Covid 19 Research using Clinical Trials (Home Page)
Placebo Subcutaneous SolutionWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (3)
Correlated MeSH Terms (4)
|
Name (Synonyms) |
Correlation |
D055371 | Acute Lung Injury NIH | 0.10 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.09 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.08 |
D018352 | Coronavirus Infections NIH | 0.04 |
Correlated HPO Terms (0)
|
Name (Synonyms) |
Correlation |
There is one clinical trial.
Clinical Trials
This is a Phase 1, randomized, double-blind, placebo-controlled, parallel-group, multicenter,
dose escalation and proof of concept study to evaluate the safety and efficacy of
razuprotafib subcutaneously administered three times daily (TID) in hospitalized subjects
with moderate to severe COVID-19. Part 1 of the study is a 2-step dose escalation period
conducted in approximately 60 subjects. Part 2 is a safety and efficacy period evaluating
razuprotafib doses selected from Part 1 and will be conducted in approximately 120 subjects.
Subjects will receive razuprotafib or placebo TID for 7 days or until discharge from the
hospital (or death) and will be evaluated for safety and efficacy through Day 28. The effects
of razuprotafib on biomarkers of coagulation, inflammation and vascular leakage will also be
evaluated.
Primary Outcomes
Measure: Number of participants with any serious adverse event from baseline to Day 7 Time: Baseline up to Day 7
Measure: Number of participants with any serious adverse event from baseline to Day 28 Time: Baseline up to Day 28
Measure: Number of participants with any treatment emergent adverse event from baseline to Day 7 Time: Baseline up to Day 7
Measure: Number of participants with any treatment emergent adverse event from baseline to Day 28 Time: Baseline up to Day 28
Secondary Outcomes
Measure: Proportion of subjects alive and free of respiratory failure at Day 7 Time: Baseline up to Day 7
Measure: Proportion of subjects alive and free of respiratory failure at Day 28 Time: Baseline up to Day 28
Measure: Length hospitalized and free of respiratory failure from baseline to Day 7 Time: Baseline up to Day 7
Measure: Length hospitalized and free of respiratory failure from baseline to Day 28 Time: Baseline up to Day 28
Measure: Length of hospitalization from baseline to Day 7 Time: Baseline up to Day 7
Measure: Length of hospitalization from baseline to Day 28 Time: Baseline up to Day 28
Measure: Proportion of subjects who improve by at least 2 categories on the NIAID 8-point ordinal scale from baseline to Day 7 Time: Baseline up to Day 7
Measure: Proportion of subjects who improve by at least 2 categories on the NIAID 8-point ordinal scale from baseline to Day 28 Time: Baseline up to Day 28
Measure: Proportion of subjects who worsen by at least 2 categories on the NIAID 8-point ordinal scale from baseline to Day 7 Time: Baseline up to Day 7
Measure: Proportion of subjects who worsen by at least 2 categories on the NIAID 8-point ordinal scale from baseline to Day 28 Time: Baseline up to Day 28
Measure: All-cause mortality at Day 7 Time: Baseline up to Day 7
Measure: All-cause mortality at Day 28 Time: Baseline up to Day 28
Measure: Length of ICU stay from baseline to Day 28 Time: Baseline up to Day 28
Measure: Number of subjects in each category of the NIAID 8-point ordinal scale at Day 7 Time: Baseline up to Day 7
Measure: Number of subjects in each category of the NIAID 8-point ordinal scale at Day 28 Time: Baseline up to Day 28
Measure: Time to return to prehospitalization oxygen requirement Time: Baseline up to Day 28
Measure: Proportion of subjects who were discharged and remained free of respiratory failure prior to Day 7 Time: Baseline up to Day 7
Measure: Proportion of subjects who were discharged and remained free of respiratory failure prior to Day 28 Time: Baseline up to Day 28
Measure: Change in PaO2:FiO2 ratio from baseline to Day 7 Time: Baseline up to Day 7
Measure: Change in PaO2:FiO2 ratio from baseline to Day 28 Time: Baseline up to Day 28
Other Outcomes
Measure: Change from baseline in systemic biomarkers of vascular leakage and inflammation (ie, Angpt 2, IL-6, IL-8, TNFα, HMGB-1, CRP and D-dimer); Time: Baseline up to Day 7
No related HPO nodes (Using clinical trials)