to recovery was estimated in each group with Kaplan-Meier survival estimates. Log-rank tests were used to compare hazards between groups.p-value: 0.030795% CI: [0.088, 0.948]Log Rank
Secondary
Total Bilirubin
Bilirubin levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Total Bilirubin | 0.88 mg/dL | Standard Deviation 0.46 |
| Control Group | Total Bilirubin | 0.77 mg/dL | Standard Deviation 0.29 |
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.
Time frame: Day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | Total Protein | 5.88 g/dL | Standard Deviation 0.54 |
| Control Group | Total Protein | 5.8 g/dL | Standard Deviation 1.06 |
Secondary
Tumor Necrosis Factor-alpha (TNFα)
Analysis of TNFα in peripheral blood plasma
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UC-MSCs Group | Tumor Necrosis Factor-alpha (TNFα) | 349 pg/mL |
| Control Group | Tumor Necrosis Factor-alpha (TNFα) | 451 pg/mL |
p-value: 0.0356Wilcoxon (Mann-Whitney)
Secondary
Tumor Necrosis Factor-beta (TNFβ)
Analysis of TNFβ in peripheral blood plasma
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UC-MSCs Group | Tumor Necrosis Factor-beta (TNFβ) | 829 pg/mL |
| Control Group | Tumor Necrosis Factor-beta (TNFβ) | 1540 pg/mL |
p-value: 0.0215Wilcoxon (Mann-Whitney)
Secondary
Ventilator-Free Days Throughout 28 Days Post Second Infusion
Number of days participants were off ventilators during 28 days post second infusion.
Time frame: 28 days post second infusion
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UC-MSCs Group | Ventilator-Free Days Throughout 28 Days Post Second Infusion | 28 days |
| Control Group | Ventilator-Free Days Throughout 28 Days Post Second Infusion | 0 days |
Comparison: Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.p-value: 0.0563Wilcoxon (Mann-Whitney)
Secondary
Ventilator-Free Days Throughout 90 Days
Number of days participants were off ventilators within up to 90 days of hospitalization.
Time frame: 90 days or hospital discharge, whichever is earlier
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UC-MSCs Group | Ventilator-Free Days Throughout 90 Days | 90 days |
| Control Group | Ventilator-Free Days Throughout 90 Days | 0 days |
Comparison: Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.p-value: 0.0563Wilcoxon (Mann-Whitney)
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).
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| UC-MSCs Group | Viral Load by SARS-CoV-2 RT-PCR | 0 RNA copies/mL |
| Control Group | Viral Load by SARS-CoV-2 RT-PCR | 0 RNA copies/mL |
Secondary
White Blood Cell Count (WBC)
As assessed via serum blood samples.
Time frame: day 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UC-MSCs Group | White Blood Cell Count (WBC) | 13.43 10^3 cells/uL | Standard Deviation 4.62 |
| Control Group | White Blood Cell Count (WBC) | 15.53 10^3 cells/uL | Standard Deviation 5.6 |