Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia

NCT05531149 | Terminated Phase 3 DMC

• 1 other identifier: 1001
• Study Type: interventional
• Target: 107
• Locations: 14 countries
• Sites: 64

Brief Summary

The main objectives of the trial are 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 non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia. Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin.

Conditions

Respiratory Infection; Pneumonia; Community-acquired Pneumonia; Acute Respiratory Distress Syndrome; COVID-19; Viral Pneumonia; Bacterial Pneumonia; Fungal Pneumonia

Keywords

Non severe community acquired pneumonia; COVID-19; SARS-CoV-2; CAP

Outcome Measures

Primary Outcomes (1)

• Composite Endpoint

  Composite of percentage of subjects with a change of at least 1 category on the 9-category ordinal scale from baseline (between days 6-29) and 28-day all-cause mortality rate (between days 1-29)

  Until day 29

Secondary Outcomes (21)

• Clinical deterioration rate

  Between days 6-29 and days 1-29

• 28-days all-cause mortality rate

  Day 29

• 90-days all-cause mortality rate

  Day 91

• Time to recovery

  Between days 1-29

• Proportion of subjects with score ≤ 2

  Day 29

Other Outcomes (2)

• Pharmacokinetic assessment of immunoglobulins

  Day 1, 5, 14

• Pharmacodynamic assessment of disease related serum proteins

  Days 1, 3, 5, 7, 14

Study Arms (2)

Trimodulin

EXPERIMENTAL

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

Drug: Trimodulin

Placebo

PLACEBO COMPARATOR

Human albumin 1%

Drug: Placebo (human albumin 1%)

Interventions

Trimodulin DRUG

IMP will be administered via IV infusion on 5 consecutive days

Also known as: BT588

Trimodulin

Placebo (human albumin 1%) DRUG

IMP will be administered via IV infusion on 5 consecutive days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Hospitalized, adult (≥ 18 years of age) subjects.
• Diagnosis of CAP or COVID- 19 pneumonia (e.g. according to local guidelines) and with radiologic evidence showing new pulmonary lobar or multilobar infiltrates consistent with CAP or COVID-19 pneumonia.
• Receiving oxygen supply via low-flow oxygen, high-flow oxygen or on non-invasive ventilation.
• Fulfilling at least one clinical respiratory parameter (SpO2 ≤ 94% and/or 100 mm Hg \< PaO2/FiO2 ≤ 300 mm Hg).
• Signs of early systemic inflammation based on CRP and coagulation parameter threshold levels.

You may not qualify if:

• Pregnant or lactating women.
• Subject on invasive mechanical ventilation and/or extracorporeal membrane oxygenation.
• Subject with septic shock and in need for vasopressors.
• Severe neutropenia prior to start of treatment.
• Hemoglobin \>7 g/dL prior to start of treatment.
• Pre-existing hemolytic disease.
• Pre-existing thromboembolic events (TEEs).
• Subject on dialysis or with severe renal impairment prior to start of treatment.
• Subject with end stage renal disease, or known primary focal segmental glomerulosclerosis.
• Pre-existing severe lung diseases to current pneumonia.
• Pre-existing decompensated heart failure.
• Pre-existing hepatic cirrhosis, severe hepatic impairment , or hepatocellular carcinoma.
• Known intolerance to proteins of human origin or known allergic reactions to components of trimodulin/placebo.
• Selective, absolute immunoglobulin A (IgA) deficiency with known antibodies to IgA.
• Known human immunodeficiency virus infection.

Sponsors & Collaborators

• Biotest: lead

Study Sites (64)

Investigational Site #5401

Buenos Aires, 1602, Argentina

Location

Investigational Site #5403

Córdoba, 5000, Argentina

Location

Investigational Site #5402

Córdoba, X5021FPQ, Argentina

Location

Investigational Site #4303

Klagenfurt, 9020, Austria

Location

Investigational Site #4302

Linz, 4020, Austria

Location

Investigational Site #4304

Vienna, 1090, Austria

Location

Investigational Site #3203

Edegem, 2650, Belgium

Location

Investigational Site #3202

Mechelen, 2800, Belgium

Location

Investigational Site #3201

Ottignies, 1340, Belgium

Location

Investigational Site #5508

Campo Largo, São Paulo, 83606-177, Brazil

Location

Investigational Site #5509

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Investigational Site #5511

São Paulo, São Paulo, 01323-903, Brazil

Location

Investigational Site #5505

Botucatu, 18618-686, Brazil

Location

Investigational Site #5503

Porto Alegre, 90020-090, Brazil

Location

Investigational Site #5507

Porto Alegre, 90035-903, Brazil

Location

Investigational Site #5506

Porto Alegre, 90610-000, Brazil

Location

Investigational Site #5502

Santo André, 09030-10, Brazil

Location

Investigational Site #5510

Santos, 11075-101, Brazil

Location

Investigational Site #5504

São José do Rio Preto, 15090-000, Brazil

Location

Investigational Site #5501

São Paulo, 09530-700, Brazil

Location

Investigational Site #3303

Melun, 77000, France

Location

Investigational Site #3304

Paris, 75020, France

Location

Investigational Site #3301

Paris, 75877, France

Location

Investigational Site #3305

Saint-Etienne, 42055, France

Location

Investigational Site #3307

Salouël, 80054, France

Location

Investigational Site #3306

Strasbourg, 67091, France

Location

Investigational Site #3308

Strasbourg, 67098, France

Location

Investigational Site #3302

Trévenans, 90400, France

Location

Investigational Site #4904

Berlin, 10117, Germany

Location

Investigational Site #4901

Bochum, 44892, Germany

Location

Investogational Site #4902

Cottbus, 03048, Germany

Location

Investigational Site #4903

Hanover, 30625, Germany

Location

Investigational Site #4907

München, 81377, Germany

Location

Investigational SIte #3603

Debrecen, 4031, Hungary

Location

Investigational Site #3601

Szeged, 6725, Hungary

Location

Investigational Site #7102

Daugavpils, LV-5417, Latvia

Location

Investigational Site #7101

Riga, LV-1002, Latvia

Location

Investigational Site #7002

Kaunas, 47116, Lithuania

Location

Investigational Site #7007

Kaunas, LT-44320, Lithuania

Location

Investigational Site #7005

Kaunas, LT-50161, Lithuania

Location

Investigational Site #7003

Klaipėda, LT-92288, Lithuania

Location

Investigational Site #7004

Šiauliai, LT-76231, Lithuania

Location

Investigational Site #7006

Vilnius, 08661, Lithuania

Location

Investigational Site #7001

Vilnius, LT-08406, Lithuania

Location

Investigational Site #3502

Guimarães, 4835-044, Portugal

Location

Investogational SIte #3501

Lisbon, 1500-650, Portugal

Location

Investigational Site #2103

Banská Bystrica, 97517, Slovakia

Location

Investigational Site #2102

Malacky, 90122, Slovakia

Location

Investigational Site #2105

Michalovce, 07101, Slovakia

Location

Investigational Site #2101

Nitra, 95991, Slovakia

Location

Investigational Site #2104

Svidník, 08901, Slovakia

Location

Investigational site #2706

Kimberley, 8301, South Africa

Location

Investigational Site #2702

Klerksdorp, 1864, South Africa

Location

Investigational Site #2703

Mthatha, 5100, South Africa

Location

Investigational Site #2705

Plettenberg Bay, 6600, South Africa

Location

Investigational Site #2701

Pretoria, 0001, South Africa

Location

Investigational Site #2707

Pretoria, 0002, South Africa

Location

Investigational Site #2704

Pretoria, 0204, South Africa

Location

Investigational Site #3401

Barcelona, 08036, Spain

Location

Investigational Site #3403

Madrid, 28040, Spain

Location

Investigational Site #3404

Madrona, 28222, Spain

Location

Investigational Site #9005

Ankara, 06800, Turkey (Türkiye)

Location

Investigational Site #9004

Istanbul, 34303, Turkey (Türkiye)

Location

Investigational Site #9001

Trabzon, 61100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Pneumonia; Community-Acquired Pneumonia; Respiratory Distress Syndrome; COVID-19; Pneumonia, Viral; Pneumonia, Bacterial

Interventions

trimodulin

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Lung Diseases; Community-Acquired Infections; Respiration Disorders; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Antoni Torres, Prof

  Hospital Clinic de Barcelona, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All bottles will be indistinguishable.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to receive either trimodulin or placebo on a 1:1 basis, stratified by type of oxygen supply before randomization and by region

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: September 7, 2022
• Study Start: December 22, 2022
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2); SL (5); LI (7); BE (3); AR (3); LA (2); ES (3); TU (3); AU (3); DE (5); HU (2); ZA (7); BR (11); FR (8)