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| Column | Value |
|---|---|
| Trial registration number | NCT05531149 |
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Full text link
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
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First author
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
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Contact
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
patrick.langohr@biotest.com |
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Registration date
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
2022-09-07 |
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Recruitment status
Last imported at : Dec. 24, 2022, 4 p.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Dec. 24, 2022, 4 p.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Nov. 19, 2023, noon Source : ClinicalTrials.gov |
main inclusion criteria: 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. main |
|
Exclusion criteria
Last imported at : Nov. 19, 2023, noon Source : ClinicalTrials.gov |
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. life expectancy of less than 90 days. morbid obesity or malnutrition. treatment with predefined medications (certain immune modulators or immunosuppressants) before entering the trial. |
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Number of arms
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
Biotest |
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Inclusion age min
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : April 13, 2024, 8 a.m. Source : ClinicalTrials.gov |
Argentina;Austria;Belgium;Brazil;France;Germany;Hungary;Latvia;Lithuania;Portugal;Slovakia;South Africa;Spain;Turkey |
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Type of patients
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
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Severity scale
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
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Total sample size
Last imported at : Nov. 19, 2023, noon Source : ClinicalTrials.gov |
390 |
|
primary outcome
Last imported at : Nov. 19, 2023, noon Source : ClinicalTrials.gov |
Composite Endpoint |
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Notes
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Sept. 9, 2022, midnight Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 1319, "treatment_name": "Trimodulin", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |