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

NCT05722938 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 996
• Study Type: interventional
• Target: 590
• Locations: 17 countries
• Sites: 140

Brief Summary

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.

Conditions

Community-acquired Pneumonia

Keywords

Severe Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality rate

  Percentage of subjects that died until day 29 regardless of cause of death

  Between days 1-29

Secondary Outcomes (25)

• 90-day all-cause mortality rate

  Between days 1-91

• Deterioration rate (up to day 29)

  Up to day 29

• Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7

  Between baseline and Day 7

• Proportion of subjects with clinical cure of pneumonia up to day 29

  Up to day 29

• Days of invasive mechanical ventilation (IMV) up to day 29

  Up to day 29

Other Outcomes (3)

• Serum concentration of immunoglobulins

  Day 1, 5, 14

• Pharmacokinetic assessment of immunoglobulins

  Day 1, 2, 3, 4, 5, 6, 7, 9, 14, 21, 29

• Pharmacodynamic assessment of disease related serum proteins

  Day 1, 2, 3, 4, 5, 7, 14, 21, 29

Study Arms (2)

Trimodulin

EXPERIMENTAL

Trimodulin (human IgM, IgA, IgG solution) for intravenous (IV) administration.

Drug: Trimodulin

Placebo

PLACEBO COMPARATOR

Human albumin 1%

Drug: Placebo (human albumin 1%)

Interventions

Trimodulin DRUG

IMP will be administered via IV infusion on 5 consecutive days

Also known as: BT588

Trimodulin

Placebo (human albumin 1%) DRUG

IMP will be administered via IV infusion on 5 consecutive days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Hospitalized, adult (≥ 18 years of age) subject.
• Signs of inflammation based on C-reactive protein threshold level.
• 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.
• Acute respiratory failure requiring IMV.

You may not qualify if:

• Pregnant or lactating women.
• Subjects of childbearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.
• Subjects on ECMO at start of IMP treatment.
• Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP).
• Subjects discharged from hospital within the previous 14 days.
• Defined neutrophil counts up to one calendar day prior to start of IMP treatment.
• Defined platelet counts up to one calendar day prior to start of IMP treatment.
• Defined hemoglobin within up to one calendar day prior to start of IMP treatment.
• Pre-existing hemolytic disease.
• 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.
• Severe renal impairment prior to start of IMP treatment.
• End-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS).
• Pre-existing severe lung diseases concomitant to current sCAP (e.g. active tuberculosis, active lung cancer).
• Pre-existing decompensated heart failure.
• Pre-existing severe hepatic cirrhosis (Child Pugh score ≥ 10 points), or severe hepatic impairment (Child Pugh score ≥ 10 points), or hepatocellular carcinoma.

Sponsors & Collaborators

• Biotest: lead

Study Sites (146)

Pulmonary Associates of Mobile, P.C.

Mobile, Alabama, 36608, United States

WITHDRAWN

University of California San Francisco-Fresno

Fresno, California, 93701, United States

RECRUITING

UC Davis Health

Sacramento, California, 95817, United States

WITHDRAWN

Augusta University

Augusta, Georgia, 30912, United States

WITHDRAWN

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

WITHDRAWN

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

WITHDRAWN

University of Missouri Clinical Research Center

Columbia, Missouri, 65212, United States

WITHDRAWN

Hannibal Clinic

Hannibal, Missouri, 63401, United States

WITHDRAWN

Mercury Street Medical Group

Butte, Montana, 59701, United States

WITHDRAWN

St. Michael's Medical Center

Newark, New Jersey, 07102, United States

WITHDRAWN

Buffalo VA Medical Center

Buffalo, New York, 14215, United States

WITHDRAWN

Lenox Hill Hospital

New York, New York, 10075-1850, United States

RECRUITING

Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

WITHDRAWN

Jefferson University Hospitals

Philadelphia, Pennsylvania, 19107, United States

WITHDRAWN

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

WITHDRAWN

Medical City Fort Worth

Fort Worth, Texas, 76104, United States

WITHDRAWN

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

Sanatorio Parque S.A. Privado

San Vicente, Córdoba Province, 5006, Argentina

WITHDRAWN

CEMIC

Ciudad Autonoma de Buenos Aire, 1431, Argentina

RECRUITING

Sanatorio de la Trinidad Mitre

Ciudad Autonoma de Buenos Aire, C1039AAO, Argentina

WITHDRAWN

Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos Aire, C1181ACH, Argentina

WITHDRAWN

Hospital General de Agudos Dr. Ignacio Pirovano

Ciudad Autonoma de Buenos Aire, C1430BKC, Argentina

WITHDRAWN

Clinica Adventista Belgrano

Ciudad Autonoma de Buenos Aire, C1430EGF, Argentina

WITHDRAWN

Clinica Chutro

Córdoba, 5000, Argentina

WITHDRAWN

Hospital San Roque

Córdoba, 5000, Argentina

RECRUITING

Sanatorio Privado de la Canada - Cordoba

Córdoba, X5000BSQ, Argentina

WITHDRAWN

Centro Medico IPAM

Rosario, S2001SBK, Argentina

WITHDRAWN

Estudios Clinicos de los Arroyos

San Nicolás, 2900, Argentina

RECRUITING

Sanatorio de la Canada

Villa María, 5900, Argentina

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

WITHDRAWN

Monash Medical Centre

Clayton, Victoria, 3168, Australia

RECRUITING

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

RECRUITING

Footscray Hospital

Footscray, 3011, Australia

RECRUITING

Austin Health

Heidelberg, 3084, Australia

RECRUITING

Sunshine Hospital

Saint Albans, 3021, Australia

RECRUITING

KABEG-Klinikum Klagenfurt

Klagenfurt, 9020, Austria

WITHDRAWN

AKH - Medizinische Universität Wien

Vienna, 1090, Austria

WITHDRAWN

Onze Lieve Vrouw Ziekenhuis

Aalst, 9300, Belgium

RECRUITING

AZ Sint-Jan

Bruges, 8000, Belgium

RECRUITING

Hopital Erasme

Brussels, 1070, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Antwerp University Hospital (UZA)

Edegem, 2650, Belgium

RECRUITING

ZOL

Genk, 3600, Belgium

RECRUITING

AZ Maria Middelares

Ghent, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

RECRUITING

C. H. R. de la Citadelle

Liège, 4000, Belgium

RECRUITING

CHU Charleroi Hôpital Civil Marie Curie

Lodelinsart, 6042, Belgium

RECRUITING

Clinique Saint-Pierre

Ottignies, 1340, Belgium

RECRUITING

AZ Delta VZW

Roeselare, 8800, Belgium

RECRUITING

UPECLIN - Unidade de Pesquisa Clínica

Botucatu, 18618-686, Brazil

RECRUITING

HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

Campinas, 13060-904, Brazil

WITHDRAWN

Hospital do Rocio

Campo Largo, 83606-177, Brazil

RECRUITING

Universidade de Caxias do Sul, IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos

Caxias do Sul, 95070-560, Brazil

RECRUITING

Hospital de Clínicas de Passo Fundo

Passo Fundo, 99010-260, Brazil

RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, 90020-090, Brazil

RECRUITING

Hospital de Clínicas de Porto Alegre

Porto Alegre, 90035-903, Brazil

WITHDRAWN

Hospital Ernesto Dornelles

Porto Alegre, 90160-093, Brazil

RECRUITING

CIP - Centro Integrado de Pesquisa

São José do Rio Preto, 15090-000, Brazil

RECRUITING

Hospital Alemão Oswaldo Cruz

São Paulo, 01323-020, Brazil

WITHDRAWN

Universidade Municipal de Sao Caetano do Sul (USCS)

São Paulo, 09530-700, Brazil

WITHDRAWN

Fakultni nemocnice u sv. Anny v Brne

Brno, 65691, Czechia

RECRUITING

Oblastni nemocnice Kolin a.s.

Kolín, 28002, Czechia

RECRUITING

Hospital Kyjov

Kyjov, 69701, Czechia

RECRUITING

Fakultni nemocnice Kralovske Vinohrady

Prague, 10034, Czechia

RECRUITING

Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

RECRUITING

Hôpital Louis Mourier

Colombes, 92700, France

WITHDRAWN

CHU de Grenoble - Hôpital Albert Michallon

Grenoble, 38043, France

RECRUITING

CHRU Lille - Hôpital Salengro

Lille, 59037, France

WITHDRAWN

CHU de Limoges - Hôpital Dupuytren

Limoges, 87000, France

WITHDRAWN

Centre Hospitalier de Melun

Melun, 77000, France

RECRUITING

CHU Nice-Hopital de l' Archet

Nice, 06202, France

RECRUITING

CHU Nice Hopital Pasteur 2

Nice, 6100, France

RECRUITING

Hôpital Bichat - Claude Bernard

Paris, 75018, France

RECRUITING

Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon

Paris, 75020, France

RECRUITING

Hôpital Tenon

Paris, 75020, France

RECRUITING

Hôpital Cochin

Paris, 75679, France

RECRUITING

CHU Reims - Hôpital Robert Debré

Reims, 51100, France

RECRUITING

CHU Rennes - Hôpital Pontchaillou

Rennes, 35000, France

RECRUITING

CHU Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

CHU Strasbourg - Nouvel Hôpital Civil

Strasbourg, 67091, France

RECRUITING

CHU Strasbourg - Hôpital Hautepierre

Strasbourg, 67098, France

WITHDRAWN

Hôpital Sainte Musse

Toulon, 83056, France

WITHDRAWN

CHU Tours - Hôpital Bretonneau

Tours, 37000, France

WITHDRAWN

Hôpital Nord Franche-Comté

Trévenans, 90400, France

RECRUITING

Charité Universitätsmedizin Berlin - Campus Charité Mitte

Berlin, 10117, Germany

WITHDRAWN

Universitaetsklinikum Essen

Essen, 45147, Germany

RECRUITING

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

WITHDRAWN

Medizinische Hochschule Hannover

Hanover, 30625, Germany

WITHDRAWN

Bugat Pal Korhaz

Gyöngyös, 3200, Hungary

WITHDRAWN

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

Gyula, 5700, Hungary

WITHDRAWN

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, 2143, Hungary

WITHDRAWN

Aneszteziologiai es Intenziv Terapias Intezet

Pécs, 7624, Hungary

WITHDRAWN

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, 6725, Hungary

WITHDRAWN

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, 8000, Hungary

RECRUITING

St James's Hospital

Dublin, D08NYH1, Ireland

RECRUITING

Beaumont Hospital

Dublin, D09 V2N0, Ireland

RECRUITING

St Vincents University Hospital

Dublin, Dublin 4, Ireland

RECRUITING

University Hospital Galway

Galway, H91YR71, Ireland

RECRUITING

Soroka Medical Center

Beersheba, 8410101, Israel

RECRUITING

Bnai Zion Medical Center

Haifa, 31048, Israel

RECRUITING

Rambam Medical Center

Haifa, 31096, Israel

RECRUITING

The Lady Davis Carmel Medical Center

Haifa, 3436212, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 4941492, Israel

RECRUITING

Kaplan Medical Center

Rehovot, 761001, Israel

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Middlemore Hospital

Otahuhu, 2025, New Zealand

RECRUITING

Capital, Coast and Hutt Valley District - Wellington Regional Hospital

Wellington, 6021, New Zealand

RECRUITING

Baguio General Hospital and Medical Center

Baguio City, 2600, Philippines

RECRUITING

Dr. Jose N. Rodriguez Memorial Hospital

Caloocan, 1427, Philippines

RECRUITING

Davao Doctors Hospital

Davao City, 8000, Philippines

WITHDRAWN

Southern Philippines Medical Center

Davao City, 8000, Philippines

RECRUITING

St.Paul's Hospital

Iloilo City, 5000, Philippines

WITHDRAWN

West Visayas State University Medical Center

Iloilo City, 5000, Philippines

RECRUITING

Philippine General Hospital

Manila, 1000, Philippines

RECRUITING

Lung Center of the Philippines

Quezon City, 1100, Philippines

RECRUITING

Institutul Clinic Fundeni

Bucharest, 022328, Romania

WITHDRAWN

Spitalul Universitar de Urgenta Bucuresti

Bucharest, 050098, Romania

RECRUITING

Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"

Timișoara, 300723, Romania

RECRUITING

Johese Clinical Research

Centurion, Gauteng, 0157, South Africa

RECRUITING

Emmed Clinical Research

Pretoria, Gauteng, 0002, South Africa

WITHDRAWN

Into Research

Pretoria, Gauteng, 0181, South Africa

WITHDRAWN

Worthwhile Clinical Trials

Johannesburg, 1500, South Africa

WITHDRAWN

RYEXO Clinical Research Zuid Afrikaans Hospital

Pretoria, 0002, South Africa

WITHDRAWN

RYEXO Clinical Research

Pretoria, 0184, South Africa

TERMINATED

Dr JM Engelbrecht Trial Site

Somerset West, 7130, South Africa

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital de la Santa Creu i de Sant Pau

Barcelona, 08041, Spain

RECRUITING

Hospital Universitari Vall d'Hebrón

Barcelona, 8035, Spain

RECRUITING

Hospital Universitari de Bellvitge

Barcelona, 8907, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Hospital Universitari de Girona Dr Josep Trueta

Girona, 17007, Spain

RECRUITING

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

WITHDRAWN

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222, Spain

WITHDRAWN

Hospital Universitario Son Espases

Palma de Mallorca, 07120, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, 31008, Spain

RECRUITING

Hospital Universitari de Tarragona Joan XXIII

Tarragona, 43007, Spain

RECRUITING

Hospital Universitari Mutua de Terrassa

Terrassa, 8221, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

WITHDRAWN

Queen Elizabeth University Campus

Glasgow, G11 6NT, United Kingdom

RECRUITING

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

WITHDRAWN

St Thomas' Hospital

London, SE1 7EH, United Kingdom

RECRUITING

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

trimodulin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Ricard Ferrer Roca, Dr.

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Langohr

CONTACT

+491732947122; patrick.langohr@biotest.com

Claudia Schulte

CONTACT

+4915222801491; claudia.schulte@biotest.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All bottles will be indistinguishable.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized on a 1:1 basis to receive trimodulin or placebo, stratified by center

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 10, 2023
• Study Start: September 9, 2023
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); PH (8); IE (4); IL (7); GB (4); ZA (7); FR (20); NZ (2); BR (11); RO (3); ES (14); US (19); CZ (4); AR (12); BE (12); DE (5); HU (6)