Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003211-96 | EudraCT Number |
Not provided
Not provided
Not provided
Company decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 764198 treatment group | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 764198 | Drug | BI 764198 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Alive and Free of Mechanical Ventilation | Percentage of patients alive and free of mechanical ventilation at Day 29 is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128). | At Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Alive and Discharged Free of Oxygen Use | Percentage of patients alive and discharged free of oxygen use is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128). | At Day 29 |
| Percentage of Patients With Occurrence of Any Component of Composite: In-hospital Mortality or Intensive Care Unit (ICU) Admission or Mechanical Ventilation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868 | United States | ||
| Rapides Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37024277 | Derived | Ware LB, Soleymanlou N, McAuley DF, Estrada V, Diaz GA, Lacamera P, Kaste R, Choi W, Gupta A, Welte T. TRPC6 inhibitor (BI 764198) to reduce risk and severity of ARDS due to COVID-19: a phase II randomised controlled trial. Thorax. 2023 Aug;78(8):816-824. doi: 10.1136/thorax-2022-219668. Epub 2023 Apr 6. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
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.
This randomised, placebo-controlled, double-blind, proof-of-concept exploratory trial was to evaluate the efficacy and safety of BI 764198, an inhibitor of the transient receptor potential subtype C6 (TRPC6), compared to placebo in reducing risk or severity of acute respiratory distress syndrome (ARDS) in patients hospitalised for coronavirus disease appeared in 2019 (COVID-19).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BI 764198 Treatment Group | Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received BI 764198, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2021 | Feb 16, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo |
|
Percentage of patients with occurrence of any component of composite: In-hospital mortality or intensive care unit (ICU) admission or mechanical ventilation is presented. Efficacy endpoint meets when a patient has occurrence of any component of composite: In-hospital mortality or intensive care unit (ICU) admission or mechanical ventilation at Day 29. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128). |
| At Day 29 |
| Time to Clinical Improvement of at Least 2 Points (From Randomisation) on the World Health Organization Clinical Progression Scale, Discharge From the Hospital, or Considered Fit for Discharge | Meets when improvement of at least 2 points on World Health Organization (WHO) Clinical Progression Scale (CPS), discharge from hospital, fit for discharge (score 0, 1, 2, 3 on CPS), whichever comes first. WHO CPS: 0. Uninfected; no viral RNA detected; 1. Asymptomatic; viral RNA detected; 2. Symptomatic; independent; 3. Symptomatic; assistance needed; 4. Hospitalised; no oxygen therapy; 5. Hospitalised; oxygen by mask or nasal prongs; 6. Hospitalised; oxygen by non-invasive ventilation or high flow; 7. Intubation + mechanical ventilation, partial pressure of oxygen/fraction of inspired oxygen (pO2/FiO2) ≥150 or oxygen saturation/FiO2 (SpO2/FiO2) ≥200; 8. Mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors; 9. Mechanical ventilation pO2/FiO2 <150 + vasopressors, dialysis, extracorporeal membrane oxygenation (ECMO); 10. Death Only patients with event were analysed. One patient had no creatinine at baseline value, therefore excluded from statistical analysis (N=128). | Up to Day 29 |
| Number of Ventilator Free Days | Number of ventilator free days by Day 29 is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128). | Up to Day 29 |
| Percentage of Mortality at Day 15, 29, 60 and 90 | Percentage of mortality is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128). | At Day 15, 29, 60 and 90 |
| Alexandria |
| Louisiana |
| 71301 |
| United States |
| St. Elizabeth's Medical Center | Boston | Massachusetts | 02135 | United States |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| Mercy Health St. Vincent Medical Center | Toledo | Ohio | 43608 | United States |
| Providence Regional Medical Center | Everett | Washington | 98201 | United States |
| MultiCare Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| Hospital Luxemburgo | Belo Horizonte | 32380-490 | Brazil |
| IPECC - Instituto de Pesquisa Clínica de Campinas | Campinas | 13060-080 | Brazil |
| Hospital Ernesto Dornelles | Porto Alegre | 90160-092 | Brazil |
| Hospital Regional Hans Dieter Schmidt | Santa Catarina | 89227 | Brazil |
| Hospital de Base - Fac Med de Sao Jose do Rio Preto | São José do Rio Preto | 15090-000 | Brazil |
| Hospital Padre Alberto Hurtado | Santiago | 8880465 | Chile |
| Hospital Carlos Van Buren | Valparaíso | 2341131 | Chile |
| Hospital Cardiologica Aguascalientes | Aguascalientes | 20230 | Mexico |
| Hospital General de Culiacán "Dr. Bernardo J. Gastellum" | Culiacán | 80230 | Mexico |
| Hospital Universitario Dr Jose Eleuterio Gonzalez | Monterrey | 64460 | Mexico |
| Hospital Auxilio Mutuo | Hato Rey | 00919 | Puerto Rico |
| Hospital Municipal de San Juan | Rio Piedras | 00936 | Puerto Rico |
| Hospital A Coruña | A Coruña | 15006 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Son Espases | Palma de Mallorca | 07120 | Spain |
Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received Placebo, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): FAS included all patients (pts) in randomized set (RS) who received at least 1 dose of trial drug, comprised 129 pts (85.4%). Of all pts randomised, number (%) of pts not treated was similar in BI 764198 (2/67 pts [3.0%]) and placebo group (2/66 pts [3.0%]). The 4 pts excluded from FAS discontinued trial before receiving treatment for following reasons: pt's withdrawal (n=2), meeting an exclusion criterion (n=1), and clinical worsening (n=1).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BI 764198 Treatment Group | Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received BI 764198, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days. |
| BG001 | Placebo | Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received Placebo, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Alive and Free of Mechanical Ventilation | Percentage of patients alive and free of mechanical ventilation at Day 29 is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128). | Full Analysis Set (FAS): FAS included all patients (pts) in randomized set (RS) who received at least 1 dose of trial drug, comprised 129 pts (85.4%). Of all pts randomised, number (%) of pts not treated was similar in BI 764198 (2/67 pts [3.0%]) and placebo group (2/66 pts [3.0%]). The 4 pts excluded from FAS discontinued trial before receiving treatment for following reasons: pt's withdrawal (n=2), meeting an exclusion criterion (n=1), and clinical worsening (n=1). | Posted | Number | Percentage of patients | At Day 29 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Alive and Discharged Free of Oxygen Use | Percentage of patients alive and discharged free of oxygen use is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128). | Full Analysis Set (FAS): FAS included all patients (pts) in randomized set (RS) who received at least 1 dose of trial drug, comprised 129 pts (85.4%). Of all pts randomised, number (%) of pts not treated was similar in BI 764198 (2/67 pts [3.0%]) and placebo group (2/66 pts [3.0%]). The 4 pts excluded from FAS discontinued trial before receiving treatment for following reasons: pt's withdrawal (n=2), meeting an exclusion criterion (n=1), and clinical worsening (n=1). | Posted | Number | Percentage of patients | At Day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Occurrence of Any Component of Composite: In-hospital Mortality or Intensive Care Unit (ICU) Admission or Mechanical Ventilation | Percentage of patients with occurrence of any component of composite: In-hospital mortality or intensive care unit (ICU) admission or mechanical ventilation is presented. Efficacy endpoint meets when a patient has occurrence of any component of composite: In-hospital mortality or intensive care unit (ICU) admission or mechanical ventilation at Day 29. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128). | Full Analysis Set (FAS): FAS included all patients (pts) in randomized set (RS) who received at least 1 dose of trial drug, comprised 129 pts (85.4%). Of all pts randomised, number (%) of pts not treated was similar in BI 764198 (2/67 pts [3.0%]) and placebo group (2/66 pts [3.0%]). The 4 pts excluded from FAS discontinued trial before receiving treatment for following reasons: pt's withdrawal (n=2), meeting an exclusion criterion (n=1), and clinical worsening (n=1). | Posted | Number | Percentage of patients | At Day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Clinical Improvement of at Least 2 Points (From Randomisation) on the World Health Organization Clinical Progression Scale, Discharge From the Hospital, or Considered Fit for Discharge | Meets when improvement of at least 2 points on World Health Organization (WHO) Clinical Progression Scale (CPS), discharge from hospital, fit for discharge (score 0, 1, 2, 3 on CPS), whichever comes first. WHO CPS: 0. Uninfected; no viral RNA detected; 1. Asymptomatic; viral RNA detected; 2. Symptomatic; independent; 3. Symptomatic; assistance needed; 4. Hospitalised; no oxygen therapy; 5. Hospitalised; oxygen by mask or nasal prongs; 6. Hospitalised; oxygen by non-invasive ventilation or high flow; 7. Intubation + mechanical ventilation, partial pressure of oxygen/fraction of inspired oxygen (pO2/FiO2) ≥150 or oxygen saturation/FiO2 (SpO2/FiO2) ≥200; 8. Mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors; 9. Mechanical ventilation pO2/FiO2 <150 + vasopressors, dialysis, extracorporeal membrane oxygenation (ECMO); 10. Death Only patients with event were analysed. One patient had no creatinine at baseline value, therefore excluded from statistical analysis (N=128). | Full Analysis Set (FAS): FAS included all patients (pts) in randomized set (RS) who received at least 1 dose of trial drug, comprised 129 pts (85.4%). Of all pts randomised, number (%) of pts not treated was similar in BI 764198 (2/67 pts [3.0%]) and placebo group (2/66 pts [3.0%]). The 4 pts excluded from FAS discontinued trial before receiving treatment for following reasons: pt's withdrawal (n=2), meeting an exclusion criterion (n=1), and clinical worsening (n=1). | Posted | Median | Inter-Quartile Range | Days | Up to Day 29 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Ventilator Free Days | Number of ventilator free days by Day 29 is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128). | Full Analysis Set (FAS): FAS included all patients (pts) in randomized set (RS) who received at least 1 dose of trial drug, comprised 129 pts. Only pts with non-missing results were included. Of all pts randomised, number of pts not treated was similar in BI 764198 (2/67 pts) and placebo group (2/66 pts). The 4 pts excluded from FAS discontinued trial before receiving treatment for following reasons: pt's withdrawal (n=2), meeting an exclusion criterion (n=1), and clinical worsening (n=1). | Posted | Mean | Standard Deviation | Days | Up to Day 29 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Mortality at Day 15, 29, 60 and 90 | Percentage of mortality is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128). | Full Analysis Set (FAS): FAS included all patients (pts) in randomized set (RS) who received at least 1 dose of trial drug, comprised 129 pts (85.4%). Of all pts randomised, number (%) of pts not treated was similar in BI 764198 (2/67 pts [3.0%]) and placebo group (2/66 pts [3.0%]). The 4 pts excluded from FAS discontinued trial before receiving treatment for following reasons: pt's withdrawal (n=2), meeting an exclusion criterion (n=1), and clinical worsening (n=1). | Posted | Number | Percentage of patients | At Day 15, 29, 60 and 90 |
|
From first administration of the study drug to end of study, 90 days in total.
Full Analysis Set (FAS): FAS included all patients (pts) in randomized set (RS) who received at least 1 dose of trial drug, comprised 129 pts (85.4%). Of all pts randomised, number (%) of pts not treated was similar in BI 764198 (2/67 pts [3.0%]) and placebo group (2/66 pts [3.0%]). The 4 pts excluded from FAS discontinued trial before receiving treatment for following reasons: pt's withdrawal (n=2), meeting an exclusion criterion (n=1), and clinical worsening (n=1).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BI 764198 Treatment Group | Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received BI 764198, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days. | 11 | 65 | 19 | 65 | 10 | 65 |
| EG001 | Placebo | Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received Placebo, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days. | 5 | 64 | 17 | 64 | 12 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diastolic dysfunction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Right ventricular dilatation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Right ventricular dysfunction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Citrobacter infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Distributive shock | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
This trial was terminated early following the recommendation of a Data Monitoring Committee.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 8, 2021 | Mar 11, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received Placebo, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days.
|
|
|
Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received BI 764198, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days. |
| OG001 | Placebo | Subjects who were hospitalised for infection with SARS-CoV-2, the virus that causes COVID-19 received Placebo, oral or, only if needed, per nasogastric intubation once per day starting on Day 1, with a treatment duration of up to 28 days. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|