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Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)

PHASE3RECRUITING

The main objective of the trial is 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 sCAP on invasive mechanical ventilation (IMV). Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.

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Study details:

This is a randomized, placebo-controlled, double-blind, multi-center, multi-national, phase III trial, to assess the efficacy and safety of trimodulin compared to placebo treatment, as adjunctive treatment to SoC in adult hospitalized subjects with sCAP receiving IMV. Subjects will be randomized on a 1:1 basis to receive trimodulin or placebo, stratified by center. Investigational medicinal product (IMP) treatments will be blinded.

Subject will be administered IMP once daily on 5 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 visit/telephone call on day 29 \[+3\]. For subjects still in the hospital (trial site) after day 29, an extended follow-up is conducted until discharge or until day 90.

For all subjects alive on day 29, a closing visit/telephone call on day 91 \[+10\] will be done.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Written informed consent.

Hospitalized, adult (≥ 18 years of age) subject.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) negative status.

Signs of inflammation based on C-reactive protein threshold level.

Diagnosis of active pneumonia.

Radiological (or other imaging technology) evidence consistent with active pneumonia.

Acute respiratory failure requiring IMV.

Exclusion criteria

For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in the trial.

Pregnant or lactating women.

Subjects not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.

Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP).

Diagnosis of COVID-19 during the last 4 weeks.

Subjects that required oxygen therapy due to COVID-19 in the last 6 months.

Defined neutrophil counts within 24 hours prior to start of IMP treatment.

Defined platelet counts within 24 hours prior to start of IMP treatment.

Defined hemoglobin within 24 hours prior to start of IMP treatment.

Known hemolytic disease.

Known thrombosis or thromboembolic events (TEEs) or known medical history of TEEs or subjects particularly at risk for TEEs.

Subject on dialysis or with severe renal impairment within 24 hours prior to start of IMP treatment.

Subject with end-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS).

Known severe lung diseases interfering with sCAP therapy (e.g., subjects with chronic obstructive pulmonary disease [COPD], severe interstitial lung disease [incl. idiopathic pulmonary fibrosis], cystic fibrosis, active tuberculosis, chronically infected bronchiectasis, or active lung cancer).

Known decompensated heart failure.

Known pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh score ≥ 9 points), or hepatocellular carcinoma.

Known intolerance to proteins of human origin or known allergic reactions to components of trimodulin / placebo.

Selective immunoglobulin A (IgA) deficiency with known antibodies to IgA.

Known treatment for thorax/head/neck/hematologic malignancies in the last 12 months before screening.

Life expectancy of less than 90 days, according to the investigator's clinical judgment, because of medical conditions related neither to sCAP nor to sCAP-associated septic conditions.

Morbid obesity with high body mass index (BMI) ≥ 40 kg/m2, or malnutrition with low BMI < 16 kg/m2.

Known treatment with polyvalent immunoglobulin preparations, plasma, or albumin preparations during the last 21 days before screening.

Known treatment with predefined medications, during the last 5 days before screening.

Any type of interferon during the last 21 days before screening.

Ongoing treatment with immunosuppressants other than guideline recommended immunosuppressants for treatment of active pneumonia.

Participation in another interventional clinical trial within 30 days before screening or previous participation in this clinical trial.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-09-09

Primary completion: 2025-02-28

Study completion finish: 2025-04-30

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05722938

Intervention or treatment

DRUG: Trimodulin

DRUG: Placebo (human albumin 1%)

Conditions

• Community-acquired Pneumonia

Image related to Community-acquired Pneumonia

Condition: Community-acquired Pneumonia
DRUG: Trimodulin and other drugs
Woolloongabba, Queensland, Australia and more
Sponsor: Biotest

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Find a site

Closest Location:

Princess Alexandra Hospital

Research sites nearby

Select from list below to view details:

Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Austin Health
Heidelberg, Not Specified, Australia
Footscray Hospital
Footscray, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Trimodulin Trimodulin (human IgM, IgA, IgG solution) for intravenous (IV) administration.	DRUG: Trimodulin IMP will be administered via IV infusion on 5 consecutive days
PLACEBO_COMPARATOR: Placebo Human albumin 1%	DRUG: Placebo (human albumin 1%) IMP will be administered via IV infusion on 5 consecutive days

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
28-day all-cause mortality rate	Percentage of subjects that died until day 29 regardless of cause of death	Between days 1-29

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
90-day all-cause mortality rate	Percentage of subjects that died until day 91 regardless of cause of death	Between days 1-91
28-day all-cause mortality rate plus day 6-29 deterioration rate	1. Percentage of subjects that died until day 29 2. Percentage of subjects with at least one deterioration event between day 6 and day 29	1. Between days 1-29; 2. Between days 6-29
Deterioration rate (day 6-29)	Percentage of subjects with at least one deterioration event between day 6 and day 29	Between days 6-29
28-day all-cause mortality rate plus day 1-29 deterioration rate	1. Percentage of subjects that died until day 29 2. Percentage of subjects with at least one deterioration event between day 1 and day 29	1.+2. Between days 1-29
Deterioration rate (day 1-29)	Percentage of subjects with at least one deterioration event between day 1 and day 29	Between days 1-29
Change in Sequential Organ Failure Assessment (SOFA) score from baseline to days 3, 5, 7, 14, 21, 29 and discharge	Change in Sequential Organ Failure Assessment (SOFA)	Between baseline and Days 3, 5, 7, 14, 21, 29 and discharge
Proportion of subjects with clinical cure of pneumonia on days 7, 14, 21, 29 and discharge	Percentage of subjects with clinical cure of pneumonia	On days 7, 14, 21, 29 or on the day of discharge
Days of invasive mechanical ventilation (IMV) until day 29	Days of invasive mechanical ventilation (IMV) until day 29	Until day 29
Ventilator-free days (VFD) until day 29	Ventilator-free days (VFD)	Until day 29
Days with oxygen supply until day 29	Days with oxygen supply	Until day 29
Proportion of subjects with oxygen supply on days 7, 14, 21, 29 and discharge	Percentage of subjects with oxygen supply	On days 7, 14, 21, 29 or on the day of discharge
Proportion of subjects with PaO2/FiO2 ratio < 100, 100 to < 200, 200 to < 300 or ≥ 300 on days 7, 14, 21, and 29	Percentage of subjects with PaO2/FiO2 ratio \< 100, 100 to \< 200, 200 to \< 300 or ≥ 300	On days 7, 14, 21, 29
Vasopressor-free days until day 29	Vasopressor-free days until day 29	Until day 29
Days in intensive care unit (ICU) until day 29	Days in intensive care unit (ICU) until day 29	Until day 29
Time to discharge from ICU	Time to discharge from ICU	Until day 91
Proportion of subjects in ICU on days 7, 14, 21 and 29	Percentage of subjects in ICU	On days 7, 14, 21, 29
Days of hospitalization until day 29	Days of hospitalization	Until day 29
Time to discharge from hospital	Time to discharge from hospital	Until day 91
Proportion of subjects in hospital on days 7, 14, 21 and 29	Percentage of subjects in hospital	On days 7, 14, 21, 29
28-day readmission rate	Percentage of subjects readmitted to the hospital	Day 29
Rate of unscheduled return(s) to the emergency department or primary physician between day 29 and day 91	Percentage of subjects returning to the emergency department or primary physician	Between Days 29 - 91
Time to return to normal activities until day 91	Time to return to normal activities	Until day 91
Health status based on Clinical Frailty Scale (CFS) on day 91	Change in Health status from Baseline assessment based on Clinical Frailty Scale (score 1 very fit to score 9 terminally ill)	Between Days 29 - 91
Quality of life based on Nottingham Health Profile (NHP) on days 29 and 91	Change in Quality of life based on Nottingham Health Profile (NHP)	Day 29 and day 91
Adverse events (AEs), treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), infusional TEAEs, TEAEs that led to permanent withdrawal of IMP and/or discontinuation of trial	Number, severity, causality, outcome, and seriousness of all AEs and TEAEs, AESIs, infusional TEAEs, TEAEs that led to permanent withdrawal of IMP, and TEAEs that led to discontinuation of the trial	Until day 29
Infusion-related TEAEs	Number of all infusion-related TEAEs	Until day 29
Serious adverse events (SAEs)	Number, severity, causality, and outcome of all SAEs	Until day 29
Dose modifications	Dose modifications (including reductions and changes in infusion rate)	Day 1-5
Change over time in electrocardiogram (ECG) parameters	ECG output (diagram including QT-interval and QTcF) showing abnormal, clinically relevant findings will be reported as adverse event	Days -1, 1, 3, 5 and once between days 8-13
Number and changes in observed Adverse Events in vital signs over time	Clinically significant changes in values of vital signs (including systolic and diastolic blood pressure, arterial oxygen saturation, heart rate, respiratory rate and body temperature) are rated as adverse events. The number of adverse events and changes in numbers of the adverse events over time will be reported	Days -1, 1-3, 5, 7, 14, 21, 29
Number and changes in observed Adverse Events in clinical laboratory parameters over time	Clinically significant changes in clinical laboratory values (including chemistry, hematology and coagulation) are rated as adverse events. The number of adverse events and changes in numbers of the adverse events over time will be reported	Days -1, 1-5, 7, 14, 21, 29

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References

Clinical Trials Gov: Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)