ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19

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