A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with CAP including COVID-19 pneumonia.

Conditions

Non-severe community-acquired pneumonia (CAP) or moderate or severe Coronavirus Disease 2019 (COVID-19)

Brief summary

Composite primary endpoint: Deterioration / mortality rate

Detailed description

Secondary efficacy endpoints: • Clinical deterioration rate (day 6-29) • Clinical deterioration rate (day 1-29) • 28-days all-cause mortality rate on day 29 • 90-days all-cause mortality rate on day 91 • Time to recovery to score ≤ 2 until day 29 • Proportion of subjects with score ≤ 2 on day 29 •Proportion of subjects improved, unchanged, and deteriorated/died compared to baseline at several days, Secondary safety endpoints: • Number, severity, causality, outcome, and seriousness of all adverse events (AEs), treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), infusional TEAEs, TEAEs that led to permanent withdrawal of IMP, and TEAEs that led to discontinuation of the trial through day 29 [+3] • Number of all related TEAEs through day 29 [+3], Secondary PK endpoints: Changes from baseline, during and after treatment: - Serum concentration of IgM, IgA, and IgG, Secondary PD endpoints: Changes from baseline, during and after treatment: - Factors and markers of coagulation - Markers of inflammation - Complement factors - Biomarkers - Anti-SARS-CoV-2 and anti-S. pneumoniae titers

Related papers

No related papers found yet.

Interventions

DRUGPlacebo is a solution for infusion of human albumin 1%

DRUGis an albumin preparation manufactured by dilution from the drug product of Albiomin 20%

DRUGit will be administrated via intravenous infusion.

DRUGTrimodulin (human IgM

DRUGIgA

DRUGIgG solution)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Composite primary endpoint: Deterioration / mortality rate	—

Secondary

Measure	Time frame
Secondary efficacy endpoints: • Clinical deterioration rate (day 6-29) • Clinical deterioration rate (day 1-29) • 28-days all-cause mortality rate on day 29 • 90-days all-cause mortality rate on day 91 • Time to recovery to score ≤ 2 until day 29 • Proportion of subjects with score ≤ 2 on day 29 •Proportion of subjects improved, unchanged, and deteriorated/died compared to baseline at several days, Secondary safety endpoints: • Number, severity, causality, outcome, and seriousness of all adverse events (AEs), treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), infusional TEAEs, TEAEs that led to permanent withdrawal of IMP, and TEAEs that led to discontinuation of the trial through day 29 [+3] • Number of all related TEAEs through day 29 [+3], Secondary PK endpoints: Changes from baseline, during and after treatment: - Serum concentration of IgM, IgA, and IgG, Secondary PD endpoints: Changes from baseline, during and after treatment: - Factors and markers of coagulation -	—

Measure

Time frame

Secondary efficacy endpoints: • Clinical deterioration rate (day 6-29) • Clinical deterioration rate (day 1-29) • 28-days all-cause mortality rate on day 29 • 90-days all-cause mortality rate on day 91 • Time to recovery to score ≤ 2 until day 29 • Proportion of subjects with score ≤ 2 on day 29 •Proportion of subjects improved, unchanged, and deteriorated/died compared to baseline at several days, Secondary safety endpoints: • Number, severity, causality, outcome, and seriousness of all adverse events (AEs), treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), infusional TEAEs, TEAEs that led to permanent withdrawal of IMP, and TEAEs that led to discontinuation of the trial through day 29 [+3] • Number of all related TEAEs through day 29 [+3], Secondary PK endpoints: Changes from baseline, during and after treatment: - Serum concentration of IgM, IgA, and IgG, Secondary PD endpoints: Changes from baseline, during and after treatment: - Factors and markers of coagulation -

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Countries

Austria, Belgium, France, Germany, Hungary, Latvia, Lithuania, Portugal, Slovakia

Outcome results

None listed