CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


UCMSCsWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug319 Azithromycin Capsule Wiki 1.00
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (7)


Name (Synonyms) Correlation
D007249 Inflammation NIH 0.19
D055371 Acute Lung Injury NIH 0.10
D012127 Respiratory Distress Syndrome, Newborn NIH 0.09
D012128 Respiratory Distress Syndrome, Adult NIH 0.08
D011014 Pneumonia NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.06

There is one clinical trial.

Clinical Trials


1 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

The purpose of this study is to demonstrate the safety of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UCMSCs) administered intravenously in patients with acute pulmonary inflammation due to COVID-19 with moderately severe symptoms

NCT04490486 COVID-19 Acute Respiratory Distress Syndrome Corona Virus Infection Biological: UCMSCs Other: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Pneumonia Inflammation
HPO:Pneumonia

Primary Outcomes

Description: Safety of UCMSCs will be reported as the percentage of participants in each treatment group that experienced a treatment related SAEs.

Measure: Percent of participants with treatment related Serious Adverse Events (SAE)

Time: 12 months

Secondary Outcomes

Description: 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.

Measure: Change in inflammatory marker levels

Time: Baseline, Day 30

Description: Change in serum systemic inflammatory marker levels including D-dimer, high sensitivity C-reactive protein (hsCRP) and ferritin will be evaluated in mg/L.

Measure: Change in systemic inflammatory marker levels

Time: Baseline, Day 30

Description: Assessed using blood samples or nose/throat swabs.

Measure: COVID-19 Viral Load

Time: Up to 30 Days

Description: 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.

Measure: Change in SOFA score

Time: Baseline, Up to 30 Days

Description: Sodium, Potassium, Chloride and Carbon Dioxide (CO2) will be evaluated in mmol/L. Changes from baseline to Day 30 will be compared between groups.

Measure: Change in electrolytes levels

Time: Baseline, Up to 30 Days

Description: Serum Lactate Dehydrogenase (LDH) levels assessed in U/L. Changes in LDH from baseline to Day 30 will be compared between groups.

Measure: Change in LDH levels

Time: Baseline, Up to 30 Days

Description: ICU monitoring status will be reported as the number of subjects discharged from the ICU within 7 days.

Measure: Number of subjects discharged from the ICU

Time: Up to 7 Days

Description: Percentage of participants requiring less use of vasoactive agents will be reported.

Measure: Percentage of participants with less requirement for vasoactive agents

Time: Up to 30 Days

Description: Percentage of participant deaths throughout the study period.

Measure: Rate of Mortality

Time: Up to 30 Days

Description: 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.

Measure: Percentage of participants with changes in immune marker expression

Time: Up to 30 Days

Description: 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).

Measure: Percentage of participants with changes in radiologic findings

Time: Up to 30 Days

Description: Percentage of participants showing less pneumonia symptoms will be reported as evaluated by treating physician using chest radiography or chest CT.

Measure: Percentage of participants with less pneumonia symptoms

Time: Up to 30 Days


Related HPO nodes (Using clinical trials)