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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1277 | Drug: Standard treatment Standard treatment Wiki | 0.58 |
| drug232 | Aerosolized 13 cis retinoic acid plus Inhalation administration by nebulization captopril 25mg Wiki | 0.58 |
| drug1233 | Diphenhydramine Wiki | 0.58 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D013577 | Syndrome NIH | 0.16 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.10 |
| D055371 | Acute Lung Injury NIH | 0.10 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There are 3 clinical trials
The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with ARDS due to coronavirus infection 2019 (COVID-19).
The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS. The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.
Description: Number of all-cause mortality within 30 days of randomization.
Measure: Number of all-cause mortality Time: 30 daysDescription: Number of days alive off mechanical ventilatory support calculated as the number of days, within the 60 days window, that patients were alive and free of mechanical ventilatory support.
Measure: Number of days alive off mechanical ventilatory support Time: 60 daysDescription: Safety analyses will be assessed by adverse event rates calculated as the ratio of the total number of events over 30 days divided by total patient-time at risk for the specific event from randomization.
Measure: Number of adverse events Time: 30 daysDescription: The number and percent of patients with resolution and/or improvement of ARDS at day 7
Measure: Number of participants with resolution and/or improvement of ARDS Time: 7 daysDescription: The number and percent of patients with resolution and/or improvement of ARDS at day 14
Measure: Number of participants with resolution and/or improvement of ARDS Time: 14 daysDescription: The number and percent of patients with resolution and/or improvement of ARDS at day 21
Measure: Number of participants with resolution and/or improvement of ARDS Time: 21 daysDescription: The number and percent of patients with resolution and/or improvement of ARDS at day 30
Measure: Number of participants with resolution and/or improvement of ARDS Time: 30 daysDescription: severity of ARDS according to Berlin Criteria at days 7 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Measure: Severity of ARDS Time: baseline and 7 daysDescription: severity of ARDS according to Berlin Criteria at days 14 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Measure: Severity of ARDS Time: baseline and 14 daysDescription: severity of ARDS according to Berlin Criteria at days 21 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Measure: Severity of ARDS Time: baseline and 21 daysDescription: severity of ARDS according to Berlin Criteria at days 30 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.
Measure: Severity of ARDS Time: baseline and 30 daysDescription: Hospital length of stay
Measure: Length of stay Time: 12 monthsDescription: number of readmission
Measure: Readmissions Time: 12 monthsDescription: Change from baseline in Clinical Improvement Scale at day 7. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.
Measure: Clinical Improvement Scale Time: 7 daysDescription: Change from baseline in Clinical Improvement Scale at day 14. Full scale from 1 to 7, with higher score indicating more clinical improvement.
Measure: Clinical Improvement Scale Time: 14 daysDescription: Change from baseline in Clinical Improvement Scale at day 21. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.
Measure: Clinical Improvement Scale Time: 21 daysDescription: Change from baseline in Clinical Improvement Scale at day 30. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.
Measure: Clinical Improvement Scale Time: 30 daysDescription: Changes from baseline in plasma hs-CRP concentration at days 7
Measure: Change in plasma hs-CRP concentration Time: baseline and 7 daysDescription: Changes from baseline in plasma hs-CRP concentration at days 14
Measure: Change in plasma hs-CRP concentration Time: baseline and 14 daysDescription: Changes from baseline in plasma hs-CRP concentration at days 21
Measure: Change in plasma hs-CRP concentration Time: baseline and 21 daysDescription: Changes from baseline in serum hs-CRP concentration at days 30
Measure: Change in serum hs-CRP concentration Time: baseline and 30 daysDescription: Changes from baseline in IL-6 inflammatory marker level at 7 days
Measure: Change in IL-6 inflammatory marker level Time: baseline and 7 daysDescription: Changes from baseline in IL-6 inflammatory marker level at 14 days
Measure: Change in IL-6 inflammatory marker level Time: baseline and 14 daysDescription: Changes from baseline in IL-6 inflammatory marker level at 21 days
Measure: Change in IL-6 inflammatory marker level Time: baseline and 21 daysDescription: Changes from baseline in IL-6 inflammatory marker level at 30 days
Measure: Change in IL-6 inflammatory marker level Time: baseline and 30 daysDescription: Changes from baseline in IL-6 inflammatory marker level at 7 days
Measure: Change in IL-8 inflammatory marker level Time: baseline and 7 daysDescription: Changes from baseline in IL-6 inflammatory marker level at 21 days
Measure: Change in IL-8 inflammatory marker level Time: baseline and 21 daysDescription: Changes from baseline in IL-6 inflammatory marker level at 14 days
Measure: Change in IL-8 inflammatory marker level Time: baseline and 14 daysDescription: Changes from baseline in IL-6 inflammatory marker level at 30 days
Measure: Change in IL-8 inflammatory marker level Time: baseline and 30 daysDescription: Changes from baseline in TNF-alpha inflammatory marker level at 7 days
Measure: Change in TNF-alpha inflammatory marker level Time: baseline and 7 daysDescription: Changes from baseline in TNF-alpha inflammatory marker level at 14 days
Measure: Change in TNF-alpha inflammatory marker level Time: baseline and 14 daysDescription: Changes from baseline in TNF-alpha inflammatory marker level at 21 days
Measure: Change in TNF-alpha inflammatory marker level Time: baseline and 21 daysDescription: Changes from baseline in TNF-alpha inflammatory marker level at 30 days
Measure: Change in TNF-alpha inflammatory marker level Time: baseline and 30 daysDescription: including the presence of emphysema, COPD, asthma, pulmonary fibrosis, other pulmonary disease, and the need for respiratory support will be reported by randomization
Measure: Pulmonary symptoms Time: 6 monthsDescription: including the presence of emphysema, COPD, asthma, pulmonary fibrosis, other pulmonary disease, and the need for respiratory support will be reported by randomization
Measure: Pulmonary symptoms Time: 12 monthsThe objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with MIS-C associated with COVID-19.
Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports