Acute Respiratory Distress Syndrome (ARDS) Due to Pneumonia or other Infections
Conditions
Brief summary
All-cause mortality at Day 28 between treatment groups
Detailed description
Efficacy: Ventilator-free days through Day 28 between treatment groups, Efficacy: All-cause mortality at Day 60 between treatment groups, Efficacy: Proportion of surviving subjects without respiratory support at Day 28 between treatment groups, Efficacy: Time to death and proportions of subjects dying over time (Days 7, 14, and 28) between treatment groups, Efficacy: Proportion of surviving subjects without respiratory support over time (Days 7, 14, and 28) between treatment groups, Efficacy: Time to discontinuation of respiratory support and proportions without respiratory support over time (Days 7, 14, and 28) between treatment groups, Efficacy: For subjects not intubated at entry, the frequency of intubation through Day 28 between treatment groups, Efficacy: To evaluate the days in the ICU and in the hospital through Day 28 between treatment groups, Efficacy: Frequency of RRT through Day 28 between treatment groups, Safety: Incidence, causality, and severity of SAEs and AEs (graded according to the NCI CTCAE version 5.0 [or higher]) in rhu-pGSN vs placebo groups, Safety: New or worsening clinically significant laboratory abnormalities in rhu-pGSN vs placebo groups
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at Day 28 between treatment groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Ventilator-free days through Day 28 between treatment groups, Efficacy: All-cause mortality at Day 60 between treatment groups, Efficacy: Proportion of surviving subjects without respiratory support at Day 28 between treatment groups, Efficacy: Time to death and proportions of subjects dying over time (Days 7, 14, and 28) between treatment groups, Efficacy: Proportion of surviving subjects without respiratory support over time (Days 7, 14, and 28) between treatment groups, Efficacy: Time to discontinuation of respiratory support and proportions without respiratory support over time (Days 7, 14, and 28) between treatment groups, Efficacy: For subjects not intubated at entry, the frequency of intubation through Day 28 between treatment groups, Efficacy: To evaluate the days in the ICU and in the hospital through Day 28 between treatment groups, Efficacy: Frequency of RRT through Day 28 between treatment groups, Safety: Incidence, causality, and severity of SAEs and AEs (graded | — |
Countries
Belgium, Bulgaria, Czechia, France, Germany, Hungary, Italy, Netherlands, Romania, Spain