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Recruiting Phase 3 Interventional

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 Sep 1, 2026, 11:56 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

Interventions

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 8, 2023
Primary completion
Jul 30, 2028
Completion
Jul 30, 2028
Last update posted
Jul 23, 2026

2023 – 2028

United States locations

U.S. sites
19
U.S. states
14
U.S. cities
19
Facility City State ZIP Site status
Pulmonary Associates of Mobile, P.C. Mobile Alabama 36608 Withdrawn
University of California San Francisco-Fresno Fresno California 93701 Recruiting
UC Davis Health Sacramento California 95817 Withdrawn
Augusta University Augusta Georgia 30912 Withdrawn
Sparrow Clinical Research Institute Lansing Michigan 48912 Withdrawn
William Beaumont Hospital Royal Oak Michigan 48073 Withdrawn
University of Missouri Clinical Research Center Columbia Missouri 65212 Withdrawn
Hannibal Clinic Hannibal Missouri 63401 Withdrawn
Mercury Street Medical Group Butte Montana 59701 Withdrawn
St. Michael's Medical Center Newark New Jersey 07102 Withdrawn
Buffalo VA Medical Center Buffalo New York 14215 Withdrawn
Lenox Hill Hospital New York New York 10075-1850 Recruiting
Wake Forest Baptist Winston-Salem North Carolina 27157 Recruiting
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 Withdrawn
Jefferson University Hospitals Philadelphia Pennsylvania 19107 Withdrawn
Vanderbilt University Medical Center Nashville Tennessee 37232 Withdrawn
Medical City Fort Worth Fort Worth Texas 76104 Withdrawn
Houston Methodist Hospital Houston Texas 77030 Recruiting
University of Utah Salt Lake City Utah 84108 Recruiting

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 135 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 Jul 23, 2026 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05722938 live on ClinicalTrials.gov.

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