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

NCT ID: NCT05531149

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-22
• Study Completion Date: 2025-05-05

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.

Detailed Description

This is a randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin compared to placebo treatment, adjunctive to SoC in adult hospitalized subjects with non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia. Patients requiring low-flow oxygen, non-invasive ventilation or high-flow oxygen and with signs of early systemic inflammation (defined by C reactive protein (CRP), D-dimer and platelet levels) will be enrolled.

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. Investigational Medicinal Product (IMP) treatments will be blinded. Subjects will be administered IMP once daily on five 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 all subjects still in the hospital after day 29, an extended follow-up visit is conducted until day 90 or until discharge. For all subjects a closing visit/telephone call on day 91 [+10] will be done.

For the evaluation of the primary and several secondary endpoints of the trial, a 9-category ordinal scale will be used. The primary objective is to assess efficacy of trimodulin based on clinical deterioration and mortality to demonstrate superiority to treatment with placebo. Secondary objectives are to assess efficacy and safety and to determine PK and PD properties of trimodulin compared to placebo.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Trimodulin

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

Group Type: EXPERIMENTAL

Trimodulin

Intervention Type: DRUG

IMP will be administered via IV infusion on 5 consecutive days

Placebo

Human albumin 1%

Group Type: PLACEBO_COMPARATOR

Placebo (human albumin 1%)

Intervention Type: DRUG

IMP will be administered via IV infusion on 5 consecutive days

Interventions

Trimodulin

IMP will be administered via IV infusion on 5 consecutive days

Intervention Type: DRUG

Placebo (human albumin 1%)

IMP will be administered via IV infusion on 5 consecutive days

Intervention Type: DRUG

Other Intervention Names

BT588

Eligibility Criteria

Inclusion Criteria

1. Written informed consent.

2. Hospitalized, adult (≥ 18 years of age) subjects.

3. 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.

4. Receiving oxygen supply via low-flow oxygen, high-flow oxygen or on non-invasive ventilation.

5. Fulfilling at least one clinical respiratory parameter (SpO2 ≤ 94% and/or 100 mm Hg < PaO2/FiO2 ≤ 300 mm Hg).

6. Signs of early systemic inflammation based on CRP and coagulation parameter threshold levels.

Exclusion Criteria

1. Pregnant or lactating women.

2. Subject on invasive mechanical ventilation and/or extracorporeal membrane oxygenation.

3. Subject with septic shock and in need for vasopressors.

4. Severe neutropenia prior to start of treatment.

5. Hemoglobin >7 g/dL prior to start of treatment.

6. Pre-existing hemolytic disease.

7. Pre-existing thromboembolic events (TEEs).

8. Subject on dialysis or with severe renal impairment prior to start of treatment.

9. Subject with end stage renal disease, or known primary focal segmental glomerulosclerosis.

10. Pre-existing severe lung diseases to current pneumonia.

11. Pre-existing decompensated heart failure.

12. Pre-existing hepatic cirrhosis, severe hepatic impairment , or hepatocellular carcinoma.

13. Known intolerance to proteins of human origin or known allergic reactions to components of trimodulin/placebo.

14. Selective, absolute immunoglobulin A (IgA) deficiency with known antibodies to IgA.

15. Known human immunodeficiency virus infection.

16. Life expectancy of less than 90 days.

17. Morbid obesity or malnutrition.

18. Treatment with predefined medications (certain immune modulators or immunosuppressants) before entering the trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotest

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoni Torres, Prof

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic de Barcelona, Barcelona, Spain

Locations

Investigational Site #5401

Buenos Aires, , Argentina

Investigational Site #5403

Córdoba, , Argentina

Investigational Site #5402

Córdoba, , Argentina

Investigational Site #4303

Klagenfurt, , Austria

Investigational Site #4302

Linz, , Austria

Investigational Site #4304

Vienna, , Austria

Investigational Site #3203

Edegem, , Belgium

Investigational Site #3202

Mechelen, , Belgium

Investigational Site #3201

Ottignies, , Belgium

Investigational Site #5508

Campo Largo, São Paulo, Brazil

Investigational Site #5509

Ribeirão Preto, São Paulo, Brazil

Investigational Site #5511

São Paulo, São Paulo, Brazil

Investigational Site #5505

Botucatu, , Brazil

Investigational Site #5503

Porto Alegre, , Brazil

Investigational Site #5507

Porto Alegre, , Brazil

Investigational Site #5506

Porto Alegre, , Brazil

Investigational Site #5502

Santo André, , Brazil

Investigational Site #5510

Santos, , Brazil

Investigational Site #5504

São José do Rio Preto, , Brazil

Investigational Site #5501

São Paulo, , Brazil

Investigational Site #3303

Melun, , France

Investigational Site #3304

Paris, , France

Investigational Site #3301

Paris, , France

Investigational Site #3305

Saint-Etienne, , France

Investigational Site #3307

Salouël, , France

Investigational Site #3306

Strasbourg, , France

Investigational Site #3308

Strasbourg, , France

Investigational Site #3302

Trévenans, , France

Investigational Site #4904

Berlin, , Germany

Investigational Site #4901

Bochum, , Germany

Investogational Site #4902

Cottbus, , Germany

Investigational Site #4903

Hanover, , Germany

Investigational Site #4907

München, , Germany

Investigational SIte #3603

Debrecen, , Hungary

Investigational Site #3601

Szeged, , Hungary

Investigational Site #7102

Daugavpils, , Latvia

Investigational Site #7101

Riga, , Latvia

Investigational Site #7002

Kaunas, , Lithuania

Investigational Site #7007

Kaunas, , Lithuania

Investigational Site #7005

Kaunas, , Lithuania

Investigational Site #7003

Klaipėda, , Lithuania

Investigational Site #7004

Šiauliai, , Lithuania

Investigational Site #7006

Vilnius, , Lithuania

Investigational Site #7001

Vilnius, , Lithuania

Investigational Site #3502

Guimarães, , Portugal

Investogational SIte #3501

Lisbon, , Portugal

Investigational Site #2103

Banská Bystrica, , Slovakia

Investigational Site #2102

Malacky, , Slovakia

Investigational Site #2105

Michalovce, , Slovakia

Investigational Site #2101

Nitra, , Slovakia

Investigational Site #2104

Svidník, , Slovakia

Investigational site #2706

Kimberley, , South Africa

Investigational Site #2702

Klerksdorp, , South Africa

Investigational Site #2703

Mthatha, , South Africa

Investigational Site #2705

Plettenberg Bay, , South Africa

Investigational Site #2701

Pretoria, , South Africa

Investigational Site #2707

Pretoria, , South Africa

Investigational Site #2704

Pretoria, , South Africa

Investigational Site #3401

Barcelona, , Spain

Investigational Site #3403

Madrid, , Spain

Investigational Site #3404

Madrona, , Spain

Investigational Site #9005

Ankara, , Turkey (Türkiye)

Investigational Site #9004

Istanbul, , Turkey (Türkiye)

Investigational Site #9001

Trabzon, , Turkey (Türkiye)

Countries

Argentina; Austria; Belgium; Brazil; France; Germany; Hungary; Latvia; Lithuania; Portugal; Slovakia; South Africa; Spain; Turkey (Türkiye)

Other Identifiers

1001

Identifier Type: -

Identifier Source: org_study_id