COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04604184

Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

2020-10-27

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

- 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

2

Boehringer Ingelheim

50

100

Brazil;Chile;Mexico;Puerto Rico;Spain;United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

133

Percentage of Patients Alive and Free of Mechanical Ventilation

None

Phase 2

[{"arm_notes": "", "treatment_id": 202, "treatment_name": "Bi 764198", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]