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

ClinicalTrials.gov ID: NCT05722938

Public ClinicalTrials.gov record NCT05722938. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 19, 2026, 1:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT05722938
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Biotest; Industry
Enrollment: 590 participants

Conditions and interventions

Conditions

Community-acquired Pneumonia

Interventions

Trimodulin Drug
Placebo (human albumin 1%) Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 9, 2023 (Actual)
Primary completion: Jul 31, 2028 (Estimated)
Completion: Jul 31, 2028 (Estimated)
Last update posted: Sep 14, 2026

2023 – 2028

United States locations

U.S. sites: 29
U.S. states: 18
U.S. cities: 26

Facility	City	State	ZIP	Site status
#1012 Pulmonary Associates of Mobile, P.C.	Mobile	Alabama	36608	Withdrawn
# 1033 Banner University Medical Center	Phoenix	Arizona	85006	Not yet recruiting
#1007 University of California San Francisco-Fresno	Fresno	California	93701	Recruiting
# 1015 UC Davis Health	Sacramento	California	95817	Withdrawn
# 1002 Augusta University	Augusta	Georgia	30912	Withdrawn
# 1028 University of Maryland, Baltimore	Baltimore	Maryland	21201	Not yet recruiting
# 1034 Brigham and Women's Hospital	Boston	Massachusetts	02115	Not yet recruiting
# 1010 Sparrow Clinical Research Institute Site 1010	Lansing	Michigan	48912	Withdrawn
# 1003 William Beaumont Hospital	Royal Oak	Michigan	48073	Withdrawn
#1009 University of Missouri Clinical Research Center	Columbia	Missouri	65212	Withdrawn
# 1006 Hannibal Clinic	Hannibal	Missouri	63401	Withdrawn
# 1005 Mercury Street Medical Group	Butte	Montana	59701	Withdrawn
# 1001 St. Michael's Medical Center	Newark	New Jersey	07102	Withdrawn
# 1011 Buffalo VA Medical Center	Buffalo	New York	14215	Withdrawn
# 1021 Northern Westchester Hospital	Mount Kisco	New York	10549	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	Not yet recruiting
# 1017 Wake Forest Baptist	Winston-Salem	North Carolina	27157	Recruiting
# 1025 University of Cincinnati College of Medicine	Cincinnati	Ohio	45267	Not yet recruiting
# 1004 Ohio State University Wexner Medical Center	Columbus	Ohio	43210	Active, not recruiting
# 1013 University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	73104	Withdrawn
# 1016 Jefferson University Hospitals	Philadelphia	Pennsylvania	19107	Withdrawn
# 1018 Vanderbilt University Medical Cente	Nashville	Tennessee	37232	Withdrawn
# 1020 Medical City Fort Worth	Fort Worth	Texas	76104	Withdrawn
# 1022 Houston Methodist Hospital	Houston	Texas	77030	Not yet recruiting
# 1026 Intermountain Medical Center	Murray	Utah	84107	Not yet recruiting
# 1019 University of Utah	Salt Lake City	Utah	84108	Withdrawn

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 140 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05722938, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 14, 2026 · Synced Oct 19, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05722938 live on ClinicalTrials.gov.

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