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

Primary Purpose

Community-acquired Pneumonia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trimodulin
Placebo (human albumin 1%)
Sponsored by
Biotest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring Severe Community-acquired Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria: Written informed consent. Hospitalized, adult (≥ 18 years of age) subject. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) negative status. Signs of inflammation based on C-reactive protein threshold level. Diagnosis of active pneumonia. 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 not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment. Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP). Diagnosis of COVID-19 during the last 4 weeks. Subjects that required oxygen therapy due to COVID-19 in the last 6 months. Defined neutrophil counts within 24 hours prior to start of IMP treatment. Defined platelet counts within 24 hours prior to start of IMP treatment. Defined hemoglobin within 24 hours prior to start of IMP treatment. Known hemolytic disease. Known thrombosis or thromboembolic events (TEEs) or known medical history of TEEs or subjects particularly at risk for TEEs. Subject on dialysis or with severe renal impairment within 24 hours prior to start of IMP treatment. Subject with end-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS). Known severe lung diseases interfering with sCAP therapy (e.g., subjects with chronic obstructive pulmonary disease [COPD], severe interstitial lung disease [incl. idiopathic pulmonary fibrosis], cystic fibrosis, active tuberculosis, chronically infected bronchiectasis, or active lung cancer). Known decompensated heart failure. Known pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh score ≥ 9 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. Known treatment for thorax/head/neck/hematologic malignancies in the last 12 months before screening. 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. Known treatment with polyvalent immunoglobulin preparations, plasma, or albumin preparations during the last 21 days before screening. Known treatment with predefined medications, during the last 5 days before screening. Any type of interferon during the last 21 days before screening. Ongoing treatment with immunosuppressants other than guideline recommended immunosuppressants for treatment of active pneumonia. Participation in another interventional clinical trial within 30 days before screening or previous participation in this clinical trial.

Sites / Locations

  • Investigational site # 1010Recruiting
  • Investigational site # 1006Recruiting
  • Investigational site # 1005Recruiting
  • Investigational site # 1001Recruiting
  • Investigational site #5404Recruiting
  • Investigational site # 5407Recruiting
  • Investigational site # 5412Recruiting
  • Investigational site # 5413Recruiting
  • Investigational site # 6102Recruiting
  • Investigational site # 6101Recruiting
  • Investigational site # 4302Recruiting
  • Investigational site # 4301Recruiting
  • Investigational site # 3207Recruiting
  • Investigational site # 3203Recruiting
  • Investigational site # 3206Recruiting
  • Investigational site # 3209Recruiting
  • Investigational site # 3201Recruiting
  • Investigational site # 4202Recruiting
  • Investigational site # 4203Recruiting
  • Investigational site # 4204Recruiting
  • Investigational site # 4201Recruiting
  • Investigational site # 3309Recruiting
  • Investigational site # 3310Recruiting
  • Investigational site # 3303Recruiting
  • Investigational site # 3301Recruiting
  • Investigational site # 3304Recruiting
  • Investigational site # 3312Recruiting
  • Investigational site # 3305Recruiting
  • Investigational site # 3306Recruiting
  • Investigational site # 3308Recruiting
  • Investigational site # 3313Recruiting
  • Investigational site # 4904Recruiting
  • Investigational site # 4905Recruiting
  • Investigational Site # 4903Recruiting
  • Investigational site # 6307Recruiting
  • Investigational site # 6304Recruiting
  • Investigational site # 6301Recruiting
  • Investigational site # 4001Recruiting
  • Investigational site # 4003Recruiting
  • Investigational site # 4002Recruiting
  • Investigational site # 2703Recruiting
  • Investigational site # 2704Recruiting
  • Investigational site # 2705Recruiting
  • Investigational site # 2701Recruiting
  • Investigational Site # 3408Recruiting
  • Investigational site # 3406Recruiting
  • Investigational site # 3407Recruiting
  • Investigational Site # 3405Recruiting
  • Investigational site # 3413Recruiting
  • Investigational site # 3415Recruiting
  • Investigational site # 3410Recruiting
  • Investigational site # 3404Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Trimodulin

Placebo

Arm Description

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

Human albumin 1%

Outcomes

Primary Outcome Measures

28-day all-cause mortality rate
Percentage of subjects that died until day 29 regardless of cause of death

Secondary Outcome Measures

90-day all-cause mortality rate
Percentage of subjects that died until day 91 regardless of cause of death
28-day all-cause mortality rate plus day 6-29 deterioration rate
Percentage of subjects that died until day 29 Percentage of subjects with at least one deterioration event between day 6 and day 29
Deterioration rate (day 6-29)
Percentage of subjects with at least one deterioration event between day 6 and day 29
28-day all-cause mortality rate plus day 1-29 deterioration rate
Percentage of subjects that died until day 29 Percentage of subjects with at least one deterioration event between day 1 and day 29
Deterioration rate (day 1-29)
Percentage of subjects with at least one deterioration event between day 1 and day 29
Change in Sequential Organ Failure Assessment (SOFA) score from baseline to days 3, 5, 7, 14, 21, 29 and discharge
Change in Sequential Organ Failure Assessment (SOFA)
Proportion of subjects with clinical cure of pneumonia on days 7, 14, 21, 29 and discharge
Percentage of subjects with clinical cure of pneumonia
Days of invasive mechanical ventilation (IMV) until day 29
Days of invasive mechanical ventilation (IMV) until day 29
Ventilator-free days (VFD) until day 29
Ventilator-free days (VFD)
Days with oxygen supply until day 29
Days with oxygen supply
Proportion of subjects with oxygen supply on days 7, 14, 21, 29 and discharge
Percentage of subjects with oxygen supply
Proportion of subjects with PaO2/FiO2 ratio < 100, 100 to < 200, 200 to < 300 or ≥ 300 on days 7, 14, 21, and 29
Percentage of subjects with PaO2/FiO2 ratio < 100, 100 to < 200, 200 to < 300 or ≥ 300
Vasopressor-free days until day 29
Vasopressor-free days until day 29
Days in intensive care unit (ICU) until day 29
Days in intensive care unit (ICU) until day 29
Time to discharge from ICU
Time to discharge from ICU
Proportion of subjects in ICU on days 7, 14, 21 and 29
Percentage of subjects in ICU
Days of hospitalization until day 29
Days of hospitalization
Time to discharge from hospital
Time to discharge from hospital
Proportion of subjects in hospital on days 7, 14, 21 and 29
Percentage of subjects in hospital
28-day readmission rate
Percentage of subjects readmitted to the hospital
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
Time to return to normal activities until day 91
Time to return to normal activities
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)
Quality of life based on Nottingham Health Profile (NHP) on days 29 and 91
Change in Quality of life based on Nottingham Health Profile (NHP)
Adverse events (AEs), treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), infusional TEAEs, TEAEs that led to permanent withdrawal 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 withdrawal of IMP, and TEAEs that led to discontinuation of the trial
Infusion-related TEAEs
Number of all infusion-related TEAEs
Serious adverse events (SAEs)
Number, severity, causality, and outcome of all SAEs
Dose modifications
Dose modifications (including reductions and changes in infusion rate)
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
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
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

Full Information

First Posted
January 11, 2023
Last Updated
October 19, 2023
Sponsor
Biotest
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1. Study Identification

Unique Protocol Identification Number
NCT05722938
Brief Title
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
Acronym
ESsCAPE
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
Severe Community-acquired Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized on a 1:1 basis to receive trimodulin or placebo, stratified by center
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All bottles will be indistinguishable.
Allocation
Randomized
Enrollment
590 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trimodulin
Arm Type
Experimental
Arm Description
Trimodulin (human IgM, IgA, IgG solution) for intravenous (IV) administration.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Human albumin 1%
Intervention Type
Drug
Intervention Name(s)
Trimodulin
Other Intervention Name(s)
BT588
Intervention Description
IMP will be administered via IV infusion on 5 consecutive days
Intervention Type
Drug
Intervention Name(s)
Placebo (human albumin 1%)
Intervention Description
IMP will be administered via IV infusion on 5 consecutive days
Primary Outcome Measure Information:
Title
28-day all-cause mortality rate
Description
Percentage of subjects that died until day 29 regardless of cause of death
Time Frame
Between days 1-29
Secondary Outcome Measure Information:
Title
90-day all-cause mortality rate
Description
Percentage of subjects that died until day 91 regardless of cause of death
Time Frame
Between days 1-91
Title
28-day all-cause mortality rate plus day 6-29 deterioration rate
Description
Percentage of subjects that died until day 29 Percentage of subjects with at least one deterioration event between day 6 and day 29
Time Frame
1. Between days 1-29; 2. Between days 6-29
Title
Deterioration rate (day 6-29)
Description
Percentage of subjects with at least one deterioration event between day 6 and day 29
Time Frame
Between days 6-29
Title
28-day all-cause mortality rate plus day 1-29 deterioration rate
Description
Percentage of subjects that died until day 29 Percentage of subjects with at least one deterioration event between day 1 and day 29
Time Frame
1.+2. Between days 1-29
Title
Deterioration rate (day 1-29)
Description
Percentage of subjects with at least one deterioration event between day 1 and day 29
Time Frame
Between days 1-29
Title
Change in Sequential Organ Failure Assessment (SOFA) score from baseline to days 3, 5, 7, 14, 21, 29 and discharge
Description
Change in Sequential Organ Failure Assessment (SOFA)
Time Frame
Between baseline and Days 3, 5, 7, 14, 21, 29 and discharge
Title
Proportion of subjects with clinical cure of pneumonia on days 7, 14, 21, 29 and discharge
Description
Percentage of subjects with clinical cure of pneumonia
Time Frame
On days 7, 14, 21, 29 or on the day of discharge
Title
Days of invasive mechanical ventilation (IMV) until day 29
Description
Days of invasive mechanical ventilation (IMV) until day 29
Time Frame
Until day 29
Title
Ventilator-free days (VFD) until day 29
Description
Ventilator-free days (VFD)
Time Frame
Until day 29
Title
Days with oxygen supply until day 29
Description
Days with oxygen supply
Time Frame
Until day 29
Title
Proportion of subjects with oxygen supply on days 7, 14, 21, 29 and discharge
Description
Percentage of subjects with oxygen supply
Time Frame
On days 7, 14, 21, 29 or on the day of discharge
Title
Proportion of subjects with PaO2/FiO2 ratio < 100, 100 to < 200, 200 to < 300 or ≥ 300 on days 7, 14, 21, and 29
Description
Percentage of subjects with PaO2/FiO2 ratio < 100, 100 to < 200, 200 to < 300 or ≥ 300
Time Frame
On days 7, 14, 21, 29
Title
Vasopressor-free days until day 29
Description
Vasopressor-free days until day 29
Time Frame
Until day 29
Title
Days in intensive care unit (ICU) until day 29
Description
Days in intensive care unit (ICU) until day 29
Time Frame
Until day 29
Title
Time to discharge from ICU
Description
Time to discharge from ICU
Time Frame
Until day 91
Title
Proportion of subjects in ICU on days 7, 14, 21 and 29
Description
Percentage of subjects in ICU
Time Frame
On days 7, 14, 21, 29
Title
Days of hospitalization until day 29
Description
Days of hospitalization
Time Frame
Until day 29
Title
Time to discharge from hospital
Description
Time to discharge from hospital
Time Frame
Until day 91
Title
Proportion of subjects in hospital on days 7, 14, 21 and 29
Description
Percentage of subjects in hospital
Time Frame
On days 7, 14, 21, 29
Title
28-day readmission rate
Description
Percentage of subjects readmitted to the hospital
Time Frame
Day 29
Title
Rate of unscheduled return(s) to the emergency department or primary physician between day 29 and day 91
Description
Percentage of subjects returning to the emergency department or primary physician
Time Frame
Between Days 29 - 91
Title
Time to return to normal activities until day 91
Description
Time to return to normal activities
Time Frame
Until day 91
Title
Health status based on Clinical Frailty Scale (CFS) on day 91
Description
Change in Health status from Baseline assessment based on Clinical Frailty Scale (score 1 very fit to score 9 terminally ill)
Time Frame
Between Days 29 - 91
Title
Quality of life based on Nottingham Health Profile (NHP) on days 29 and 91
Description
Change in Quality of life based on Nottingham Health Profile (NHP)
Time Frame
Day 29 and day 91
Title
Adverse events (AEs), treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), infusional TEAEs, TEAEs that led to permanent withdrawal of IMP and/or discontinuation of trial
Description
Number, severity, causality, outcome, and seriousness of all AEs and TEAEs, AESIs, infusional TEAEs, TEAEs that led to permanent withdrawal of IMP, and TEAEs that led to discontinuation of the trial
Time Frame
Until day 29
Title
Infusion-related TEAEs
Description
Number of all infusion-related TEAEs
Time Frame
Until day 29
Title
Serious adverse events (SAEs)
Description
Number, severity, causality, and outcome of all SAEs
Time Frame
Until day 29
Title
Dose modifications
Description
Dose modifications (including reductions and changes in infusion rate)
Time Frame
Day 1-5
Title
Change over time in electrocardiogram (ECG) parameters
Description
ECG output (diagram including QT-interval and QTcF) showing abnormal, clinically relevant findings will be reported as adverse event
Time Frame
Days -1, 1, 3, 5 and once between days 8-13
Title
Number and changes in observed Adverse Events in vital signs over time
Description
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
Time Frame
Days -1, 1-3, 5, 7, 14, 21, 29
Title
Number and changes in observed Adverse Events in clinical laboratory parameters over time
Description
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
Time Frame
Days -1, 1-5, 7, 14, 21, 29
Other Pre-specified Outcome Measures:
Title
Serum concentration of immunoglobulins
Description
Changes of serum concentration of IgM, IgA, and IgG from baseline, during and after treatment
Time Frame
Day 1, 5, 14
Title
Pharmacokinetic assessment of immunoglobulins
Description
Assessment of changes in serum concentrations (g/L) of IgM, IgA, and IgG before, during and after treatment
Time Frame
Day 1, 2, 3, 4, 5, 6, 7, 9, 14, 21, 29
Title
Pharmacodynamic assessment of disease related serum proteins
Description
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)
Time Frame
Day 1, 2, 3, 4, 5, 7, 14, 21, 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Written informed consent. Hospitalized, adult (≥ 18 years of age) subject. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) negative status. Signs of inflammation based on C-reactive protein threshold level. Diagnosis of active pneumonia. 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 not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment. Suspected hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP). Diagnosis of COVID-19 during the last 4 weeks. Subjects that required oxygen therapy due to COVID-19 in the last 6 months. Defined neutrophil counts within 24 hours prior to start of IMP treatment. Defined platelet counts within 24 hours prior to start of IMP treatment. Defined hemoglobin within 24 hours prior to start of IMP treatment. Known hemolytic disease. Known thrombosis or thromboembolic events (TEEs) or known medical history of TEEs or subjects particularly at risk for TEEs. Subject on dialysis or with severe renal impairment within 24 hours prior to start of IMP treatment. Subject with end-stage renal disease (ESRD) or known primary focal segmental glomerulosclerosis (FSGS). Known severe lung diseases interfering with sCAP therapy (e.g., subjects with chronic obstructive pulmonary disease [COPD], severe interstitial lung disease [incl. idiopathic pulmonary fibrosis], cystic fibrosis, active tuberculosis, chronically infected bronchiectasis, or active lung cancer). Known decompensated heart failure. Known pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh score ≥ 9 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. Known treatment for thorax/head/neck/hematologic malignancies in the last 12 months before screening. 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. Known treatment with polyvalent immunoglobulin preparations, plasma, or albumin preparations during the last 21 days before screening. Known treatment with predefined medications, during the last 5 days before screening. Any type of interferon during the last 21 days before screening. Ongoing treatment with immunosuppressants other than guideline recommended immunosuppressants for treatment of active pneumonia. Participation in another interventional clinical trial within 30 days before screening or previous participation in this clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iris Bobenhausen, PhD
Phone
+4915222801073
Email
iris.bobenhausen@biotest.com
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Schulte
Phone
+4915222801491
Email
claudia.schulte@biotest.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Welte, Prof.
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigational site # 1010
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational site # 1006
City
Hannibal
State/Province
Missouri
ZIP/Postal Code
63401
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational site # 1005
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational site # 1001
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational site #5404
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1039AAO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational site # 5407
City
Ciudad Autonoma de Buenos Aire
ZIP/Postal Code
C1430EGF
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational site # 5412
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational site # 5413
City
San Nicolas
ZIP/Postal Code
2900
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational site # 6102
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational site # 6101
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational site # 4302
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Investigational site # 4301
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Investigational site # 3207
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational site # 3203
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational site # 3206
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational site # 3209
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational site # 3201
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Investigational site # 4202
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Investigational site # 4203
City
Kolín
ZIP/Postal Code
28002
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Investigational site # 4204
City
Kyjov
ZIP/Postal Code
69701
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Investigational site # 4201
City
Prague
ZIP/Postal Code
10034
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Investigational site # 3309
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational site # 3310
City
Colombes
ZIP/Postal Code
92700
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational site # 3303
City
Melun
ZIP/Postal Code
77000
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational site # 3301
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational site # 3304
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational site # 3312
City
Paris
ZIP/Postal Code
75679
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational site # 3305
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational site # 3306
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational site # 3308
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational site # 3313
City
Toulon
ZIP/Postal Code
83056
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational site # 4904
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational site # 4905
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site # 4903
City
Hanover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational site # 6307
City
Caloocan
ZIP/Postal Code
1427
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Investigational site # 6304
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Investigational site # 6301
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Investigational site # 4001
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational site # 4003
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational site # 4002
City
Timişoara
ZIP/Postal Code
300723
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational site # 2703
City
Johannesburg
ZIP/Postal Code
1500
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational site # 2704
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational site # 2705
City
Pretoria
ZIP/Postal Code
0184
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational site # 2701
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site # 3408
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational site # 3406
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational site # 3407
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site # 3405
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational site # 3413
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational site # 3415
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational site # 3410
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational site # 3404
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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