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Razuprotafib Subcutaneous SolutionWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug2142 Placebo Subcutaneous Solution Wiki 1.00
drug333 BCG Wiki 1.00
drug2122 Placebo Wiki 0.05

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

1 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose Escalation and Proof-of-Concept Study to Evaluate the Safety and Efficacy of Razuprotafib in Hospitalized Subjects With Moderate to Severe Coronavirus Disease 2019 (COVID-19) (RESCUE Study)

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.

NCT04511650 COVID-19 Acute Respiratory Distress Syndrome Drug: Razuprotafib Subcutaneous Solution Drug: Placebo Subcutaneous Solution
MeSH:Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

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)