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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Drug: Trimodulin; Drug: Placebo (human albumin 1%)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 590
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Patrick Langohr; Phone Number: +491732947122; Email: patrick.langohr@biotest.com
• Study Contact Backup: Name: Claudia Schulte; Phone Number: +4915222801491; Email: claudia.schulte@biotest.com

Study Locations

• Argentina
  • Ciudad Autonoma de Buenos Aire, Argentina, 1431
    • Recruiting
    • CEMIC
  • Ciudad Autonoma de Buenos Aire, Argentina, C1039AAO
    • Withdrawn
    • Sanatorio de la Trinidad Mitre
  • Ciudad Autonoma de Buenos Aire, Argentina, C1181ACH
    • Withdrawn
    • Hospital Italiano de Buenos Aires
  • Ciudad Autonoma de Buenos Aire, Argentina, C1430BKC
    • Withdrawn
    • Hospital General de Agudos Dr. Ignacio Pirovano
  • Ciudad Autonoma de Buenos Aire, Argentina, C1430EGF
    • Withdrawn
    • Clinica Adventista Belgrano
  • Córdoba, Argentina, 5000
    • Recruiting
    • Hospital San Roque
  • Córdoba, Argentina, X5000BSQ
    • Withdrawn
    • Sanatorio Privado de la Canada - Cordoba
  • Córdoba, Argentina, 5000
    • Withdrawn
    • Clínica Chutro
  • Rosario, Argentina, S2001SBK
    • Withdrawn
    • Centro Medico IPAM
  • San Nicolás, Argentina, 2900
    • Recruiting
    • Estudios Clinicos de los Arroyos
  • Villa María, Argentina, 5900
    • Recruiting
    • Sanatorio de la Canada
  • Córdoba Province
    • San Vicente, Córdoba Province, Argentina, 5006
      • Withdrawn
      • Sanatorio Parque S.A. Privado
• Australia
  • Footscray, Australia, 3011
    • Recruiting
    • Footscray Hospital
  • Heidelberg, Australia, 3084
    • Recruiting
    • Austin Health
  • Saint Albans, Australia, 3021
    • Recruiting
    • Sunshine Hospital
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Withdrawn
      • Princess Alexandra Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Medical Centre
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Sir Charles Gairdner Hospital
• Austria
  • Klagenfurt, Austria, 9020
    • Withdrawn
    • KABEG-Klinikum Klagenfurt
  • Vienna, Austria, 1090
    • Withdrawn
    • AKH - Medizinische Universitat Wien
• Belgium
  • Aalst, Belgium, 9300
    • Recruiting
    • Onze Lieve Vrouw Ziekenhuis
  • Bruges, Belgium, 8000
    • Recruiting
    • AZ Sint-Jan
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-luc
  • Brussels, Belgium, 1070
    • Recruiting
    • Hopital Erasme
  • Edegem, Belgium, 2650
    • Recruiting
    • Antwerp University Hospital (UZA)
  • Genk, Belgium, 3600
    • Recruiting
    • ZOL
  • Ghent, Belgium, 9000
    • Recruiting
    • AZ Maria Middelares
  • Jette, Belgium, 1090
    • Recruiting
    • Universitair Ziekenhuis Brussel
  • Liège, Belgium, 4000
    • Recruiting
    • C. H. R. de la Citadelle
  • Lodelinsart, Belgium, 6042
    • Recruiting
    • CHU Charleroi Hôpital Civil Marie Curie
  • Ottignies, Belgium, 1340
    • Recruiting
    • Clinique Saint-Pierre
  • Roeselare, Belgium, 8800
    • Recruiting
    • AZ Delta VZW
• Brazil
  • Botucatu, Brazil, 18618-686
    • Recruiting
    • UPECLIN - Unidade de Pesquisa Clínica
  • Campinas, Brazil, 13060-904
    • Withdrawn
    • HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
  • Campo Largo, Brazil, 83606-177
    • Recruiting
    • Hospital do Rocio
  • Caxias do Sul, Brazil, 95070-560
    • Recruiting
    • Universidade de Caxias do Sul, IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos
  • Passo Fundo, Brazil, 99010-260
    • Recruiting
    • Hospital de Clinicas de Passo Fundo
  • Porto Alegre, Brazil, 90160-093
    • Recruiting
    • Hospital Ernesto Dornelles
  • Porto Alegre, Brazil, 90020-090
    • Recruiting
    • Irmandade da Santa Casa de Misericordia de Porto Alegre
  • Porto Alegre, Brazil, 90035-903
    • Withdrawn
    • Hospital De Clinicas De Porto Alegre
  • São José do Rio Preto, Brazil, 15090-000
    • Recruiting
    • CIP - Centro Integrado de Pesquisa
  • São Paulo, Brazil, 01323-020
    • Withdrawn
    • Hospital Alemao Oswaldo Cruz
  • São Paulo, Brazil, 09530-700
    • Withdrawn
    • Universidade Municipal de São Caetano do Sul (USCS)
• Czechia
  • Brno, Czechia, 65691
    • Recruiting
    • Fakultni nemocnice u sv. Anny v Brne
  • Kolín, Czechia, 28002
    • Recruiting
    • Oblastni nemocnice Kolin a.s.
  • Kyjov, Czechia, 69701
    • Recruiting
    • Hospital Kyjov
  • Prague, Czechia, 10034
    • Recruiting
    • Fakultni nemocnice Kralovske Vinohrady
• France
  • Argenteuil, France, 95107
    • Recruiting
    • Centre Hospitalier Victor Dupouy
  • Colombes, France, 92700
    • Withdrawn
    • Hôpital Louis Mourier
  • Grenoble, France, 38043
    • Recruiting
    • CHU de Grenoble - Hopital Albert Michallon
  • Lille, France, 59037
    • Withdrawn
    • CHRU Lille - Hôpital Salengro
  • Limoges, France, 87000
    • Withdrawn
    • Chu de Limoges - Hopital Dupuytren
  • Melun, France, 77000
    • Recruiting
    • Centre Hospitalier de Melun
  • Nice, France, 06202
    • Recruiting
    • CHU Nice-Hopital de l' Archet
  • Nice, France, 6100
    • Recruiting
    • CHU Nice Hopital Pasteur 2
  • Paris, France, 75679
    • Recruiting
    • Hopital Cochin
  • Paris, France, 75018
    • Recruiting
    • Hôpital Bichat - Claude Bernard
  • Paris, France, 75020
    • Recruiting
    • Hopital Tenon
  • Paris, France, 75020
    • Recruiting
    • Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon
  • Reims, France, 51100
    • Recruiting
    • CHU Reims - Hôpital Robert Debré
  • Rennes, France, 35000
    • Recruiting
    • CHU Rennes - Hôpital Pontchaillou
  • Saint-Etienne, France, 42055
    • Recruiting
    • CHU Saint-Etienne
  • Strasbourg, France, 67091
    • Recruiting
    • CHU Strasbourg - Nouvel Hopital Civil
  • Strasbourg, France, 67098
    • Withdrawn
    • CHU Strasbourg - Hôpital Hautepierre
  • Toulon, France, 83056
    • Withdrawn
    • Hôpital Sainte Musse
  • Tours, France, 37000
    • Withdrawn
    • CHU Tours - Hôpital Bretonneau
  • Trévenans, France, 90400
    • Recruiting
    • Hôpital Nord Franche-Comté
• Germany
  • Berlin, Germany, 10117
    • Withdrawn
    • Charité Universitätsmedizin Berlin - Campus Charité Mitte
  • Essen, Germany, 45147
    • Recruiting
    • Universitaetsklinikum Essen
  • Freiburg im Breisgau, Germany, 79106
    • Recruiting
    • Universitaetsklinikum Freiburg
  • Hamburg, Germany, 20246
    • Withdrawn
    • Universitatsklinikum Hamburg-Eppendorf
  • Hanover, Germany, 30625
    • Withdrawn
    • Medizinische Hochschule Hannover
• Hungary
  • Gyula, Hungary, 5700
    • Withdrawn
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  • Gyöngyös, Hungary, 3200
    • Withdrawn
    • Bugat Pal Korhaz
  • Kistarcsa, Hungary, 2143
    • Withdrawn
    • Pest Megyei Flor Ferenc Korhaz
  • Pécs, Hungary, 7624
    • Withdrawn
    • Aneszteziologiai es Intenziv Terapias Intezet
  • Szeged, Hungary, 6725
    • Withdrawn
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Székesfehérvár, Hungary, 8000
    • Recruiting
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
• Ireland
  • Dublin, Ireland, Dublin 4
    • Recruiting
    • St Vincents University Hospital
  • Dublin, Ireland, D09 V2N0
    • Recruiting
    • Beaumont Hospital
  • Dublin, Ireland, D08NYH1
    • Recruiting
    • St James's Hospital
  • Galway, Ireland, H91YR71
    • Recruiting
    • University Hospital Galway
• Israel
  • Beersheba, Israel, 8410101
    • Recruiting
    • Soroka Medical Center
  • Haifa, Israel, 31096
    • Recruiting
    • Rambam Medical Center
  • Haifa, Israel, 31048
    • Recruiting
    • Bnai Zion Medical Center
  • Haifa, Israel, 3436212
    • Recruiting
    • The Lady Davis Carmel Medical Center
  • Petah Tikva, Israel, 4941492
    • Recruiting
    • Rabin Medical Center
  • Rehovot, Israel, 761001
    • Recruiting
    • Kaplan Medical Center
  • Tel Aviv, Israel, 64239
    • Recruiting
    • Tel Aviv Sourasky Medical Center
• New Zealand
  • Otahuhu, New Zealand, 2025
    • Recruiting
    • Middlemore Hospital
  • Wellington, New Zealand, 6021
    • Recruiting
    • Capital, Coast and Hutt Valley District - Wellington Regional Hospital
• Philippines
  • Baguio City, Philippines, 2600
    • Recruiting
    • Baguio General Hospital and Medical Center
  • Caloocan, Philippines, 1427
    • Recruiting
    • Dr. Jose N. Rodriguez Memorial Hospital
  • Davao City, Philippines, 8000
    • Recruiting
    • Southern Philippines Medical Center
  • Davao City, Philippines, 8000
    • Withdrawn
    • Davao Doctors Hospital
  • Iloilo City, Philippines, 5000
    • Recruiting
    • West Visayas State University Medical Center
  • Iloilo City, Philippines, 5000
    • Withdrawn
    • St.Paul's Hospital
  • Manila, Philippines, 1000
    • Recruiting
    • Philippine General Hospital
  • Quezon City, Philippines, 1100
    • Recruiting
    • Lung Center Of The Philippines
• Romania
  • Bucharest, Romania, 050098
    • Recruiting
    • Spitalul Universitar de Urgenta Bucuresti
  • Bucharest, Romania, 022328
    • Withdrawn
    • Institutul Clinic Fundeni
  • Timișoara, Romania, 300723
    • Recruiting
    • Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"
• South Africa
  • Johannesburg, South Africa, 1500
    • Withdrawn
    • Worthwhile Clinical Trials
  • Pretoria, South Africa, 0002
    • Withdrawn
    • RYEXO Clinical Research Zuid Afrikaans Hospital
  • Pretoria, South Africa, 0184
    • Terminated
    • Ryexo Clinical Research
  • Somerset West, South Africa, 7130
    • Recruiting
    • Dr JM Engelbrecht Trial Site
  • Gauteng
    • Centurion, Gauteng, South Africa, 0157
      • Recruiting
      • Johese Clinical Research
    • Pretoria, Gauteng, South Africa, 0002
      • Withdrawn
      • EMMED Clinical Research
    • Pretoria, Gauteng, South Africa, 0181
      • Withdrawn
      • Into Research
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 8035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital de la Santa Creu i de Sant Pau
  • Barcelona, Spain, 8907
    • Recruiting
    • Hospital Universitari de Bellvitge
  • Córdoba, Spain, 14004
    • Recruiting
    • Hospital Universitario Reina Sofia
  • Girona, Spain, 17007
    • Recruiting
    • Hospital Universitari de Girona Dr Josep Trueta
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Clínico San Carlos
  • Madrid, Spain, 28046
    • Withdrawn
    • Hospital Universitario La Paz
  • Majadahonda, Spain, 28222
    • Withdrawn
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Palma de Mallorca, Spain, 07120
    • Recruiting
    • Hospital Universitario Son Espases
  • Pamplona, Spain, 31008
    • Recruiting
    • Clinica Universidad de Navarra
  • Tarragona, Spain, 43007
    • Recruiting
    • Hospital Universitari de Tarragona Joan XXIII
  • Terrassa, Spain, 8221
    • Recruiting
    • Hospital Universitari Mutua de Terrassa
  • Valencia, Spain, 46026
    • Withdrawn
    • Hospital Universitari i Politecnic La Fe
• United Kingdom
  • Glasgow, United Kingdom, G11 6NT
    • Recruiting
    • Queen Elizabeth University Campus
  • Guildford, United Kingdom, GU2 7XX
    • Withdrawn
    • Royal Surrey County Hospital
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • King's College Hospital
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • St Thomas' Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Recruiting
    • Derriford Hospital
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Withdrawn
      • Pulmonary Associates of Mobile, P.C.
  • California
    • Fresno, California, United States, 93701
      • Recruiting
      • University of California San Francisco-Fresno
    • Sacramento, California, United States, 95817
      • Withdrawn
      • UC Davis Health
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Withdrawn
      • Augusta University
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Withdrawn
      • Sparrow Clinical Research Institute
    • Royal Oak, Michigan, United States, 48073
      • Withdrawn
      • William Beaumont Hospital
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Withdrawn
      • University of Missouri Clinical Research Center
    • Hannibal, Missouri, United States, 63401
      • Withdrawn
      • Hannibal Clinic
  • Montana
    • Butte, Montana, United States, 59701
      • Withdrawn
      • Mercury Street Medical Group
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • Withdrawn
      • St. Michael's Medical Center
  • New York
    • Buffalo, New York, United States, 14215
      • Withdrawn
      • Buffalo VA Medical Center
    • New York, New York, United States, 10075-1850
      • Recruiting
      • Lenox Hill Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Baptist
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Withdrawn
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Withdrawn
      • Jefferson University Hospitals
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Withdrawn
      • Vanderbilt University Medical Center
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Withdrawn
      • Medical City Fort Worth
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Recruiting
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria:

1. Written informed consent.
2. Hospitalized, adult (≥ 18 years of age) subject.
3. Signs of inflammation based on C-reactive protein threshold level.
4. Diagnosis of active community-acquired pneumonia (CAP) before hospital-admission or within 48 hours after admission.
5. Radiological (or other imaging technology) evidence consistent with active pneumonia.
6. Acute respiratory failure requiring IMV.

Main Exclusion Criteria:

1. For an incapacitated subject: any indication that the subject's presumed will would be against inclusion in the trial.
2. Pregnant or lactating women.
3. Subjects of childbearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.
4. Subjects on ECMO at start of IMP treatment.
5. Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP).
6. Subjects discharged from hospital within the previous 14 days.
7. Defined neutrophil counts up to one calendar day prior to start of IMP treatment.
8. Defined platelet counts up to one calendar day prior to start of IMP treatment.
9. Defined hemoglobin within up to one calendar day prior to start of IMP treatment.
10. Pre-existing hemolytic disease.
11. Thromboembolic events (TEEs) caused by other reasons than the current sCAP within 3 months before start of IMP treatment unless the risk for further TEEs can be adequately managed with standard prophylaxis or treatment.
12. Severe renal impairment prior to start of IMP treatment.
13. End-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS).
14. Pre-existing severe lung diseases concomitant to current sCAP (e.g. active tuberculosis, active lung cancer).
15. Pre-existing decompensated heart failure.
16. Pre-existing severe hepatic cirrhosis (Child Pugh score ≥ 10 points), or severe hepatic impairment (Child Pugh score ≥ 10 points), or hepatocellular carcinoma.
17. Known intolerance to proteins of human origin or known allergic reactions to components of trimodulin / placebo.
18. Selective immunoglobulin A (IgA) deficiency with known antibodies to IgA.
19. 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.
20. Morbid obesity with high body mass index (BMI) ≥ 40 kg/m2, or malnutrition with low BMI < 16 kg/m2.
21. Treatment with polyvalent immunoglobulin preparations during the last 21 days before start of IMP treatment.
22. Known treatment with predefined medications, during the last 2 days before start of IMP treatment.
23. Hematopoietic stem cell transplantation or previous lung transplantation.
24. Treatment with investigational medications/procedures not according to SoC of the trial site, due to participation in another interventional clinical trial within 30 days before start of IMP treatment, or previous treatment with IMP in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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; Other Names: BT588
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 Measures

Outcome Measure	Measure Description	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 Measures

Outcome Measure	Measure Description	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
Ventilator-free days (VFD) until day 29	Ventilator-free days (VFD)	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
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
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
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 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
Deterioration rate (up to day 29)	Percentage of subjects with at least one deterioration event up to day 29	Up to day 29
Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7	Change in Sequential Organ Failure Assessment (SOFA)	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	Up to day 29
Days of invasive mechanical ventilation (IMV) up to day 29	Days of invasive mechanical ventilation (IMV) up to day 29	Up to day 29
Days with oxygen supply up to day 29	Days with oxygen supply	Up to day 29
Proportion of subjects with oxygen supply on days 7, 14, 21 and 29	Percentage of subjects with oxygen supply	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	Up to day 29
Days of hospitalization up to day 29	Days of hospitalization	Up to day 29
Time to return to normal activities up to day 91	Time to return to normal activities	Up to day 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	Up to day 29
Infusion-related TEAEs	Number of all infusion-related TEAEs	Up to day 91
Serious adverse events (SAEs)	Number, severity, causality, and outcome of all SAEs	Up to day 29
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, 1-5, 7, 14, 21, 29

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration of immunoglobulins	Changes of serum concentration of IgM, IgA, and IgG from baseline, during and after treatment	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	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)	Day 1, 2, 3, 4, 5, 7, 14, 21, 29

Collaborators and Investigators

• Sponsor: Biotest
• Investigators: Principal Investigator: Ricard Ferrer Roca, Dr., Hospital Vall d'Hebron

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2023
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Severe Community-acquired Pneumonia
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Pneumonia; Community-Acquired Infections; Community-Acquired Pneumonia; trimodulin
• Other Study ID Numbers: 996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No