Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19 (COVID-19)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04490486|
Recruitment Status : Not yet recruiting
First Posted : July 29, 2020
Last Update Posted : September 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Acute Respiratory Distress Syndrome Corona Virus Infection||Biological: UCMSCs Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase I, Randomized, Double Blinded, Placebo Control Study to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19 With Moderate to Severe Symptoms|
|Estimated Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||June 1, 2024|
|Estimated Study Completion Date :||June 1, 2024|
Experimental: Group 1: (UCMSCs)
Participants in this group will receive the 2 intravenous (IV) UCMSCs intervention on day 0 and day 3.
100 x 106 (100 million) UCMSCs delivered via peripheral intravenous infusion.
Placebo Comparator: Group 2: (Placebo)
Participants in this group will receive the placebo, a solution of 1% human serum albumin in Plasmalyte A, on day 0 and day 3.
Placebo, a solution of 1% human serum albumin in Plasmalyte A, delivered via peripheral intravenous infusion
- Percent of participants with treatment related Serious Adverse Events (SAE) [ Time Frame: 12 months ]Safety of UCMSCs will be reported as the percentage of participants in each treatment group that experienced a treatment related SAEs.
- Change in inflammatory marker levels [ Time Frame: Baseline, Day 30 ]Change in serum inflammatory marker levels including Interleukin (IL) IL-6, IL-2, Tumor Necrosis Factor Alpha (TNF-a) and procalcitonin will be evaluated in ng/L.
- Change in systemic inflammatory marker levels [ Time Frame: Baseline, Day 30 ]Change in serum systemic inflammatory marker levels including D-dimer, high sensitivity C-reactive protein (hsCRP) and ferritin will be evaluated in mg/L.
- COVID-19 Viral Load [ Time Frame: Up to 30 Days ]Assessed using blood samples or nose/throat swabs.
- Change in SOFA score [ Time Frame: Baseline, Up to 30 Days ]Sequential Organ Failure Assessment (SOFA) will be used to assess organ failure including the cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs. SOFA score ranges from 0-24 with the higher score indicating worse outcomes.
- Change in electrolytes levels [ Time Frame: Baseline, Up to 30 Days ]Sodium, Potassium, Chloride and Carbon Dioxide (CO2) will be evaluated in mmol/L. Changes from baseline to Day 30 will be compared between groups.
- Change in LDH levels [ Time Frame: Baseline, Up to 30 Days ]Serum Lactate Dehydrogenase (LDH) levels assessed in U/L. Changes in LDH from baseline to Day 30 will be compared between groups.
- Number of subjects discharged from the ICU [ Time Frame: Up to 7 Days ]ICU monitoring status will be reported as the number of subjects discharged from the ICU within 7 days.
- Percentage of participants with less requirement for vasoactive agents [ Time Frame: Up to 30 Days ]Percentage of participants requiring less use of vasoactive agents will be reported.
- Rate of Mortality [ Time Frame: Up to 30 Days ]Percentage of participant deaths throughout the study period.
- Percentage of participants with changes in immune marker expression [ Time Frame: Up to 30 Days ]The percentage of participants with changes in serum immune marker levels including Cluster of Differentiation (CD) CD 4+ and CD 8+, as evaluated by treating physician will be reported.
- Percentage of participants with changes in radiologic findings [ Time Frame: Up to 30 Days ]Percentage of participants with changes in their chest imaging such as ground-glass opacity, local patch shadowing, bilateral patch shadowing and interstitial abnormalities will be reported. Imaging will be assessed by treating physician using chest radiography or chest Computed Tomography (CT).
- Percentage of participants with less pneumonia symptoms [ Time Frame: Up to 30 Days ]Percentage of participants showing less pneumonia symptoms will be reported as evaluated by treating physician using chest radiography or chest CT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04490486
|Contact: Joshua M Hare, MD||305-243-5579||Jhare@med.miami.edu|
|Contact: Yvenie Desire, BS||305-243-7273||Ydesire@miami.edu|
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Contact: Joshua M Hare, MD 305-243-5579 firstname.lastname@example.org|
|Principal Investigator:||Joshua M Hare, MD||ISCI/University of Miami Miller School of Medicine|