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.
Who can participate
Age range18 Years
SexALL
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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.
Exclusion criteria
✕. Pregnant or lactating women.
✕. Subject on invasive mechanical ventilation and/or extracorporeal membrane oxygenation.
✕. Subject with septic shock and in need for vasopressors.