A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19
COVID-19
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion criteria phase II and III:
- ≥ 18 years old, males and females
- Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Documentation of laboratory-confirmed Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (nasopharyngeal (NP) or nasal swab or saliva) collected no more than 72 hours prior to start of treatment
- Patients experienced mild to moderate Coronavirus Disease 2019 (COVID-19)-related symptoms or measured fever for no more than 5 days prior to start of treatment where symptoms are defined by fever, feeling feverish, fatigue, cough, shortness of breath at rest or during activity, sore throat, body pain or muscle pain/ aches, chills, headache, nasal obstruction or congestion, loss of smell or taste, nausea, diarrhea, vomiting, or dysgeusia
- One or more of the following signs/symptoms present on day of start of treatment: fever, feeling feverish, fatigue, cough, shortness of breath at rest or during activity, sore throat, body pain or muscle pain/ aches, chills, headache, nasal obstruction or congestion, loss of smell or taste, nausea, diarrhea, vomiting, or dysgeusia
- Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to 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
Exclusion criteria phase II and III:
- Body weight of less than 40 kg
Severe or critical COVID-19 including at least one of
- Oxygen saturation (SpO2) ≤ 93 % on room air or on their usual level of oxygen supplementation in case of chronic oxygen use
- Ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) < 300 (in case arterial blood sample was taken)
- History of hospitalization for COVID-19
- Current or imminent need for hospitalization or immediate medical attention in the clinical opinion of the site investigator. Does not include patients hospitalized for isolation only
- Receipt of intravenous immunoglobulin within 12 weeks prior to Visit 2
- Receipt of COVID-19 convalescent plasma treatment at any time prior to Visit 2
- Receipt of any SARS-CoV-2 monoclonal antibody treatment at any time prior to Visit 2
- Receipt of SARS-CoV-2 vaccine at any time prior to Visit 2
- Receipt of an investigational product for COVID-19 within 5 half-lives prior to Visit 2
- Receipt of systemic steroids (e.g. prednisone, dexamethasone) within 4 weeks prior to Visit 2 unless used for chronic condition Further exclusion criteria apply.
Exclusion criterion phase III only:
- Previous enrolment in this trial. Patients participating in Phase II are not eligible for Phase III. Re-screening is allowed once, for repeat of Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR) or antigen SARS-CoV-2 test, if required. The test method used for initial screening (RT-qPCR or antigen) should be used for re-screening.
Sites / Locations
- Ocean Blue Medical Research Center, Inc.
- Pharmatex Research
- Advanced Surgeons and Physicians Network
- Crossroads Clinical Research
- Hospital Universitario Infanta Leonor
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Phase II, Arm 1: Placebo intravenous (i.v.) + placebo inhaled
Phase II, Arm 2: BI 767551 10 milligrams (mg)/kilogram (kg) intravenous (i.v.) + placebo inhaled
Phase II, Arm 3: BI 767551 40 mg/kg intravenous (i.v.) + placebo inhaled
Phase II, Arm 4: Placebo intravenous (i.v.) + BI 767551 250 mg inhaled
Phase III, Arm 1: BI 767551 (medium or high dose infusion) or low dose inhalation
Phase III, Arm 2: Placebo
Single dose of sterile normal saline (NaCl 0.9%) used as placebo for intravenous (i.v.) was administered as intravenous infusion over a period of 60 minutes plus a single inhaled of solvent for dilution of BI 767551 used as placebo for inhalation administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.
Single dose of sterile normal saline (NaCl 0.9%) used as placebo for intravenous (i.v.) was administered as intravenous infusion over a period of 60 minutes plus a single inhaled of 250 milligrams (mg) of BI 767551 administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.