COVID-19 Clinical Trial
— TRICOVIDOfficial title:
A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase III Trial to Assess the Efficacy and Safety of Trimodulin (BT588) in Adult Hospitalized Subjects With CAP Including COVID-19 Pneumonia.
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Biotest |
Argentina, Austria, Belgium, Brazil, France, Germany, Hungary, Latvia, Lithuania, Portugal, Slovakia, South Africa, Spain, Turkey,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
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