CTIS2022-501352-28-00RecruitingPhase 1
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 severe community-acquired pneumonia (sCAP) - 996
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- BIOTEST AG
- Enrollment
- 569
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •Written informed consent obtained from subject or legally acceptable/authorized representative (LAR) or written investigator certification for deferred informed consent due to emergency situation, in compliance with all local legal requirements., Hospitalized, adult (= 18 years of age) subject (any gender)., Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) negative status measured by reverse transcriptase polymerase chain reaction (RT-PCR) test from a respiratory sample taken within 72 hours prior to randomization or by another rapid test from a respiratory sample taken at screening., C-reactive protein (CRP) = 70 mg/L within 24 hours prior to start of treatment with IMP., Diagnosis of active community-acquired pneumonia (CAP) before hospital-admission or within 48 hours after admission., Radiological (or other imaging technology) evidence consistent with active pneumonia must be available from routine SoC., Acute respiratory failure requiring IMV, defining sCAP, Treatment with IMP must be started between 1 and 12 hours after initiation of IMV., Subject must receive SoC treatment for sCAP according to applicable regional and global sCAP guidelines.
Exclusion Criteria
- •01) For an incapacitated subject: any indication that the subject’s presumed will would be against inclusion in the trial., 11) Hemoglobin (Hb) < 7 g/dL assessed within 24 hours prior to start of IMP treatment., 27) Participation in another interventional clinical trial (using medications and/or procedures not according to SoC of the trial site) within 30 days before screening or previous participation in this clinical trial., 28) Employee or direct relative of an employee of the CRO, the trial site, or Biotest., 03) Subjects of child bearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment., 04) Subjects on ECMO or predicted to be on ECMO at start of IMP treatment., 05) Suspected hospital-acquired pneumonia (HAP) including ventilator associated pneumonia (VAP)., 06) Diagnosis of COVID-19 with positive SARS-CoV-2 test during the last 4 weeks., 07) Subjects that required oxygen therapy due to COVID-19 in the last 6 months., 09) Severe neutropenia (neutrophil count <500/mm³) assessed within 24 hours prior to start of IMP treatment., 10) Thrombocytopenia (platelet count < 50,000/mm³) assessed within 24 hours prior to start of IMP treatment., 19) Known intolerance to proteins of human origin or known allergic reactions to any of the components of trimodulin / placebo., 08) Subjects discharged from hospital within the previous 14 days., 12) Pre-existing hemolytic disease., 13) Pre-existing thrombosis or other thromboembolic events (TEEs) (e.g., cerebrovascular accidents, transient ischemic attack, myocardial infarction, pulmonary embolism, and deep vein thrombosis) within 3 months before screening. Subjects particularly at risk for TEEs caused by other reasons than the current sCAP (e.g., history of thrombophilia, permanent immobilization, or permanent paralysis of the lower extremities)., 14) Subject on dialysis or with severe renal impairment, estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² assessed within 24 hours prior to start of IMP treatment, 15) Subject with end-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS)., 16) Pre-existing severe lung diseases concomitant to current sCAP (e.g., subjects with chronic obstructive pulmonary disease [COPD] on longterm oxygen treatment or on non-invasive ventilation [NIV], severe interstitial lung disease [incl. idiopathic pulmonary fibrosis], cystic fibrosis, active tuberculosis, chronically infected bronchiectasis, or active lung cancer)., 17) Pre-existing decompensated heart failure (New York Heart Association class III–IV)., 18) Pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh score = 9 points), or hepatocellular carcinoma., 29) Persons, subject to legal protection measures, if applicable according to local laws., 20) Selective IgA deficiency with known antibodies to IgA., 02) Pregnant or lactating women., 21) 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., 22) Morbid obesity with high body mass index (BMI) = 40 kg/m2, or malnutrition with low BMI < 16 kg/m2., 23) Treatment with polyvalent immunoglobulin preparations, plasma, or albumin preparations during the last 21 days before screening., 24) Treatment with fluoroquinolone preparations, during the last 5 days before screening., 25) Treatment with any type of in
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