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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05531149
Other study ID # 1001
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 22, 2022
Est. completion date August 31, 2025

Study information

Verified date April 2024
Source Biotest
Contact Patrick Langohr
Phone +491732947122
Email patrick.langohr@biotest.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 390
Est. completion date August 31, 2025
Est. primary completion date August 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Main 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. Main 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.

Study Design


Intervention

Drug:
Trimodulin
IMP will be administered via IV infusion on 5 consecutive days
Placebo (human albumin 1%)
IMP will be administered via IV infusion on 5 consecutive days

Locations

Country Name City State
Argentina Investigational Site #5401 Buenos Aires
Argentina Investigational Site #5403 Cordoba
Argentina Investigational Site #5402 Córdoba
Austria Investigational Site #4303 Klagenfurt
Austria Investigational Site #4302 Linz
Austria Investigational Site #4304 Wien
Belgium Investigational Site #3203 Edegem
Belgium Investigational Site #3202 Mechelen
Belgium Investigational Site #3201 Ottignies
Brazil Investigational Site #5505 Botucatu
Brazil Investigational Site #5503 Porto Alegre
Brazil Investigational Site #5506 Porto Alegre
Brazil Investigational Site #5507 Porto Alegre
Brazil Investigational Site #5502 Santo André
Brazil Investigational Site #5504 São José Do Rio Preto
Brazil Investigational Site #5501 São Paulo
France Investigational Site #3303 Melun
France Investigational Site #3301 Paris
France Investigational Site #3304 Paris
France Investigational Site #3305 Saint-Étienne
France Investigational Site #3307 Salouël
France Investigational Site #3306 Strasbourg
France Investigational Site #3308 Strasbourg
France Investigational Site #3302 Trévenans
Germany Investigational Site #4904 Berlin
Germany Investigational Site #4901 Bochum
Germany Investogational Site #4902 Cottbus
Germany Investigational Site #4903 Hannover
Germany Investigational Site #4907 München
Hungary Investigational SIte #3603 Debrecen
Hungary Investigational Site #3601 Szeged
Latvia Investigational Site #7102 Daugavpils
Latvia Investigational Site #7101 Riga
Lithuania Investigational Site #7004 Šiauliai
Lithuania Investigational Site #7002 Kaunas
Lithuania Investigational Site #7005 Kaunas
Lithuania Investigational Site #7007 Kaunas
Lithuania Investigational Site #7003 Klaipeda
Lithuania Investigational Site #7001 Vilnius
Portugal Investigational Site #3502 Guimarães
Portugal Investogational SIte #3501 Lisboa
Slovakia 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
South Africa 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 #2704 Pretoria
South Africa Investigational Site #2707 Pretoria
Spain Investigational Site #3401 Barcelona
Spain Investigational Site #3403 Madrid
Spain Investigational Site #3404 Madrona
Turkey Investigational Site #9005 Ankara
Turkey Investigational Site #9004 Istanbul
Turkey Investigational Site #9001 Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Biotest

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Brazil,  France,  Germany,  Hungary,  Latvia,  Lithuania,  Portugal,  Slovakia,  South Africa,  Spain,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Pharmacokinetic assessment of immunoglobulins Assessment of changes in serum concentrations (g/L) of immunoglobulin M (IgM), immunoglobulin A (IgA), and immunoglobulin G (IgG) before, during and after treatment Day 1, 5, 14
Other Pharmacodynamic assessment of disease related serum proteins Assessment of relative changes in serum concentrations from baseline before, during and after treatment including markers of inflammation, coagulation, complement factors and biomarkers (e.g. % change in Interleukin-6) Days 1, 3, 5, 7, 14
Primary 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 Clinical deterioration rate Percentage of subjects with a change of at least 1 category on the category ordinal-scale Between days 6-29 and days 1-29
Secondary 28-days all-cause mortality rate Percentage of subjects with a change to 8 on 9-category ordinal scale. Day 29
Secondary 90-days all-cause mortality rate Percentage of subjects with a change to 8 on 9-category ordinal scale. Day 91
Secondary Time to recovery Number of days to score = 2 until day 29 Between days 1-29
Secondary Proportion of subjects with score = 2 Proportion of subjects that improved to score = 2 Day 29
Secondary Proportion of subjects improved, unchanged, and deteriorated/died Proportion of subjects improved, unchanged, and deteriorated/died compared to baseline at several days Between days 1-29
Secondary Proportion of subjects with different partial pressure of oxygen (PaO2)/ fraction of inspired oxygen (FiO2) ratios Proportion of subjects with PaO2/FiO2 ratio < 100, 100 to < 200, 200 to < 300 or = 300 Days 7, 14, 21, 29
Secondary Days of invasive mechanical ventilation (IMV)/ extracorporeal membrane oxygenation (ECMO) Days of IMV/ECMO Day 29
Secondary Proportion of subjects on IMV/ECMO Proportion of subjects on IMV/ECMO Day 29
Secondary Days with oxygen supply Days with oxygen supply Day 29
Secondary Proportion of subjects with oxygen supply Proportion of subjects with oxygen supply Days 7, 14, 21, 29
Secondary Days in intensive care unit (ICU) Days in intensive care unit Day 29
Secondary Proportion of subjects in ICU Proportion of subjects in ICU Day 29
Secondary Days of hospitalization Days of hospitalization Day 29
Secondary All 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 adverse events (AEs), treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), infusional TEAEs, TEAEs that led to permanent withdrawal of IMP, and TEAEs that led to discontinuation of the trial Until day 29
Secondary TEAEs Number of all related TEAEs Until day 29
Secondary SAEs Number, severity, causality, and outcome of all serious adverse events (SAEs) Until day 29
Secondary Dose modifications Dose modifications (incl. reductions and changes in infusion rate) Day 1-5
Secondary Change over time in ECG parameters ECG recordings, (including heart rate, QT-interval, QTcF) showing abnormal, clinically relevant findings will be reported as adverse event Days -1, 1, 3, 5 and once between days 8-13
Secondary Changes over time in vital signs Changes in recordings of vital sign parameters showing clinically significant measurements outside the normal range will be reported as adverse event. Days -1,1-3, 5, 7 ,14, 21, 29
Secondary Changes over time in clinical laboratory parameters Changes in recordings for clinical laboratory values (including chemistry, hematology and coagulation) showing clinically significant measurements outside the normal range will be reported as adverse event. Days -1, 1-5, 7,14, 21, 29
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