Community-acquired PneumoniaPhase 3ESsCAPENCT05722938
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
A Phase 3 study testing Trimodulin in people with Community-acquired Pneumonia, run by Biotest at 170 sites in 18 countries.
Trial 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 hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Trimodulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 590 participants
- Where
- 170 sitesin 18 countries
- Study dates
- 9 Sep 2023to 31 Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
170 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
170 sites in 18 countries
United States30 sites, 14 recruiting
- Withdrawn
# 1002 Augusta University
Augusta, Georgia, 30912
- Not yet recruiting
# 1028 University of Maryland, Baltimore
Baltimore, Maryland, 21201
- Not yet recruiting
# 1034 Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Withdrawn
# 1011 Buffalo VA Medical Center
Buffalo, New York, 14215
- Withdrawn
# 1005 Mercury Street Medical Group
Butte, Montana, 59701
- Not yet recruiting
# 1025 University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
- Withdrawn
#1009 University of Missouri Clinical Research Center
Columbia, Missouri, 65212
- Active, not recruiting
# 1004 Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
- Withdrawn
# 1020 Medical City Fort Worth
Fort Worth, Texas, 76104
- Recruiting
#1007 University of California San Francisco-Fresno
Fresno, California, 93701
- Withdrawn
# 1006 Hannibal Clinic
Hannibal, Missouri, 63401
- Recruiting
# 1022 Houston Methodist Hospital
Houston, Texas, 77030
- Not yet recruiting
# 1022 Houston Methodist Hospital
Houston, Texas, 77030
- Withdrawn
# 1010 Sparrow Clinical Research Institute Site 1010
Lansing, Michigan, 48912
- Withdrawn
#1012 Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, 36608
- Recruiting
# 1021 Northern Westchester Hospital
Mount Kisco, New York, 10549
- Not yet recruiting
# 1026 Intermountain Medical Center
Murray, Utah, 84107
- Withdrawn
# 1018 Vanderbilt University Medical Cente
Nashville, Tennessee, 37232
- Not yet recruiting
# 1030 NYU Langone Medical Center (Tisch Hospital)
New York, New York, 10016
- Not yet recruiting
# 1031 Health Hospitals Bellvue
New York, New York, 10016
- Not yet recruiting
# 1023 Mount Sinai Hospital
New York, New York, 10029
- Not yet recruiting
# 1032 NYC Langone Brooklyn
New York, New York, 11220
- Withdrawn
# 1001 St. Michael's Medical Center
Newark, New Jersey, 07102
- Withdrawn
# 1013 University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
- Withdrawn
# 1016 Jefferson University Hospitals
Philadelphia, Pennsylvania, 19107
- Not yet recruiting
# 1033 Banner University Medical Center
Phoenix, Arizona, 85006
- Withdrawn
# 1003 William Beaumont Hospital
Royal Oak, Michigan, 48073
- Withdrawn
# 1015 UC Davis Health
Sacramento, California, 95817
- Withdrawn
# 1019 University of Utah
Salt Lake City, Utah, 84108
- Recruiting
# 1017 Wake Forest Baptist
Winston-Salem, North Carolina, 27157
France20 sites, 8 recruiting
- Withdrawn
# 3309 Centre Hospitalier Victor Dupouy
Argenteuil, Val d'Oise, 95107
- Withdrawn
# 3310 Hôpital Louis Mourier
Colombes, Haute de Seine, 92700
- Recruiting
# 3318 CHU de Grenoble - Hôpital Albert Michallon
Grenoble, Isere, 38043
- Withdrawn
# 3315 CHRU Lille - Hôpital Salengro
Lille, Landes, 59037
- Withdrawn
# 3311 CHU de Limoges - Hôpital Dupuytren
Limoges, Haute Vienne, 87000
- Recruiting
# 3303 Centre Hospitalier de Melun
Melun, Seine Maritime, 77000
- Recruiting
# 3317 CHU Nice-Hopital de l' Archet
Nice, Alpes Maritime, 06202
- Withdrawn
# 3320 CHU Nice Hopital Pasteur 2
Nice, Alpes Maritime, 6100
- Recruiting
# 3312 Hôpital Cochin
Paris, 75014
- Recruiting
# 3301 Hôpital Bichat - Claude Bernard
Paris, 75018
- Terminated
# 3304 Hôpital Tenon
Paris, 75020
- Withdrawn
# 3316 Groupe Hospitalier Diaconesses - Hopital De La Croix Saint Simon
Paris, 75020
- Recruiting
# 3321 CHU Reims - Hôpital Robert Debré
Reims, Ardennes, 51100
- Withdrawn
# 3319 CHU Rennes - Hôpital Pontchaillou
Rennes, Ille Et Vilaine, 35000
- Recruiting
# 3305 CHU Saint-Etienne
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055
- Recruiting
# 3306 CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, Bas Rhin, 67091
- Withdrawn
# 3308 CHU Strasbourg - Hôpital Hautepierre
Strasbourg, Bas Rhin, 67098
- Withdrawn
# 3313 Hôpital Sainte Musse
Toulon, Var, 83056
- Withdrawn
# 3314 CHU Tours - Hôpital Bretonneau
Tours, Indre Et Loire, 37000
- Withdrawn
# 3302 Hôpital Nord Franche-Comté
Trévenans, Territoire De Belfort, 90400
Spain19 sites, 14 recruiting
- Withdrawn
# 3414 Hospital del Mar
Barcelona, 08003
- Recruiting
# 3408 Hospital Clinic de Barcelona
Barcelona, 08036
- Not yet recruiting
# 3421 Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
# 3406 Hospital de la Santa Creu i de Sant Pau
Barcelona, 08041
- Recruiting
# 3407 Hospital Universitari Vall d'Hebrón
Barcelona, 8035
- Recruiting
# 3417 Hospital Universitari de Bellvitge
Barcelona, 8907
- Recruiting
# 3405 Hospital Universitario Reina Sofia
Córdoba, Cordoba, 14004
- Recruiting
# 3411 Hospital Universitari de Girona Dr Josep Trueta
Girona, 17007
- Withdrawn
# 3413 Hospital Universitario Clinico San Carlos
Madrid, 28040
- Withdrawn
# 3415 Hospital Universitario La Paz
Madrid, 28046
- Withdrawn
# 3410 Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
- Not yet recruiting
# 3420 Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
- Recruiting
# 3409 Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
- Recruiting
# 3418 Clinica Universidad de Navarra
Pamplona, Navarre, 31008
- Recruiting
# 3423 Hospital Universitari Parc Tauli
Sabadell, Barcelona, 08208
- Recruiting
# 3422 Hospital Universitario Virgen del Rocio
Seville, 41013
- Recruiting
# 3404 Hospital Universitari de Tarragona Joan XXIII
Tarragona, 43007
- Recruiting
# 3419 Hospital Universitari Mutua de Terrassa
Terrassa, Barcelona, 8221
- Withdrawn
# 3416 Hospital Universitari i Politecnic La Fe
Valencia, 46026
Argentina16 sites, 7 recruiting
- Recruiting
# 5414 Cemic
Buenos Aires, 1431
- Withdrawn
# 5406 Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH
- Recruiting
# 5418 Sanatorio Guemes Site 5418
Buenos Aires, C1188AAX
- Recruiting
# 5419 Hospital General de Agudos Dr. J. M. Ramos Mejia
Buenos Aires, C1221ADC
- Recruiting
# 5417 Hospital Britanico de Buenos Aires
Buenos Aires, C1280AEB
- Withdrawn
# 5408 Hospital General de Agudos Dr. Ignacio Pirovano
Buenos Aires, C1430BKC
- Withdrawn
# 5407 Clinica Adventista Belgrano
Buenos Aires, C1430EGF
- Withdrawn
# 5404 Sanatorio de la Trinidad Mitre
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1039AAO
- Withdrawn
# 5409 Hospital San Roque
Córdoba, Córdoba Province, 5000
- Withdrawn
# 5412 Clinica Chutro
Córdoba, Córdoba Province, 5000
- Withdrawn
# 5416 Sanatorio Privado de la Canada - Cordoba
Córdoba, Córdoba Province, X5000BSQ
- Recruiting
# 5420 Sanatorio Parque S.A.
Rosario, Santa Fe Province, 2000
- Withdrawn
# 5411 Centro Medico IPAM
Rosario, Santa Fe Province, CP2000
- Recruiting
# 5413 Estudios Clinicos de los Arroyos
San Nicolás, Buenos, 2900
- Withdrawn
# 5405 Sanatorio Parque S.A. Privado
San Vicente, Córdoba Province, 5006
- Recruiting
# 5415 Sanatorio de la Canada
Villa María, Córdoba Province, 5000
Belgium12 sites, 12 recruiting
- Not yet recruiting
# 3212 Onze Lieve Vrouw Ziekenhuis
Aalst, 9300
- Recruiting
# 3207 AZ Sint-Jan
Bruges, 8000
- Recruiting
# 3205 HUB Erasme
Brussels, 1070
- Recruiting
# 3203 Cliniques Universitaires Saint-Luc
Brussels, 1200
- Recruiting
# 3206 Antwerp University Hospital (UZA)
Edegem, 2650
- Recruiting
# 3211 Zol
Genk, 3600
- Recruiting
# 3210 AZ Maria Middelares
Ghent, 9000
- Recruiting
# 3204 Universitair Ziekenhuis Brussel
Jette, 1090
- Recruiting
# 3209 C. H. R. de la Citadelle
Liège, 4000
- Recruiting
# 3208 CHU Charleroi Hôpital Civil Marie Curie
Lodelinsart, 6042
- Recruiting
# 3201 Clinique Saint-Pierre
Ottignies, 1340
- Recruiting
# 3213 AZ Delta VZW
Roeselare, 8800
Brazil12 sites, 6 recruiting
- Recruiting
# 5512 UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, 18618-686
- Withdrawn
# 5508 HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
Campinas, São Paulo, 13060-904
- Recruiting
# 5516 Hospital do Rocio
Campo Largo, Paraná, 83606-177
- Withdrawn
# 5510 Universidade de Caxias do Sul, IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos
Caxias do Sul, Rio Grande, 95070-560
- Recruiting
# 5518 Hospital de Clínicas de Passo Fundo
Passo Fundo, Rio Grande, 99010-260
- Recruiting
# 5503 Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande, 90020-090
- Withdrawn
# 5507 Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande, 90035-903
- Withdrawn
# 5509 Hospital Ernesto Dornelles
Porto Alegre, Rio Grande, 90160-093
- Recruiting
# 5519 Hospital Moinhos de Vento
Porto Alegre, Rio Grande, 90560-032
- Withdrawn
# 5514 Universidade Municipal de Sao Caetano do Sul (USCS)
São Caetano do Sul, São Paulo, 09530-700
- Recruiting
# 5513 Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
- Withdrawn
# 5517 Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, 01323-020
Israel8 sites, 3 recruiting
- Recruiting
# 9704 Soroka Medical Center
Beersheba, 8410101
- Withdrawn
# 9701 Bnai Zion Medical Center
Haifa, 31048
- Withdrawn
# 9703 Rambam Medical Center
Haifa, 31096
- Withdrawn
# 9706 The Lady Davis Carmel Medical Center
Haifa, 3436212
- Withdrawn
# 9702 Rabin Medical Center
Petah Tikva, 4941492
- Recruiting
# 9705 Kaplan Medical Center
Rehovot, 761001
- Recruiting
# 9708 Shamir Medical Center (Assaf Harofe)
Rishon LeZiyyon, 70300
- Withdrawn
# 9707 Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Philippines8 sites, 4 recruiting
- Withdrawn
# 6302 Baguio General Hospital and Medical Center
Baguio City, 2600
- Recruiting
# 6307 Dr. Jose N. Rodriguez Memorial Hospital
Caloocan, 1427
- Recruiting
# 6304 Southern Philippines Medical Center
Davao City, 8000
- Withdrawn
# 6309 Davao Doctors Hospital
Davao City, 8000
- Recruiting
# 6301 West Visayas State University Medical Center
Iloilo City, 5000
- Withdrawn
# 6306 St.Paul's Hospital
Iloilo City, 5000
- Recruiting
# 6308 Philippine General Hospital
Manila, 1000
- Withdrawn
# 6303 Lung Center of the Philippines
Quezon City, 1100
South Africa7 sites
- Withdrawn
# 2706 Johese Clinical Research
Centurion, Gauteng, 0157
- Withdrawn
# 2703 Worthwhile Clinical Trials
Johannesburg, 1500
- Withdrawn
# 2707 Emmed Clinical Research
Pretoria, Gauteng, 0002
- Withdrawn
# 2708 Into Research
Pretoria, Gauteng, 0181
- Withdrawn
# 2704 RYEXO Clinical Research Zuid Afrikaans Hospital
Pretoria, 0002
- Terminated
# 2705 RYEXO Clinical Research
Pretoria, 0184
- Withdrawn
# 2701 Dr JM Engelbrecht Trial Site
Somerset West, Western Cape, 7130
Australia6 sites, 5 recruiting
- Recruiting
# 6105 Monash Medical Centre
Clayton, Victoria, 3168
- Recruiting
# 6104 Footscray Hospital
Footscray, Victoria, 3011
- Recruiting
# 6101 Austin Health
Heidelberg, Victoria, 3084
- Recruiting
# 6106 Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
- Recruiting
# 6103 Sunshine Hospital
Saint Albans, Victoria, 3021
- Withdrawn
# 6102 Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Hungary6 sites
- Withdrawn
# 3606 Bugat Pal Korhaz
Gyöngyös, 3200
- Withdrawn
# 3607 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Gyula, 5700
- Withdrawn
# 3608 Pest Megyei Flor Ferenc Korhaz
Kistarcsa, 2143
- Withdrawn
# 3610 Aneszteziologiai es Intenziv Terapias Intezet
Pécs, 7624
- Withdrawn
# 3612 Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6725
- Withdrawn
# 3604 Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000
United Kingdom6 sites, 4 recruiting
- Not yet recruiting
# 4411 University Hospital of Wales
Cardiff, CF14 4XW
- Withdrawn
# 4403 Queen Elizabeth University Campus
Glasgow, Strathclyde, G11 6NT
- Withdrawn
# 4404 Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX
- Recruiting
# 4401 St Thomas' Hospital
London, Greater London, SE1 7EH
- Not yet recruiting
# 4410 King's College Hospital
London, Greater London, SE5 9RS
- Recruiting
# 4405 Derriford Hospital
Plymouth, Devon, PL6 8DH
Germany5 sites, 1 recruiting
- Withdrawn
# 4904 Charité Universitätsmedizin Berlin - Campus Charité Mitte
Berlin, 10117
- Recruiting
# 4910 Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, 45147
- Withdrawn
# 4909 Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
- Withdrawn
# 4905 Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
- Withdrawn
# 4903 Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Czechia4 sites, 4 recruiting
- Recruiting
#4202 Fakultni nemocnice u sv. Anny v Brne
Brno, 65691
- Recruiting
# 4203 Oblastni nemocnice Kolin a.s.
Kolín, 28002
- Recruiting
# 4204 Hospital Kyjov
Kyjov, 69701
- Recruiting
#4201 Fakultni nemocnice Kralovske Vinohrady
Prague, 10034
Ireland4 sites, 4 recruiting
- Recruiting
# 3501 St James's Hospital
Dublin, D08NYH1
- Recruiting
# 3503 Beaumont Hospital
Dublin, D09 V2N0
- Not yet recruiting
# 3504 St Vincents University Hospital
Dublin, Dublin 4
- Recruiting
# 3502 University Hospital Galway
Galway, H91YR71
Romania3 sites, 1 recruiting
- Withdrawn
# 4001 Institutul Clinic Fundeni
Bucharest, 022328
- Recruiting
# 4003 Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098
- Withdrawn
# 4002 Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"
Timișoara, 300723
Austria2 sites
- Withdrawn
# 4302 KABEG-Klinikum Klagenfurt
Klagenfurt, 9020
- Withdrawn
# 4301 AKH - Medizinische Universität Wien
Vienna, 1090
New Zealand2 sites, 2 recruiting
- Recruiting
# 6401 Middlemore Hospital
Otahuhu, 2025
- Recruiting
# 6403 Capital, Coast and Hutt Valley District - Wellington Regional Hospital
Wellington, 6021
About this study
Official title: 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.
Read the 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.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Trimodulin, Placebo (human albumin 1%)
- Keywords
- Severe Community-acquired Pneumonia
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimodulinDrug
Also called BT588
IMP will be administered via IV infusion on 5 consecutive days
Placebo (human albumin 1%)Drug
IMP will be administered via IV infusion on 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Trimodulin | Experimental | Trimodulin (human IgM, IgA, IgG solution) for intravenous (IV) administration. Receives: Drug: Trimodulin |
| Placebo | Placebo comparator | Human albumin 1% Receives: Drug: Placebo (human albumin 1%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality rate
Percentage of subjects that died until day 29 regardless of cause of death
Measured: Between days 1-29
Secondary outcomes (25)
90-day all-cause mortality rate
Percentage of subjects that died until day 91 regardless of cause of death
Measured: Between days 1-91
Deterioration rate (up to day 29)
Percentage of subjects with at least one deterioration event up to day 29
Measured: Up to day 29
Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7
Change in Sequential Organ Failure Assessment (SOFA)
Measured: 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
Measured: Up to day 29
Days of invasive mechanical ventilation (IMV) up to day 29
Days of invasive mechanical ventilation (IMV) up to day 29
Measured: Up to day 29
Ventilator-free days (VFD) until day 29
Ventilator-free days (VFD)
Measured: Until day 29
Days with oxygen supply up to day 29
Days with oxygen supply
Measured: Up to day 29
Proportion of subjects with oxygen supply on days 7, 14, 21 and 29
Percentage of subjects with oxygen supply
Measured: 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
Measured: Up to day 29
Time to discharge from ICU
Time to discharge from ICU
Measured: Until day 91
Proportion of subjects in ICU on days 7, 14, 21 and 29
Percentage of subjects in ICU
Measured: On days 7, 14, 21, 29
Days of hospitalization up to day 29
Days of hospitalization
Measured: Up to day 29
Time to discharge from hospital
Time to discharge from hospital
Measured: Until day 91
Proportion of subjects in hospital on days 7, 14, 21 and 29
Percentage of subjects in hospital
Measured: On days 7, 14, 21, 29
28-day readmission rate
Percentage of subjects readmitted to the hospital
Measured: 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
Measured: Between Days 29 - 91
Time to return to normal activities up to day 91
Time to return to normal activities
Measured: 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)
Measured: 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
Measured: Up to day 29
Infusion-related TEAEs
Number of all infusion-related TEAEs
Measured: Up to day 91
Serious adverse events (SAEs)
Number, severity, causality, and outcome of all SAEs
Measured: Up to day 29
Dose modifications
Dose modifications (including reductions and changes in infusion rate)
Measured: 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
Measured: 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
Measured: 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
Measured: Days -1, 1-5, 7, 14, 21, 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start9 Sep 2023
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized on a 1:1 basis to receive trimodulin or placebo, stratified by center
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotest
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ricard Ferrer Roca, Dr., Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722938
- Sponsor's protocol ID
- 996
- Acronym
- ESsCAPE
- Status last verified
- Sep 2026
- First submitted
- 11 Jan 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05722938
- Acronym / sponsor ID
- ESsCAPE / 996
- Conditions
- Community-acquired Pneumonia
- Keywords
- Severe Community-acquired Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- BiotestIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2023 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized on a 1:1 basis to receive trimodulin or placebo, stratified by center
| Arm | Type | Receives |
|---|---|---|
| Trimodulin | Experimental | Drug: TrimodulinTrimodulin (human IgM, IgA, IgG solution) for intravenous (IV) administration. |
| Placebo | Placebo comparator | Drug: Placebo (human albumin 1%)Human albumin 1% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrimodulinAlso: BT588IMP will be administered via IV infusion on 5 consecutive days | Drug | Trimodulin |
| Placebo (human albumin 1%)IMP will be administered via IV infusion on 5 consecutive days | Drug | Placebo |
Primary outcome
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
25 secondary outcomes
90-day all-cause mortality rate
Time frame: Between days 1-91
Deterioration rate (up to day 29)
Time frame: Up to day 29
Change in Sequential Organ Failure Assessment (SOFA) score from baseline to day 7
Time frame: Between baseline and Day 7
Proportion of subjects with clinical cure of pneumonia up to day 29
Time frame: 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
Time frame: Until day 29
Days with oxygen supply up to day 29
Time frame: 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
Days in intensive care unit (ICU) up to day 29
Time frame: Up to day 29
Time to discharge from ICU
Time frame: Until day 91
Proportion of subjects in ICU on days 7, 14, 21 and 29
Time frame: On days 7, 14, 21, 29
Days of hospitalization up to day 29
Time frame: Up to day 29
Time to discharge from hospital
Time frame: Until day 91
Proportion of subjects in hospital on days 7, 14, 21 and 29
Time frame: On days 7, 14, 21, 29
28-day readmission rate
Time frame: 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
Time to return to normal activities up to day 91
Time frame: Up to day 91
Health status based on Clinical Frailty Scale (CFS) on day 91
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
Time frame: Up to day 29
Infusion-related TEAEs
Time frame: Up to day 91
Serious adverse events (SAEs)
Time frame: Up to day 29
Dose modifications
Time frame: Day 1-5
Change over time in electrocardiogram (ECG) parameters
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
Time frame: Days -1, 1-5, 7, 14, 21, 29
Number and changes in observed Adverse Events in clinical laboratory parameters over time
Time frame: Days -1, 1-5, 7, 14, 21, 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ricard Ferrer Roca, Dr. principal investigator
Hospital Vall d'Hebron
170 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trimodulin in people with Community-acquired Pneumonia, run by Biotest at 170 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 170 sites in United States, France, Spain, Argentina, Belgium and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Langohr (+491732947122, patrick.langohr@biotest.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all-cause mortality rate (time frame: Between days 1-29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.