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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04604184
Recruitment Status : Terminated (Company decision)
First Posted : October 27, 2020
Results First Posted : April 11, 2022
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition COVID-19
Interventions Drug: BI 764198
Drug: Placebo
Enrollment 133
Recruitment Details 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).
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.
Arm/Group Title BI 764198 Treatment Group Placebo
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 67 66
Treated 65 64
Completed 47 47
Not Completed 20 19
Reason Not Completed
Adverse Event             5             5
Death             2             1
Withdrawal by Subject             1             3
Not treated             2             2
Due to sponsor decision             9             7
Physician Decision             0             1
Transfer to healthcare             1             0
Arm/Group Title BI 764198 Treatment Group Placebo Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 65 64 129
Hide Baseline Analysis Population Description
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).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 64 participants 129 participants
63.8  (8.3) 63.6  (7.9) 63.7  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 64 participants 129 participants
Female
24
  36.9%
25
  39.1%
49
  38.0%
Male
41
  63.1%
39
  60.9%
80
  62.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 64 participants 129 participants
Hispanic or Latino
39
  60.0%
35
  54.7%
74
  57.4%
Not Hispanic or Latino
26
  40.0%
29
  45.3%
55
  42.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 64 participants 129 participants
American Indian or Alaska Native
5
   7.7%
7
  10.9%
12
   9.3%
Asian
0
   0.0%
3
   4.7%
3
   2.3%
Native Hawaiian or Other Pacific Islander
2
   3.1%
0
   0.0%
2
   1.6%
Black or African American
3
   4.6%
3
   4.7%
6
   4.7%
White
53
  81.5%
47
  73.4%
100
  77.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   3.1%
4
   6.3%
6
   4.7%
1.Primary Outcome
Title Percentage of Patients Alive and Free of Mechanical Ventilation
Hide Description

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).
Time Frame At Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title BI 764198 Treatment Group Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 65 64
Measure Type: Number
Unit of Measure: Percentage of patients
83.1 87.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 764198 Treatment Group, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3232
Comments [Not Specified]
Method Regression, Logistic
Comments includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -5.39
Confidence Interval (2-Sided) 95%
-16.08 to 5.30
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Patients Alive and Discharged Free of Oxygen Use
Hide Description 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).
Time Frame At Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title BI 764198 Treatment Group Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 65 64
Measure Type: Number
Unit of Measure: Percentage of patients
75.4 82.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 764198 Treatment Group, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1274
Comments [Not Specified]
Method Regression, Logistic
Comments includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -9.86
Confidence Interval (2-Sided) 95%
-22.54 to 2.82
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Patients With Occurrence of Any Component of Composite: In-hospital Mortality or Intensive Care Unit (ICU) Admission or Mechanical Ventilation
Hide Description

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).
Time Frame At Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title BI 764198 Treatment Group Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 65 64
Measure Type: Number
Unit of Measure: Percentage of patients
26.2 23.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 764198 Treatment Group, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6828
Comments [Not Specified]
Method Regression, Logistic
Comments includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 2.66
Confidence Interval (2-Sided) 95%
-10.11 to 15.43
Estimation Comments [Not Specified]
4.Secondary Outcome
Title 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
Hide Description

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).
Time Frame Up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title BI 764198 Treatment Group Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 65 64
Median (Inter-Quartile Range)
Unit of Measure: Days
9
(6 to 24)
7
(5 to 10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 764198 Treatment Group, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0445
Comments [Not Specified]
Method Regression, Cox
Comments Covariates are treatment, age, severity grade and creatinine at baseline and duration of symptoms before hospitalization
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.46 to 0.99
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Ventilator Free Days
Hide Description 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).
Time Frame Up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title BI 764198 Treatment Group Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 65 64
Mean (Standard Deviation)
Unit of Measure: Days
24.12  (8.81) 25.08  (7.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 764198 Treatment Group, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5526
Comments [Not Specified]
Method ANCOVA
Comments Fixed effects of treatment, age, severity grade and creatinine at baseline and duration of symptoms before hospitalisation as covariates
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.80
Confidence Interval (2-Sided) 95%
-3.47 to 1.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.35
Estimation Comments Difference = covariate adjusted BI 764198 - covariate adjusted Placebo
6.Secondary Outcome
Title Percentage of Mortality at Day 15, 29, 60 and 90
Hide Description Percentage of mortality is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).
Time Frame At Day 15, 29, 60 and 90
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title BI 764198 Treatment Group Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 65 64
Measure Type: Number
Unit of Measure: Percentage of patients
Day 15 6.2 1.6
Day 29 12.3 7.8
Day 60 15.4 7.8
Day 90 16.9 7.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 764198 Treatment Group, Placebo
Comments Day 15
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0995
Comments [Not Specified]
Method Regression, Logistic
Comments Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 5.32
Confidence Interval (2-Sided) 95%
-1.01 to 11.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BI 764198 Treatment Group, Placebo
Comments Day 29
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1992
Comments [Not Specified]
Method Regression, Logistic
Comments Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 6.06
Confidence Interval (2-Sided) 95%
-3.19 to 15.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BI 764198 Treatment Group, Placebo
Comments Day 60
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0709
Comments [Not Specified]
Method Regression, Logistic
Comments Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 8.93
Confidence Interval (2-Sided) 95%
-0.76 to 18.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BI 764198 Treatment Group, Placebo
Comments Day 90
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0412
Comments [Not Specified]
Method Regression, Logistic
Comments Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.35
Confidence Interval (2-Sided) 95%
0.41 to 20.28
Estimation Comments [Not Specified]
Time Frame From first administration of the study drug to end of study, 90 days in total.
Adverse Event Reporting Description 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).
 
Arm/Group Title BI 764198 Treatment Group Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
BI 764198 Treatment Group Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   11/65 (16.92%)   5/64 (7.81%) 
Hide Serious Adverse Events
BI 764198 Treatment Group Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   19/65 (29.23%)   17/64 (26.56%) 
Blood and lymphatic system disorders     
Anaemia † 1  1/65 (1.54%)  0/64 (0.00%) 
Cardiac disorders     
Cardiac failure congestive † 1  0/65 (0.00%)  2/64 (3.13%) 
Cardiac tamponade † 1  1/65 (1.54%)  0/64 (0.00%) 
Cardiac ventricular thrombosis † 1  0/65 (0.00%)  1/64 (1.56%) 
Cardiogenic shock † 1  1/65 (1.54%)  1/64 (1.56%) 
Diastolic dysfunction † 1  0/65 (0.00%)  1/64 (1.56%) 
Ventricular tachycardia † 1  0/65 (0.00%)  1/64 (1.56%) 
Acute myocardial infarction † 1  1/65 (1.54%)  0/64 (0.00%) 
Atrial fibrillation † 1  0/65 (0.00%)  1/64 (1.56%) 
Bradycardia † 1  0/65 (0.00%)  1/64 (1.56%) 
Right ventricular dilatation † 1  0/65 (0.00%)  1/64 (1.56%) 
Right ventricular dysfunction † 1  0/65 (0.00%)  1/64 (1.56%) 
Endocrine disorders     
Adrenal insufficiency † 1  0/65 (0.00%)  1/64 (1.56%) 
Gastrointestinal disorders     
Diarrhoea † 1  1/65 (1.54%)  0/64 (0.00%) 
General disorders     
Death † 1  1/65 (1.54%)  0/64 (0.00%) 
Multiple organ dysfunction syndrome † 1  1/65 (1.54%)  0/64 (0.00%) 
Hepatobiliary disorders     
Hepatitis toxic † 1  1/65 (1.54%)  0/64 (0.00%) 
Liver injury † 1  1/65 (1.54%)  0/64 (0.00%) 
Infections and infestations     
COVID-19 † 1  1/65 (1.54%)  2/64 (3.13%) 
COVID-19 pneumonia † 1  4/65 (6.15%)  2/64 (3.13%) 
Lower respiratory tract infection † 1  0/65 (0.00%)  1/64 (1.56%) 
Septic shock † 1  2/65 (3.08%)  3/64 (4.69%) 
Aspergillus infection † 1  1/65 (1.54%)  0/64 (0.00%) 
Citrobacter infection † 1  1/65 (1.54%)  0/64 (0.00%) 
Lower respiratory tract infection bacterial † 1  1/65 (1.54%)  0/64 (0.00%) 
Pneumonia † 1  2/65 (3.08%)  0/64 (0.00%) 
Sepsis † 1  1/65 (1.54%)  1/64 (1.56%) 
Investigations     
Electrocardiogram QT prolonged † 1  0/65 (0.00%)  1/64 (1.56%) 
Metabolism and nutrition disorders     
Hyperkalaemia † 1  0/65 (0.00%)  1/64 (1.56%) 
Nervous system disorders     
Encephalopathy † 1  0/65 (0.00%)  1/64 (1.56%) 
Ischaemic stroke † 1  1/65 (1.54%)  0/64 (0.00%) 
Toxic encephalopathy † 1  2/65 (3.08%)  0/64 (0.00%) 
Psychiatric disorders     
Delirium † 1  1/65 (1.54%)  1/64 (1.56%) 
Renal and urinary disorders     
Acute kidney injury † 1  4/65 (6.15%)  5/64 (7.81%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome † 1  2/65 (3.08%)  3/64 (4.69%) 
Acute respiratory failure † 1  3/65 (4.62%)  2/64 (3.13%) 
Dyspnoea † 1  1/65 (1.54%)  0/64 (0.00%) 
Haemothorax † 1  1/65 (1.54%)  0/64 (0.00%) 
Hypoxia † 1  2/65 (3.08%)  0/64 (0.00%) 
Pneumomediastinum † 1  2/65 (3.08%)  1/64 (1.56%) 
Pneumothorax † 1  1/65 (1.54%)  2/64 (3.13%) 
Pulmonary embolism † 1  0/65 (0.00%)  1/64 (1.56%) 
Respiratory distress † 1  0/65 (0.00%)  1/64 (1.56%) 
Respiratory failure † 1  4/65 (6.15%)  5/64 (7.81%) 
Pulmonary hypertension † 1  1/65 (1.54%)  1/64 (1.56%) 
Vascular disorders     
Deep vein thrombosis † 1  1/65 (1.54%)  1/64 (1.56%) 
Distributive shock † 1  1/65 (1.54%)  0/64 (0.00%) 
Hypotension † 1  0/65 (0.00%)  1/64 (1.56%) 
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BI 764198 Treatment Group Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   10/65 (15.38%)   12/64 (18.75%) 
Cardiac disorders     
Tachycardia † 1  0/65 (0.00%)  4/64 (6.25%) 
Gastrointestinal disorders     
Constipation † 1  4/65 (6.15%)  6/64 (9.38%) 
Investigations     
Electrocardiogram QT prolonged † 1  3/65 (4.62%)  4/64 (6.25%) 
Metabolism and nutrition disorders     
Hyperkalaemia † 1  2/65 (3.08%)  6/64 (9.38%) 
Vascular disorders     
Hypotension † 1  4/65 (6.15%)  5/64 (7.81%) 
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
This trial was terminated early following the recommendation of a Data Monitoring Committee.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04604184    
Other Study ID Numbers: 1434-0009
2020-003211-96 ( EudraCT Number )
First Submitted: October 26, 2020
First Posted: October 27, 2020
Results First Submitted: March 22, 2022
Results First Posted: April 11, 2022
Last Update Posted: April 11, 2022