A Phase 3 interventional study of Trimodulin and Placebo (human albumin 1%) in Community-acquired Pneumonia, sponsored by Biotest. Recruiting at 170 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Biotest (part of Grifols) · Phase 3, Interventional, and Treatment
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 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.
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 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.
324 studies on the registry are indexed under Community-Acquired Pneumonia; 77 are open to participants now.
This study's planned enrollment of 590 is above the median of 250 across 195 interventional studies indexed under Community-Acquired Pneumonia.
Browse Community-Acquired Pneumonia studies →Biotest is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
First submitted after Biotest became part of Grifols.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Trimodulin (human IgM, IgA, IgG solution) for intravenous (IV) administration.
Drug: Trimodulin
Human albumin 1%
Drug: Placebo (human albumin 1%)
IMP will be administered via IV infusion on 5 consecutive days
Also known as: BT588
IMP will be administered via IV infusion on 5 consecutive days
28-day all-cause mortality rate
Percentage of subjects that died until day 29 regardless of cause of death
Time frame: Between days 1-29
90-day all-cause mortality rate
Percentage of subjects that died until day 91 regardless of cause of death
Time frame: Between days 1-91
Deterioration rate (up to day 29)
Percentage of subjects with at least one deterioration event up to day 29
Time frame: Up to day 29
Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7
Change in Sequential Organ Failure Assessment (SOFA)
Time frame: Between baseline and Day 7
Proportion of subjects with clinical cure of pneumonia up to day 29
Percentage of subjects with clinical cure of pneumonia
Time frame: Up to day 29
Days of invasive mechanical ventilation (IMV) up to day 29
Days of invasive mechanical ventilation (IMV) up to day 29
Time frame: Up to day 29
Ventilator-free days (VFD) until day 29
Ventilator-free days (VFD)
Time frame: Until day 29
Days with oxygen supply up to day 29
Days with oxygen supply
Time frame: Up to day 29
Proportion of subjects with oxygen supply on days 7, 14, 21 and 29
Percentage of subjects with oxygen supply
Time frame: On days 7, 14, 21 and 29
Days in intensive care unit (ICU) up to day 29
Days in intensive care unit (ICU) up to day 29
Time frame: Up to day 29
Time to discharge from ICU
Time to discharge from ICU
Time frame: Until day 91
Proportion of subjects in ICU on days 7, 14, 21 and 29
Percentage of subjects in ICU
Time frame: On days 7, 14, 21, 29
Days of hospitalization up to day 29
Days of hospitalization
Time frame: Up to day 29
Time to discharge from hospital
Time to discharge from hospital
Time frame: Until day 91
Proportion of subjects in hospital on days 7, 14, 21 and 29
Percentage of subjects in hospital
Time frame: On days 7, 14, 21, 29
28-day readmission rate
Percentage of subjects readmitted to the hospital
Time frame: 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
Time frame: Between Days 29 - 91
Time to return to normal activities up to day 91
Time to return to normal activities
Time frame: Up to 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)
Time frame: Between Days 29 - 91
Adverse events (AEs), treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), infusional TEAEs, TEAEs that led to permanent discontinuation 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 discontinuation of IMP, and TEAEs that led to discontinuation of the trial
Time frame: Up to day 29
Infusion-related TEAEs
Number of all infusion-related TEAEs
Time frame: Up to day 91
Serious adverse events (SAEs)
Number, severity, causality, and outcome of all SAEs
Time frame: Up to day 29
Dose modifications
Dose modifications (including reductions and changes in infusion rate)
Time frame: 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
Time frame: 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
Time frame: Days -1, 1-5, 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
Time frame: Days -1, 1-5, 7, 14, 21, 29
Serum concentration of immunoglobulins
Changes of serum concentration of IgM, IgA, and IgG from baseline, during and after treatment
Time frame: Day 1, 5, 14
Pharmacokinetic assessment of immunoglobulins
Assessment of changes in serum concentrations (g/L) of IgM, IgA, and IgG before, during and after treatment
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 9, 14, 21, 29
Pharmacodynamic assessment of disease related serum proteins
Assessment of relative changes in serum concentrations from baseline, during and after treatment of factors and markers of coagulation (e.g. % change in D-dimer), markers of inflammation (e.g. % change in CRP), complement factors (e.g. % change in C3, C4), specific antibody titers against sCAP-related pathogens (e.g. % change in Streptococcus pneumoniae antibody titers)
Time frame: Day 1, 2, 3, 4, 5, 7, 14, 21, 29
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Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Jul 2028, 58 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Trimodulin
Community-Acquired Pneumonia →