Respiratory tract infection
Conditions
Brief summary
The primary endpoint, named Survival and Recovery Trajectory, will be a composite of 90-day all-cause mortality and, among survivors, a daily ordinal scale analyzed as a trajectory of illness and recovery to 28 days., This hierarchical ordinal scale is a composite of: • Landmark mortality at Day 90 post-randomization • Among Day-90 survivors, their daily respiratory support level as defined by position on a five-category ordinal scale: • Hospitalized on ECMO or invasive mechanical ventilation. • Hospitalized on non-invasive ventilation or high-flow oxygen. • Hospitalized on low-intensity oxygen. • Hospitalized, no oxygen. • Discharged from index hospitalization
Detailed description
The generic key secondary endpoints for the trial are: • Hospital length-of-stay • Mortality censored at 90 days, Domain-specific secondary outcomes (during the index hospitalization, censored 90 days after enrolment)
Interventions
DRUGTOCILIZUMAB
DRUGMOXIFLOXACIN
DRUGCLARITHROMYCIN
DRUGCEFTRIAXONE
DRUGBARICITINIB
DRUGDEXAMETHASONE
DRUGROXITHROMYCIN
DRUGHYDROCORTISONE
DRUGLEVOFLOXACIN
DRUGAZITHROMYCIN
DRUGIMATINIB
DRUGERYTHROMYCIN
DRUGOSELTAMIVIR
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint, named Survival and Recovery Trajectory, will be a composite of 90-day all-cause mortality and, among survivors, a daily ordinal scale analyzed as a trajectory of illness and recovery to 28 days., This hierarchical ordinal scale is a composite of: • Landmark mortality at Day 90 post-randomization • Among Day-90 survivors, their daily respiratory support level as defined by position on a five-category ordinal scale: • Hospitalized on ECMO or invasive mechanical ventilation. • Hospitalized on non-invasive ventilation or high-flow oxygen. • Hospitalized on low-intensity oxygen. • Hospitalized, no oxygen. • Discharged from index hospitalization | — |
Secondary
| Measure | Time frame |
|---|---|
| The generic key secondary endpoints for the trial are: • Hospital length-of-stay • Mortality censored at 90 days, Domain-specific secondary outcomes (during the index hospitalization, censored 90 days after enrolment) | — |
Countries
Belgium, Croatia, Czechia, Estonia, France, Germany, Ireland, Italy, Netherlands, Portugal, Romania, Slovenia, Spain
Outcome results
None listed