COVID-19
Conditions
Brief summary
This study is open to adults with mild to moderate symptoms of COVID-19 (coronavirus disease). The purpose of this study is to find out whether a medicine called BI 767551 helps people with COVID-19. BI 767551 is an antibody against the coronavirus. The study has 2 parts. Part 1 wants to find out the best dose of BI 767551 given as infusion into a vein. It also tests how BI 767551 is taken up by the body when taken via an inhaler. Participants are put into 4 groups by chance. Participants get BI 767551 or placebo once. * 1 group gets a high dose of BI 767551 as an infusion into a vein * 1 group gets a low dose of BI 767551 as an infusion into a vein * 1 group gets BI 767551 via an inhaler * 1 group gets placebo both as an infusion into a vein and via an inhaler The placebo infusion and inhaler look like the BI 767551 infusion and inhaler but do not contain any medicine. Doctors check how BI 767551 reduces the amount of coronavirus. Once the best dose of BI 767551 is found, part 2 of the study tests BI 767551 in a larger group of people. Also, in part 2, the participants get BI 767551 or placebo as an infusion into a vein once. In this part, doctors will check how many people need to be treated in a hospital or die. The results will be compared between the groups. For each part, participants are in the study for about 13 weeks. During this time, they visit the study site about 8 times and get about 3 remote visits. The doctors also regularly check participants' health and take note of any unwanted effects of BI 767551.
Interventions
BI 767551 intravenous
DRUGBI 767551 inhaled
BI 767551 inhaled
Placebo intravenous
DRUGPlacebo inhaled
Placebo inhaled
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This trial consists of two phases: Exploratory Phase II: Randomised, double-blind, placebo controlled, doubledummy,Phase II, parallel group design comparing different doses and modes of administration of BI 767551 to placebo. Confirmatory Phase III: Randomised, double-blind, placebo-controlled, parallel group, Phase III comparing BI 767551 to placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase II: Time-weighted Change From Baseline in Viral Shedding Over 8 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) | Up to 8 days | Time-weighted change from baseline in viral shedding over 8 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR), defined as a absolute change from baseline in log10 viral load, is reported. |
| Phase II: Time-weighted Change From Baseline in Viral Shedding Over 29 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) | Up to 29 days | Time-weighted change from baseline in viral shedding over 29 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR), defined as a absolute change from baseline in log10 viral load, is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | At Day 4, Day 8, Day 15, Day 22, and Day 29 | Number of participants with loss of detection of Severe acute respiratory syndrome coronavirus 2 ribonucleic acid (SARS-CoV-2 RNA) by site collected NP swab at Day 4, 8, 15, 22 and 29 is report. The Yes = loss of detection of SARS-CoV-2 RNA; No = SARS-CoV-2 RNA detected; Missing = not evaluable. |
Countries
Spain, United States
Participant flow
Recruitment details
This study was planned to evaluate the concept of pharmacological activity of BI 767551 in non-hospitalised patients with mild to moderate COVID-19 symptoms. The study was terminated early. 5 patients total participated in phase II and phase III was not conducted.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Intravenous (i.v.) + Placebo Inhaled Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) 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. | 2 |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) 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. | 1 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Not treated | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Total |
|---|---|---|---|
| Age, Continuous | 35.5 Years STANDARD_DEVIATION 10.6 | 37.0 Years | 36.0 Years STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Log-transformed Nasopharyngeal (NP) swab viral load at baseline | 5.24 log10 copies / milliliter STANDARD_DEVIATION 2.09 | 7.32 log10 copies / milliliter | 5.93 log10 copies / milliliter STANDARD_DEVIATION 1.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 2 / 2 | 1 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Phase II: Time-weighted Change From Baseline in Viral Shedding Over 29 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)
Time-weighted change from baseline in viral shedding over 29 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR), defined as a absolute change from baseline in log10 viral load, is reported.
Time frame: Up to 29 days
Population: Modified Intention-To-Treat set (mITT): This subject set includes all randomised subjects that received any amount of study drug and who have at least a measurable baseline value (above Lower limit of quantification (LLOQ)) and a second measurement in the first week (up to 7 days after drug intake) of SARS-CoV-2 RNA by site collected nasopharyngeal (NP) swab.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Time-weighted Change From Baseline in Viral Shedding Over 29 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) | -2.09 log10 copies / milliliter | Standard Deviation 1.6 |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Time-weighted Change From Baseline in Viral Shedding Over 29 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) | -4.18 log10 copies / milliliter | — |
Primary
Phase II: Time-weighted Change From Baseline in Viral Shedding Over 8 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)
Time-weighted change from baseline in viral shedding over 8 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR), defined as a absolute change from baseline in log10 viral load, is reported.
Time frame: Up to 8 days
Population: Modified Intention-To-Treat set (mITT): This subject set includes all randomised subjects that received any amount of study drug and who have at least a measurable baseline value (above Lower limit of quantification (LLOQ)) and a second measurement in the first week (up to 7 days after drug intake) of SARS-CoV-2 RNA by site collected nasopharyngeal (NP) swab.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Time-weighted Change From Baseline in Viral Shedding Over 8 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) | 0.15 log10 copies / milliliter | Standard Deviation 1.25 |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Time-weighted Change From Baseline in Viral Shedding Over 8 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR) | -2.84 log10 copies / milliliter | — |
Secondary
Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29
Number of participants with loss of detection of Severe acute respiratory syndrome coronavirus 2 ribonucleic acid (SARS-CoV-2 RNA) by site collected NP swab at Day 4, 8, 15, 22 and 29 is report. The Yes = loss of detection of SARS-CoV-2 RNA; No = SARS-CoV-2 RNA detected; Missing = not evaluable.
Time frame: At Day 4, Day 8, Day 15, Day 22, and Day 29
Population: Treated set (TS): This subject set includes all subjects who received any amount of study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 15 | No | 1 Participants |
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 4 | No | 2 Participants |
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 4 | Missing | 0 Participants |
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 29 | Yes | 0 Participants |
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 22 | No | 0 Participants |
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 8 | No | 2 Participants |
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 29 | No | 0 Participants |
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 8 | Missing | 0 Participants |
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 8 | Yes | 0 Participants |
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 15 | Yes | 1 Participants |
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 29 | Missing | 2 Participants |
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 15 | Missing | 0 Participants |
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 22 | Missing | 1 Participants |
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 22 | Yes | 1 Participants |
| Placebo Intravenous (i.v.) + Placebo Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 4 | Yes | 0 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 22 | Yes | 0 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 15 | Yes | 1 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 22 | No | 0 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 22 | Missing | 1 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 29 | Yes | 0 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 29 | No | 0 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 29 | Missing | 1 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 4 | Yes | 0 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 4 | Missing | 0 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 8 | Yes | 0 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 8 | No | 1 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 8 | Missing | 0 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 15 | No | 0 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 15 | Missing | 0 Participants |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29 | Day 4 | No | 1 Participants |