Ignite Creation Date:
2024-05-06 @ 6:04 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05531149
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2022-08-26
Brief Title:
Efficacy and Safety of Trimodulin BT588 in Subjects With CAP Including COVID-19 Pneumonia
Sponsor:
Biotest
Organization:
Biotest
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRICOVID
Brief Summary:
The main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care SoC compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired pneumonia CAP or moderate severe Coronavirus Disease 2019 COVID-19 pneumonia
Other objectives are to determine pharmacokinetic PK and pharmacodynamic PD properties of trimodulin
Other objectives are to determine pharmacokinetic PK and pharmacodynamic PD properties of trimodulin
Detailed Description:
This is a randomized placebo-controlled double-blind multi-center phase III trial to assess the efficacy and safety of trimodulin compared to placebo treatment adjunctive to SoC in adult hospitalized subjects with non-severe community-acquired pneumonia CAP or moderate severe Coronavirus Disease 2019 COVID-19 pneumonia Patients requiring low-flow oxygen non-invasive ventilation or high-flow oxygen and with signs of early systemic inflammation defined by C reactive protein CRP D-dimer and platelet levels will be enrolled
Subjects will be randomized to receive either trimodulin or placebo on a 11 basis stratified by type of oxygen supply before randomization and by region Investigational Medicinal Product IMP treatments will be blinded Subjects will be administered IMP once daily on five consecutive days day 1 through day 5 adjunctive to SoC The subsequent follow-up phase comprises maximally 23 days day 6 through day 28 followed by an end-of-follow-up visittelephone call on day 29 3 For all subjects still in the hospital after day 29 an extended follow-up visit is conducted until day 90 or until discharge For all subjects a closing visittelephone call on day 91 10 will be done
For the evaluation of the primary and several secondary endpoints of the trial a 9-category ordinal scale will be used The primary objective is to assess efficacy of trimodulin based on clinical deterioration and mortality to demonstrate superiority to treatment with placebo Secondary objectives are to assess efficacy and safety and to determine PK and PD properties of trimodulin compared to placebo
Subjects will be randomized to receive either trimodulin or placebo on a 11 basis stratified by type of oxygen supply before randomization and by region Investigational Medicinal Product IMP treatments will be blinded Subjects will be administered IMP once daily on five consecutive days day 1 through day 5 adjunctive to SoC The subsequent follow-up phase comprises maximally 23 days day 6 through day 28 followed by an end-of-follow-up visittelephone call on day 29 3 For all subjects still in the hospital after day 29 an extended follow-up visit is conducted until day 90 or until discharge For all subjects a closing visittelephone call on day 91 10 will be done
For the evaluation of the primary and several secondary endpoints of the trial a 9-category ordinal scale will be used The primary objective is to assess efficacy of trimodulin based on clinical deterioration and mortality to demonstrate superiority to treatment with placebo Secondary objectives are to assess efficacy and safety and to determine PK and PD properties of trimodulin compared to placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None