Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) (ESsCAPE)
September 11, 2026 updated by: Biotest
A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase III Trial to Assess the Efficacy and Safety of Trimodulin (BT588) in 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 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
Status
Recruiting
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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 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
Study Type
Interventional
Enrollment (Estimated)
Enrollment
590
Phase
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
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
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Buenos Aires, Argentina, 1431
- Recruiting
- # 5414 Cemic
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Buenos Aires, Argentina, C1181ACH
- Withdrawn
- # 5406 Hospital Italiano de Buenos Aires
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Buenos Aires, Argentina, C1188AAX
- Recruiting
- # 5418 Sanatorio Guemes Site 5418
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Buenos Aires, Argentina, C1221ADC
- Recruiting
- # 5419 Hospital General de Agudos Dr. J. M. Ramos Mejia
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Buenos Aires, Argentina, C1280AEB
- Recruiting
- # 5417 Hospital Britanico de Buenos Aires
-
Buenos Aires, Argentina, C1430BKC
- Withdrawn
- # 5408 Hospital General de Agudos Dr. Ignacio Pirovano
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Buenos Aires, Argentina, C1430EGF
- Withdrawn
- # 5407 Clinica Adventista Belgrano
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Buenos
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San Nicolás, Buenos, Argentina, 2900
- Recruiting
- # 5413 Estudios Clinicos de los Arroyos
-
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Buenos Aires F.D.
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Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, C1039AAO
- Withdrawn
- # 5404 Sanatorio de la Trinidad Mitre
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Córdoba Province
-
Córdoba, Córdoba Province, Argentina, 5000
- Withdrawn
- # 5409 Hospital San Roque
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Córdoba, Córdoba Province, Argentina, 5000
- Withdrawn
- # 5412 Clinica Chutro
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Córdoba, Córdoba Province, Argentina, X5000BSQ
- Withdrawn
- # 5416 Sanatorio Privado de la Canada - Cordoba
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San Vicente, Córdoba Province, Argentina, 5006
- Withdrawn
- # 5405 Sanatorio Parque S.A. Privado
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Villa María, Córdoba Province, Argentina, 5000
- Recruiting
- # 5415 Sanatorio de la Canada
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Recruiting
- # 5420 Sanatorio Parque S.A.
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Rosario, Santa Fe Province, Argentina, CP2000
- Withdrawn
- # 5411 Centro Medico IPAM
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Queensland
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Woolloongabba, Queensland, Australia, 4102
- Withdrawn
- # 6102 Princess Alexandra Hospital
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Victoria
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Clayton, Victoria, Australia, 3168
- Recruiting
- # 6105 Monash Medical Centre
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Footscray, Victoria, Australia, 3011
- Recruiting
- # 6104 Footscray Hospital
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Heidelberg, Victoria, Australia, 3084
- Recruiting
- # 6101 Austin Health
-
Saint Albans, Victoria, Australia, 3021
- Recruiting
- # 6103 Sunshine Hospital
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Recruiting
- # 6106 Sir Charles Gairdner Hospital
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-
-
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Klagenfurt, Austria, 9020
- Withdrawn
- # 4302 KABEG-Klinikum Klagenfurt
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Vienna, Austria, 1090
- Withdrawn
- # 4301 AKH - Medizinische Universität Wien
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-
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Aalst, Belgium, 9300
- Not yet recruiting
- # 3212 Onze Lieve Vrouw Ziekenhuis
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Bruges, Belgium, 8000
- Recruiting
- # 3207 AZ Sint-Jan
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Brussels, Belgium, 1070
- Recruiting
- # 3205 HUB Erasme
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Brussels, Belgium, 1200
- Recruiting
- # 3203 Cliniques Universitaires Saint-Luc
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Edegem, Belgium, 2650
- Recruiting
- # 3206 Antwerp University Hospital (UZA)
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Genk, Belgium, 3600
- Recruiting
- # 3211 Zol
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Ghent, Belgium, 9000
- Recruiting
- # 3210 AZ Maria Middelares
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Jette, Belgium, 1090
- Recruiting
- # 3204 Universitair Ziekenhuis Brussel
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Liège, Belgium, 4000
- Recruiting
- # 3209 C. H. R. de la Citadelle
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Lodelinsart, Belgium, 6042
- Recruiting
- # 3208 CHU Charleroi Hôpital Civil Marie Curie
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Ottignies, Belgium, 1340
- Recruiting
- # 3201 Clinique Saint-Pierre
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Roeselare, Belgium, 8800
- Recruiting
- # 3213 AZ Delta VZW
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-
-
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Paraná
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Campo Largo, Paraná, Brazil, 83606-177
- Recruiting
- # 5516 Hospital do Rocio
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Rio Grande
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Caxias do Sul, Rio Grande, Brazil, 95070-560
- Withdrawn
- # 5510 Universidade de Caxias do Sul, IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos
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Passo Fundo, Rio Grande, Brazil, 99010-260
- Recruiting
- # 5518 Hospital de Clínicas de Passo Fundo
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Porto Alegre, Rio Grande, Brazil, 90020-090
- Recruiting
- # 5503 Irmandade da Santa Casa de Misericórdia de Porto Alegre
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Porto Alegre, Rio Grande, Brazil, 90035-903
- Withdrawn
- # 5507 Hospital de Clínicas de Porto Alegre
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Porto Alegre, Rio Grande, Brazil, 90160-093
- Withdrawn
- # 5509 Hospital Ernesto Dornelles
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Porto Alegre, Rio Grande, Brazil, 90560-032
- Recruiting
- # 5519 Hospital Moinhos de Vento
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São Paulo
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Botucatu, São Paulo, Brazil, 18618-686
- Recruiting
- # 5512 UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
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Campinas, São Paulo, Brazil, 13060-904
- Withdrawn
- # 5508 HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
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São Caetano do Sul, São Paulo, Brazil, 09530-700
- Withdrawn
- # 5514 Universidade Municipal de Sao Caetano do Sul (USCS)
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São José do Rio Preto, São Paulo, Brazil, 15090-000
- Recruiting
- # 5513 Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
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São Paulo, São Paulo, Brazil, 01323-020
- Withdrawn
- # 5517 Hospital Alemão Oswaldo Cruz
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-
-
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Brno, Czechia, 65691
- Recruiting
- #4202 Fakultni nemocnice u sv. Anny v Brne
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Kolín, Czechia, 28002
- Recruiting
- # 4203 Oblastni nemocnice Kolin a.s.
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Kyjov, Czechia, 69701
- Recruiting
- # 4204 Hospital Kyjov
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Prague, Czechia, 10034
- Recruiting
- #4201 Fakultni nemocnice Kralovske Vinohrady
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-
-
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Paris, France, 75014
- Recruiting
- # 3312 Hôpital Cochin
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Paris, France, 75018
- Recruiting
- # 3301 Hôpital Bichat - Claude Bernard
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Paris, France, 75020
- Terminated
- # 3304 Hôpital Tenon
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Paris, France, 75020
- Withdrawn
- # 3316 Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon
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Alpes Maritime
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Nice, Alpes Maritime, France, 06202
- Recruiting
- # 3317 CHU Nice-Hopital de l' Archet
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Nice, Alpes Maritime, France, 6100
- Withdrawn
- # 3320 CHU Nice Hopital Pasteur 2
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Ardennes
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Reims, Ardennes, France, 51100
- Recruiting
- # 3321 CHU Reims - Hôpital Robert Debré
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Bas Rhin
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Strasbourg, Bas Rhin, France, 67091
- Recruiting
- # 3306 CHU Strasbourg - Nouvel Hôpital Civil
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Strasbourg, Bas Rhin, France, 67098
- Withdrawn
- # 3308 CHU Strasbourg - Hôpital Hautepierre
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Haute Vienne
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Limoges, Haute Vienne, France, 87000
- Withdrawn
- # 3311 CHU de Limoges - Hôpital Dupuytren
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Haute de Seine
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Colombes, Haute de Seine, France, 92700
- Withdrawn
- # 3310 Hôpital Louis Mourier
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Ille Et Vilaine
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Rennes, Ille Et Vilaine, France, 35000
- Withdrawn
- # 3319 CHU Rennes - Hôpital Pontchaillou
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Indre Et Loire
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Tours, Indre Et Loire, France, 37000
- Withdrawn
- # 3314 CHU Tours - Hôpital Bretonneau
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Isere
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Grenoble, Isere, France, 38043
- Recruiting
- # 3318 CHU de Grenoble - Hôpital Albert Michallon
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Landes
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Lille, Landes, France, 59037
- Withdrawn
- # 3315 CHRU Lille - Hôpital Salengro
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Pays de la Loire Region
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Saint-Étienne-de-Montluc, Pays de la Loire Region, France, 42055
- Recruiting
- # 3305 CHU Saint-Etienne
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Seine Maritime
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Melun, Seine Maritime, France, 77000
- Recruiting
- # 3303 Centre Hospitalier de Melun
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Territoire De Belfort
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Trévenans, Territoire De Belfort, France, 90400
- Withdrawn
- # 3302 Hôpital Nord Franche-Comté
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Val d'Oise
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Argenteuil, Val d'Oise, France, 95107
- Withdrawn
- # 3309 Centre Hospitalier Victor Dupouy
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Var
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Toulon, Var, France, 83056
- Withdrawn
- # 3313 Hôpital Sainte Musse
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Berlin, Germany, 10117
- Withdrawn
- # 4904 Charité Universitätsmedizin Berlin - Campus Charité Mitte
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Hamburg, Germany, 20246
- Withdrawn
- # 4905 Universitätsklinikum Hamburg-Eppendorf
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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
- Withdrawn
- # 4909 Universitaetsklinikum Freiburg
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Lower Saxony
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Hanover, Lower Saxony, Germany, 30625
- Withdrawn
- # 4903 Medizinische Hochschule Hannover
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North Rhine-Westphalia
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Essen, North Rhine-Westphalia, Germany, 45147
- Recruiting
- # 4910 Universitaetsklinikum Essen
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Gyula, Hungary, 5700
- Withdrawn
- # 3607 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
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Gyöngyös, Hungary, 3200
- Withdrawn
- # 3606 Bugat Pal Korhaz
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Kistarcsa, Hungary, 2143
- Withdrawn
- # 3608 Pest Megyei Flor Ferenc Korhaz
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Pécs, Hungary, 7624
- Withdrawn
- # 3610 Aneszteziologiai es Intenziv Terapias Intezet
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Szeged, Hungary, 6725
- Withdrawn
- # 3612 Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
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Székesfehérvár, Hungary, 8000
- Withdrawn
- # 3604 Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
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Dublin, Ireland, D08NYH1
- Recruiting
- # 3501 St James's Hospital
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Dublin, Ireland, D09 V2N0
- Recruiting
- # 3503 Beaumont Hospital
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Dublin, Ireland, Dublin 4
- Not yet recruiting
- # 3504 St Vincents University Hospital
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Galway, Ireland, H91YR71
- Recruiting
- # 3502 University Hospital Galway
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-
-
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Beersheba, Israel, 8410101
- Recruiting
- # 9704 Soroka Medical Center
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Haifa, Israel, 31048
- Withdrawn
- # 9701 Bnai Zion Medical Center
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Haifa, Israel, 31096
- Withdrawn
- # 9703 Rambam Medical Center
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Haifa, Israel, 3436212
- Withdrawn
- # 9706 The Lady Davis Carmel Medical Center
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Petah Tikva, Israel, 4941492
- Withdrawn
- # 9702 Rabin Medical Center
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Rehovot, Israel, 761001
- Recruiting
- # 9705 Kaplan Medical Center
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Rishon LeZiyyon, Israel, 70300
- Recruiting
- # 9708 Shamir Medical Center (Assaf Harofe)
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Tel Aviv, Israel, 64239
- Withdrawn
- # 9707 Tel Aviv Sourasky Medical Center
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-
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Otahuhu, New Zealand, 2025
- Recruiting
- # 6401 Middlemore Hospital
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Wellington, New Zealand, 6021
- Recruiting
- # 6403 Capital, Coast and Hutt Valley District - Wellington Regional Hospital
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Baguio City, Philippines, 2600
- Withdrawn
- # 6302 Baguio General Hospital and Medical Center
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Caloocan, Philippines, 1427
- Recruiting
- # 6307 Dr. Jose N. Rodriguez Memorial Hospital
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Davao City, Philippines, 8000
- Recruiting
- # 6304 Southern Philippines Medical Center
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Davao City, Philippines, 8000
- Withdrawn
- # 6309 Davao Doctors Hospital
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Iloilo City, Philippines, 5000
- Recruiting
- # 6301 West Visayas State University Medical Center
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Iloilo City, Philippines, 5000
- Withdrawn
- # 6306 St.Paul's Hospital
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Manila, Philippines, 1000
- Recruiting
- # 6308 Philippine General Hospital
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Quezon City, Philippines, 1100
- Withdrawn
- # 6303 Lung Center of the Philippines
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Bucharest, Romania, 022328
- Withdrawn
- # 4001 Institutul Clinic Fundeni
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Bucharest, Romania, 050098
- Recruiting
- # 4003 Spitalul Universitar de Urgenta Bucuresti
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Timișoara, Romania, 300723
- Withdrawn
- # 4002 Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"
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Johannesburg, South Africa, 1500
- Withdrawn
- # 2703 Worthwhile Clinical Trials
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Pretoria, South Africa, 0002
- Withdrawn
- # 2704 RYEXO Clinical Research Zuid Afrikaans Hospital
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Pretoria, South Africa, 0184
- Terminated
- # 2705 RYEXO Clinical Research
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Gauteng
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Centurion, Gauteng, South Africa, 0157
- Withdrawn
- # 2706 Johese Clinical Research
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Pretoria, Gauteng, South Africa, 0002
- Withdrawn
- # 2707 Emmed Clinical Research
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Pretoria, Gauteng, South Africa, 0181
- Withdrawn
- # 2708 Into Research
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Western Cape
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Somerset West, Western Cape, South Africa, 7130
- Withdrawn
- # 2701 Dr JM Engelbrecht Trial Site
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-
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Barcelona, Spain, 08003
- Withdrawn
- # 3414 Hospital del Mar
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Barcelona, Spain, 08036
- Recruiting
- # 3408 Hospital Clinic de Barcelona
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Barcelona, Spain, 08036
- Not yet recruiting
- # 3421 Hospital Clinic de Barcelona
-
Barcelona, Spain, 08041
- Recruiting
- # 3406 Hospital de la Santa Creu i de Sant Pau
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Barcelona, Spain, 8035
- Recruiting
- # 3407 Hospital Universitari Vall d'Hebrón
-
Barcelona, Spain, 8907
- Recruiting
- # 3417 Hospital Universitari de Bellvitge
-
Girona, Spain, 17007
- Recruiting
- # 3411 Hospital Universitari de Girona Dr Josep Trueta
-
Madrid, Spain, 28040
- Withdrawn
- # 3413 Hospital Universitario Clinico San Carlos
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Madrid, Spain, 28046
- Withdrawn
- # 3415 Hospital Universitario La Paz
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Seville, Spain, 41013
- Recruiting
- # 3422 Hospital Universitario Virgen del Rocio
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Tarragona, Spain, 43007
- Recruiting
- # 3404 Hospital Universitari de Tarragona Joan XXIII
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Valencia, Spain, 46026
- Withdrawn
- # 3416 Hospital Universitari i Politecnic La Fe
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Balearic Islands
-
Palma de Mallorca, Balearic Islands, Spain, 07120
- Recruiting
- # 3409 Hospital Universitario Son Espases
-
-
Barcelona
-
Sabadell, Barcelona, Spain, 08208
- Recruiting
- # 3423 Hospital Universitari Parc Tauli
-
Terrassa, Barcelona, Spain, 8221
- Recruiting
- # 3419 Hospital Universitari Mutua de Terrassa
-
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Cordoba
-
Córdoba, Cordoba, Spain, 14004
- Recruiting
- # 3405 Hospital Universitario Reina Sofia
-
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Madrid
-
Majadahonda, Madrid, Spain, 28222
- Withdrawn
- # 3410 Hospital Universitario Puerta de Hierro Majadahonda
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Navarre
-
Pamplona, Navarre, Spain, 31008
- Recruiting
- # 3418 Clinica Universidad de Navarra
-
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Principality of Asturias
-
Oviedo, Principality of Asturias, Spain, 33011
- Not yet recruiting
- # 3420 Hospital Universitario Central de Asturias
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-
-
-
Cardiff, United Kingdom, CF14 4XW
- Not yet recruiting
- # 4411 University Hospital of Wales
-
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Devon
-
Plymouth, Devon, United Kingdom, PL6 8DH
- Recruiting
- # 4405 Derriford Hospital
-
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Greater London
-
London, Greater London, United Kingdom, SE1 7EH
- Recruiting
- # 4401 St Thomas' Hospital
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London, Greater London, United Kingdom, SE5 9RS
- Not yet recruiting
- # 4410 King's College Hospital
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Strathclyde
-
Glasgow, Strathclyde, United Kingdom, G11 6NT
- Withdrawn
- # 4403 Queen Elizabeth University Campus
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Surrey
-
Guildford, Surrey, United Kingdom, GU2 7XX
- Withdrawn
- # 4404 Royal Surrey County Hospital
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-
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Alabama
-
Mobile, Alabama, United States, 36608
- Withdrawn
- #1012 Pulmonary Associates of Mobile, P.C.
-
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Arizona
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Phoenix, Arizona, United States, 85006
- Not yet recruiting
- # 1033 Banner University Medical Center
-
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California
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Fresno, California, United States, 93701
- Recruiting
- #1007 University of California San Francisco-Fresno
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Sacramento, California, United States, 95817
- Withdrawn
- # 1015 UC Davis Health
-
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Georgia
-
Augusta, Georgia, United States, 30912
- Withdrawn
- # 1002 Augusta University
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Not yet recruiting
- # 1028 University of Maryland, Baltimore
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Not yet recruiting
- # 1034 Brigham and Women's Hospital
-
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Michigan
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Lansing, Michigan, United States, 48912
- Withdrawn
- # 1010 Sparrow Clinical Research Institute Site 1010
-
Royal Oak, Michigan, United States, 48073
- Withdrawn
- # 1003 William Beaumont Hospital
-
-
Missouri
-
Columbia, Missouri, United States, 65212
- Withdrawn
- #1009 University of Missouri Clinical Research Center
-
Hannibal, Missouri, United States, 63401
- Withdrawn
- # 1006 Hannibal Clinic
-
-
Montana
-
Butte, Montana, United States, 59701
- Withdrawn
- # 1005 Mercury Street Medical Group
-
-
New Jersey
-
Newark, New Jersey, United States, 07102
- Withdrawn
- # 1001 St. Michael's Medical Center
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-
New York
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Buffalo, New York, United States, 14215
- Withdrawn
- # 1011 Buffalo VA Medical Center
-
Mount Kisco, New York, United States, 10549
- Recruiting
- # 1021 Northern Westchester Hospital
-
New York, New York, United States, 10016
- Not yet recruiting
- # 1030 NYU Langone Medical Center (Tisch Hospital)
-
New York, New York, United States, 10016
- Not yet recruiting
- # 1031 Health Hospitals Bellvue
-
New York, New York, United States, 10029
- Not yet recruiting
- # 1023 Mount Sinai Hospital
-
New York, New York, United States, 11220
- Not yet recruiting
- # 1032 NYC Langone Brooklyn
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- # 1017 Wake Forest Baptist
-
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Ohio
-
Cincinnati, Ohio, United States, 45267
- Not yet recruiting
- # 1025 University of Cincinnati College of Medicine
-
Columbus, Ohio, United States, 43210
- Active, not recruiting
- # 1004 Ohio State University Wexner Medical Center
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Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Withdrawn
- # 1013 University of Oklahoma Health Sciences Center
-
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Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Withdrawn
- # 1016 Jefferson University Hospitals
-
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Tennessee
-
Nashville, Tennessee, United States, 37232
- Withdrawn
- # 1018 Vanderbilt University Medical Cente
-
-
Texas
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Fort Worth, Texas, United States, 76104
- Withdrawn
- # 1020 Medical City Fort Worth
-
Houston, Texas, United States, 77030
- Recruiting
- # 1022 Houston Methodist Hospital
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Houston, Texas, United States, 77030
- Not yet recruiting
- # 1022 Houston Methodist Hospital
-
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Utah
-
Murray, Utah, United States, 84107
- Not yet recruiting
- # 1026 Intermountain Medical Center
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Salt Lake City, Utah, United States, 84108
- Withdrawn
- # 1019 University of Utah
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Main Inclusion Criteria:
- Written informed consent.
- Hospitalized, adult (≥ 18 years of age) subject; In US only: ≥ 12 years of age
- 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.
Main 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 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.
- 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.
- 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.
- Treatment with polyvalent immunoglobulin preparations during the last 21 days before start of IMP treatment.
- Known treatment with predefined medications, during the last 2 days before start of IMP treatment.
- Hematopoietic stem cell transplantation or previous lung transplantation.
- 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
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?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
2
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Trimodulin
Trimodulin (human IgM, IgA, IgG solution) for intravenous (IV) administration.
|
IMP will be administered via IV infusion on 5 consecutive days
Other Names:
|
|
Placebo Comparator: Placebo
Human albumin 1%
|
IMP will be administered via IV infusion on 5 consecutive days
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
28-day all-cause mortality rate
Time Frame: Between days 1-29
|
Percentage of subjects that died until day 29 regardless of cause of death
|
Between days 1-29
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
90-day all-cause mortality rate
Time Frame: Between days 1-91
|
Percentage of subjects that died until day 91 regardless of cause of death
|
Between days 1-91
|
|
Ventilator-free days (VFD) until day 29
Time Frame: Until day 29
|
Ventilator-free days (VFD)
|
Until day 29
|
|
Time to discharge from ICU
Time Frame: Until day 91
|
Time to discharge from ICU
|
Until day 91
|
|
Proportion of subjects in ICU on days 7, 14, 21 and 29
Time Frame: On days 7, 14, 21, 29
|
Percentage of subjects in ICU
|
On days 7, 14, 21, 29
|
|
Time to discharge from hospital
Time Frame: Until day 91
|
Time to discharge from hospital
|
Until day 91
|
|
Proportion of subjects in hospital on days 7, 14, 21 and 29
Time Frame: On days 7, 14, 21, 29
|
Percentage of subjects in hospital
|
On days 7, 14, 21, 29
|
|
28-day readmission rate
Time Frame: Day 29
|
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
Time Frame: Between Days 29 - 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
Time Frame: Between Days 29 - 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
Time Frame: Day 1-5
|
Dose modifications (including reductions and changes in infusion rate)
|
Day 1-5
|
|
Change over time in electrocardiogram (ECG) parameters
Time Frame: Days -1, 1, 3, 5 and once between days 8-13
|
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
Time Frame: Days -1, 1-5, 7, 14, 21, 29
|
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)
Time Frame: 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
Time Frame: Between baseline and 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Up to day 29
|
Days of hospitalization
|
Up to day 29
|
|
Time to return to normal activities up to day 91
Time Frame: 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
Time Frame: Up to day 29
|
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
Time Frame: Up to day 91
|
Number of all infusion-related TEAEs
|
Up to day 91
|
|
Serious adverse events (SAEs)
Time Frame: Up to day 29
|
Number, severity, causality, and outcome of all SAEs
|
Up to day 29
|
|
Number and changes in observed Adverse Events in vital signs over time
Time Frame: Days -1, 1-5, 7, 14, 21, 29
|
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
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum concentration of immunoglobulins
Time Frame: Day 1, 5, 14
|
Changes of serum concentration of IgM, IgA, and IgG from baseline, during and after treatment
|
Day 1, 5, 14
|
|
Pharmacokinetic assessment of immunoglobulins
Time Frame: Day 1, 2, 3, 4, 5, 6, 7, 9, 14, 21, 29
|
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
Time Frame: Day 1, 2, 3, 4, 5, 7, 14, 21, 29
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Ricard Ferrer Roca, Dr., Hospital Vall d'hebrón
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
Study Start
September 9, 2023
Primary Completion (Estimated)
Primary Completion
July 31, 2028
Study Completion (Estimated)
Study Completion
July 31, 2028
Study Registration Dates
First Submitted
First Submitted
January 11, 2023
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
January 31, 2023
First Posted (Actual)
First Posted
February 10, 2023
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
September 14, 2026
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
September 11, 2026
Last Verified
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.