Corona Virus InfectionPhase 1/2NCT04355728
Use of UC-MSCs for COVID-19 Patients
A Phase 1/2 study of Corona Virus Infection and ARDS, run by Camillo Ricordi at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corona Virus Infection, ARDS, ARDS, Human
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2020to 31 Oct 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Patient currently hospitalized
- Aged ≥ 18 years
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% at room air, or requiring supplemental oxygen at screening
- PaO2/FiO2 ratio < 300 mmHg
- Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan
- 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
Who cannot join
- PaO2/FiO2 ≥ 300 at the time of enrollment
- A previous MSC infusion not related to this trial
- History of Pulmonary Hypertension (WHO Class III/IV)
- History of left atrial hypertension or decompensated left heart failure.
- Pregnant or lactating patient
- Unstable arrhythmia
Show all 15Show fewer
- Patients with previous lung transplant
- Patients currently receiving chronic dialysis
- Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO)
- Presence of any active malignancy (except non-melanoma skin cancer)
- Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
- Moderate to severe liver disease (AST and ALT >5 X ULN)
- Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen
- Baseline QT prolongation
- Moribund patient not expected to survive > 24 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: Umbilical Cord-derived Mesenchymal Stem Cells for COVID-19 Patients With Acute Respiratory Distress Syndrome (ARDS)
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).
- Being tested
- Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care., Vehicle + Heparin along with best supportive care
- Keywords
- COVID-19
- Medical subject headings
- Coronavirus Infections, Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Vehicle + Heparin along with best supportive careOther
Best supportive care treatment per the treating hospital protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care. |
| 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. Receives: Other: Vehicle + Heparin along with best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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
- 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%.
- In patients receiving high flow oxygen therapy: worsening hypoxemia, as indicated by requirement of intubation and mechanical ventilation.
- New cardiac arrhythmia requiring cardioversion
- New ventricular tachycardia, ventricular fibrillation, or asystole
- A clinical scenario consistent with transfusion incompatibility or transfusion-related infection
- Cardiac arrest or death within 24h post infusion
Measured: 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).
Measured: 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.
Measured: 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
Measured: 90 days
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity
Total number of adverse events plus serious adverse events categorized by severity.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 90 days
Secondary outcomes (43)
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.
Measured: 31 Days
Survival at 60 Days Post First Infusion
Number of participants alive at 60 days post first infusion follow up.
Measured: 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.
Measured: 31 days
Ventilator-Free Days Throughout 28 Days Post Second Infusion
Number of days participants were off ventilators during 28 days post second infusion.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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
Measured: 90 days
White Blood Cell Count (WBC)
As assessed via serum blood samples.
Measured: day 6
Platelets Count
As assessed via serum blood samples.
Measured: day 6
Hemogoblin
Measures the total amount of the oxygen-carrying protein in the blood as assessed via serum blood samples.
Measured: day 6
Hematocrit
The percentage by volume of red cells in your blood as assessed via serum blood samples.
Measured: 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
Measured: day 6
Lymphocytes
Lymphocyte count as assessed via serum blood samples
Measured: 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.
Measured: 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.
Measured: Day 6
Sodium
Sodium levels as assessed by serum blood samples.
Measured: day 6
Potassium
Potassium levels as assessed via serum blood samples.
Measured: day 6
Creatinine
Creatinine levels as assessed via serum blood samples
Measured: day 6
Glucose
Glucose levels as assessed via serum blood samples
Measured: day 6
Albumin
Albumin levels as assessed via serum blood samples
Measured: day 6
Alkaline Phosphatase
Alkaline phosphatase levels as assessed via serum blood samples for the Comprehensive Metabolic Panel.
Measured: 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
Measured: 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
Measured: day 6
Total Bilirubin
Bilirubin levels as assessed via serum blood samples for the comprehensive metabolic panel.
Measured: day 6
Blood Urea Nitrogen (BUN)
Blood urea nitrogen (BUN) levels as assessed via serum blood samples for the comprehensive metabolic panel.
Measured: day 6
Calcium
Calcium levels as assessed via serum blood samples for the comprehensive metabolic panel.
Measured: day 6
Chloride
Chloride levels as assessed via serum blood samples for the comprehensive metabolic panel.
Measured: day 6
Carbon Dioxide (CO2)
Carbon Dioxide (CO2) levels as assessed via serum blood samples for the comprehensive metabolic panel.
Measured: day 6
C-Reactive Protein Levels
As assessed via serum blood samples.
Measured: day 6
Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio
As assessed via serum blood samples on day 6 (visit 8).
Measured: day 6
D-dimer Levels
As assessed via serum blood samples.
Measured: day 6
25-Hydroxy Vitamin D Levels
As assessed via serum blood samples.
Measured: day 6
Tumor Necrosis Factor-alpha (TNFα)
Analysis of TNFα in peripheral blood plasma
Measured: day 6
Tumor Necrosis Factor-beta (TNFβ)
Analysis of TNFβ in peripheral blood plasma
Measured: day 6
Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2)
Analysis of soluble tumor necrosis factor receptor 2 (sTNFR2) in peripheral blood plasma
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day 14 post first infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start25 Apr 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camillo Ricordi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Camillo Ricordi, University of Miami
- Investigators
- Camillo Ricordi, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355728
- Sponsor's protocol ID
- 20200671
- Other IDs
- 20200370
- Status last verified
- Dec 2021
- First submitted
- 13 Apr 2020
- Last updated
- 6 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord-derived Mesenchymal Stem Cells for COVID-19 Patients With Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT04355728
- Acronym / sponsor ID
- 20200671
- Keywords
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Camillo RicordiUniversity, hospital or other
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Posted 6 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| UC-MSCs Group | Experimental | Biological: Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.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 | Other: Vehicle + Heparin along with best supportive careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Patient currently hospitalized
- Aged ≥ 18 years
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% at room air, or requiring supplemental oxygen at screening
Key exclusion criteria (15 listed)
- PaO2/FiO2 ≥ 300 at the time of enrollment
- A previous MSC infusion not related to this trial
- History of Pulmonary Hypertension (WHO Class III/IV)
- History of left atrial hypertension or decompensated left heart failure.
- Pregnant or lactating patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | UC-MSCs Group |
| Vehicle + Heparin along with best supportive careBest supportive care treatment per the treating hospital protocol. | Other | Control Group |
Primary outcome
Number of Participants With Pre-Specified Infusion Associated Adverse Events
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 90 days
Total number of adverse events plus serious adverse events categorized by severity.
Subjects With Adverse Events and Serious Adverse Events by Severity
Time frame: 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
Time frame: 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
Time frame: 90 days
Total number of subjects with adverse events categorized by relatedness to treatment by a medical professional
43 secondary outcomes
Survival at 31 Days Post First Infusion
Time frame: 31 Days
Survival at 60 Days Post First Infusion
Time frame: 60 days
Time to Recovery
Time frame: 31 days
Ventilator-Free Days Throughout 28 Days Post Second Infusion
Time frame: 28 days post second infusion
Ventilator-Free Days Throughout 90 Days
Time frame: 90 days or hospital discharge, whichever is earlier
Respiratory Rate and Oxygenation Index (ROX Index)
Time frame: day 6
Oxygenation Index (OI)
Time frame: day 6
Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat)
Time frame: day 6
Sequential Organ Failure Assessment (SOFA) Scores
Time frame: Day 6
Smell Identification Test (SIT) Scores
Time frame: 90 days
White Blood Cell Count (WBC)
Time frame: day 6
Platelets Count
Time frame: day 6
Hemogoblin
Time frame: day 6
Hematocrit
Time frame: day 6
Neutrophils
Time frame: day 6
Lymphocytes
Time frame: day 6
Glomerular Filtration Rate
Time frame: day 6
Total Protein
Time frame: Day 6
Sodium
Time frame: day 6
Potassium
Time frame: day 6
Creatinine
Time frame: day 6
Glucose
Time frame: day 6
Albumin
Time frame: day 6
Alkaline Phosphatase
Time frame: day 6
Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT)
Time frame: day 6
Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT)
Time frame: day 6
Total Bilirubin
Time frame: day 6
Blood Urea Nitrogen (BUN)
Time frame: day 6
Calcium
Time frame: day 6
Chloride
Time frame: day 6
Carbon Dioxide (CO2)
Time frame: day 6
C-Reactive Protein Levels
Time frame: day 6
Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio
Time frame: day 6
D-dimer Levels
Time frame: day 6
25-Hydroxy Vitamin D Levels
Time frame: day 6
Tumor Necrosis Factor-alpha (TNFα)
Time frame: day 6
Tumor Necrosis Factor-beta (TNFβ)
Time frame: day 6
Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2)
Time frame: day 6
Viral Load by SARS-CoV-2 RT-PCR
Time frame: day 6
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion
Time frame: day 3 post first infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camillo Ricordi, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Corona Virus Infection and ARDS, run by Camillo Ricordi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Pre-Specified Infusion Associated Adverse Events (time frame: 6 and 24 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.