Study to assess efficacy and safety of DFV890 in patients with COVID-19 pneumonia and impaired respiratory function

INTERVENTION: Product Name: DFV890 Product Code: DFV890 Pharmaceutical Form: Tablet INN or Proposed INN: Not yet established Current Sponsor code: DFV890 Other descriptive name: IFM‐2427 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ CONDITION: COVID‐19 pneumonia and impaired respiratory function ; MedDRA version: 20.0 Level: LLT Classification code 10061986 Term: SARS System Organ Class: 100000004862 Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: Evaluate the effect of DFV890 in addition to SoC, compared with SoC alone on the Acute Physiology and Chronic Health Evaluation II (APACHE II) score Primary end point(s): Evaluate the effect of DFV890 in addition to SoC, compared with SoC alone on the Acute Physiology and Chronic Health Evaluation II (APACHE II) score Secondary Objective: • To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on inflammatory status; • To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on clinical status ; • To evaluate the safety of DFV890 in addition to SoC, compared with SoC alone ; ; Timepoint(s) of evaluation of this end point: Day 15 or on day of discharge (whichever is earlier) SECONDARY OUTCOME: Secondary end point(s): • To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on inflammatory status ; •To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on clinical status ; •To evaluate the safety of DFV890 in addition to SoC, compared with SoC alone ; ; Timepoint(s) of evaluation of this end point: Up to day 29 after first dose INCLUSION CRITERIA: • Clinically diagnosed with the SARS‐CoV‐2 virus • Hospitalized with COVID‐19‐induced pneumonia • Impaired respiratory function, defined as peripheral oxygen saturation (SpO2) =93% on room air or partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) <300 millimeter of mercury (mmHg) • APACHE II score of =10 at time of randomization • C‐reactive protein (CRP) =20 mg/L and/or ferritin level =600 µg/L • Body weight mass index of =18 to <40kg/m2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60