ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: BI 764198; Placebo
Intervention description: BI 764198; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 133.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study is open to adults with COVID-19 infection who are in hospital and receive oxygen.
      Participants need to be 50 years of age or older and need to be at risk of further worsening
      of their condition.

      The purpose of the study is to find out whether a medicine called BI 764198 helps people with
      COVID-19 infection and breathing problems. BI 764198 may prevent cell death and swelling of
      the lung tissue and therefore help patients with COVID-19 infection.

      Participants are put into 2 groups by chance. One group of participants gets BI 764198
      capsules and the other group gets placebo capsules. The placebo capsules look exactly like
      the BI 764198 capsules but do not contain any medicine. Participants take 1 capsule per day.

      Participants are in the study for about a month. At study end, doctors compare the 2 groups
      for the number of patients that are alive and do not need mechanical breathing support.
      During the study, the doctors collect information on any health problems of the participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 50 years

          -  SARS-CoV-2 infection positive confirmed by PCR or approved point-of-care test

          -  A score of 5 (hospitalised; oxygen by mask or nasal prongs) or 6 (hospitalised; oxygen
             by non-invasive ventilation or high flow), but not previously ≥7, on the WHO Clinical
             Progression Scale.

          -  Signed and dated written informed consent in accordance with ICH-GCP and local
             legislation prior to admission to the trial.

          -  Male or female patients. Women of childbearing potential (WOCBP) and men able to
             father a child must abstain from male female sex or must use highly effective methods
             of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per
             year when used consistently and correctly during hospitalisation for at least 7 days
             after last trial drug intake

        Exclusion Criteria:

          -  Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >5 × the upper limit
             of normal (ULN).

          -  Known active infection with HIV or hepatitis B or C.

          -  Pulmonary oedema/respiratory failure due to cardiogenic insult.

          -  Previous to hospitalisation, on long-term oxygen therapy.

          -  A confirmed baseline prolongation of QTc interval to greater than 450 ms in males or
             470 ms in females according to the Bazett formula, or any other relevant ECG finding
             at screening, or concomitant use of medication prolonging QT interval.

          -  Stage 4 severe chronic kidney disease or requiring dialysis (i.e., eGFR <30
             mL/min/1.73 m2).

        History of the following cardiac conditions:

          -  Myocardial infarction within 3 months prior to the first dose

          -  Unstable angina

          -  History of clinically significant long QT features on electrocardiogram (ECG) or
             history of familial long QT

               -  Anticipated transfer/discharge to another hospital or care facility other than
                  their place of residence

               -  Further exclusion criteria apply