Trial Outcomes & Findings for INB03 for the Treatment of Pulmonary Complications From COVID-19 (NCT NCT04370236)
NCT ID: NCT04370236
Last Updated: 2026-05-19
Results Overview
Primary Endpoint: Cochran-Mantel-Haenszel Analysis of Proportion of Patients with Disease Progression (mITT Population)
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
79 participants
Primary outcome timeframe
28 days
Results posted on
2026-05-19
Participant Flow
There were 79 patients enrolled to either INB03 + SOC (n=40) or Placebo + SOC (n=39)
There were no stratification factors and each unblinded pharmacist was provided a randomization schedule unique to the specific site.
Participant milestones
| Measure |
INB03+SOC
This was the group of patients (n=40, 39 were dosed) that was randomized to and received at least one dose of INB03
|
Placebo+SOC
This was the group of patients (n=39, 38 were dosed) that was randomized and received at least one dose of placebo
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
39
|
|
Overall Study
mITT - Received at Least One Treatment (INB03 or Placebo)
|
39
|
38
|
|
Overall Study
Per-Protocol Population
|
35
|
38
|
|
Overall Study
Safety Population
|
39
|
38
|
|
Overall Study
COMPLETED
|
23
|
28
|
|
Overall Study
NOT COMPLETED
|
17
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
Baseline characteristics by cohort
| Measure |
INB03 + Standard of Care
n=39 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=38 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=50
|
12 Participants
n=30 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
16 Participants
n=30 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
28 Participants
n=60 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
|
Age, Customized
>50 to 65
|
14 Participants
n=30 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
16 Participants
n=30 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
30 Participants
n=60 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
|
Age, Customized
>65
|
13 Participants
n=30 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
6 Participants
n=30 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
19 Participants
n=60 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
|
Sex: Female, Male
Female
|
18 Participants
n=30 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
18 Participants
n=30 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
36 Participants
n=60 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
|
Sex: Female, Male
Male
|
21 Participants
n=30 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
20 Participants
n=30 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
41 Participants
n=60 Participants • Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized)
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
17 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=30 Participants
|
28 Participants
n=30 Participants
|
57 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: mITT population
Primary Endpoint: Cochran-Mantel-Haenszel Analysis of Proportion of Patients with Disease Progression (mITT Population)
Outcome measures
| Measure |
INB03 + Standard of Care
n=39 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=38 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
|---|---|---|
|
Cochran-Mantel-Haenszel Analysis of Proportion of Patients With Disease Progression
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Through study completion which could be up to Day 70Population: The mITT population was used for this analysis
Assessing the effect of INB03 on all-cause mortality in participants with pulmonary complications from COVID-19 infection (mITT Population)
Outcome measures
| Measure |
INB03 + Standard of Care
n=39 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=38 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
|---|---|---|
|
Proportion of Patients With All-cause Mortality
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Randomization to Day 28Proportion of participants who transferred to ICU level care by Day 28 (ICU level care is defined as a hospital setting where patient to nurse ratio is \< 4) - mITT population
Outcome measures
| Measure |
INB03 + Standard of Care
n=39 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=38 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
|---|---|---|
|
Proportion Transferred to ICU Level Care by Day 28
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Randomization to Day 28Proportion of participants with a new onset of neurologic disease (requiring medical intervention), including stroke by Day 28 (mITT population)
Outcome measures
| Measure |
INB03 + Standard of Care
n=39 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=38 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
|---|---|---|
|
Proportion With New Onset of Neurologic Disease by Day 28
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Randomization to Day 28Proportion of participants with evidence of new CHF or new MI requiring medical intervention by Day 28 - mITT population
Outcome measures
| Measure |
INB03 + Standard of Care
n=39 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=38 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
|---|---|---|
|
Proportion With Evidence of New CHF or New MI Requiring Medical Intervention by Day 28
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Randomization to Day 28Proportion of participants with a new onset embolus or thrombus by Day 28 - mITT population
Outcome measures
| Measure |
INB03 + Standard of Care
n=39 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=38 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
|---|---|---|
|
Proportion With New Onset Embolus or Thrombus by Day 28
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Randomization to Day 28Proportion of participants who develop a need for renal replacement therapy (defined as need for any type of dialysis including intermittent or continuous peritoneal or hemodialysis) by Day 28 - mITT population
Outcome measures
| Measure |
INB03 + Standard of Care
n=39 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=38 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
|---|---|---|
|
Proportion Developing a Need for Renal Replacement Therapy by Day 28
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study completion, which could be up to Day 70Proportion of participants with an increase in the WHO Ordinal Scale of Clinical Improvement score at any time during the study - mITT population
Outcome measures
| Measure |
INB03 + Standard of Care
n=39 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=38 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
|---|---|---|
|
Proportion With an Increase in the WHO Ordinal Scale of Clinical Improvement Score at Any Time During the Study
|
32 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Randomization to time of discharge or death, whichever occurs firtsPopulation: All of the 77 randomized participants in this study were hospitalized during this study.
Length of hospital stay defined as the number of days in hospital from time of randomization to time of discharge or death, whichever occurs first, mITT population
Outcome measures
| Measure |
INB03 + Standard of Care
n=39 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=38 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
|---|---|---|
|
Length of Hospital Stay
|
9.8 Day
Standard Deviation 10.17
|
7.1 Day
Standard Deviation 5.76
|
SECONDARY outcome
Timeframe: Baseline to Day 40Population: Not all patients on study reached Day 40. Not all subjects that did reach Day 40 had available samples for each inflammation marker.
Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - Troponin I
Outcome measures
| Measure |
INB03 + Standard of Care
n=9 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=8 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
|---|---|---|
|
Change From Baseline in Inflammation Markers Over Time - Troponin I
|
-0.01078 ng/ML
Standard Deviation 0.012853
|
-0.00650 ng/ML
Standard Deviation 0.007851
|
SECONDARY outcome
Timeframe: Baseline to Day 40Population: Not all patients on study reached Day 40. Not all subjects that did reach Day 40 had available samples for each inflammation marker.
Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - Glomerular Filtration Rate
Outcome measures
| Measure |
INB03 + Standard of Care
n=19 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=19 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
|---|---|---|
|
Change From Baseline in Inflammation Markers Over Time - Glomerular Filtration Rate
|
10.248 mL/min/1.73m2
Standard Deviation 22.9135
|
8.174 mL/min/1.73m2
Standard Deviation 28.1151
|
SECONDARY outcome
Timeframe: Baseline to Day 40Population: Not all patients on study reached Day 40. Not all subjects that did reach Day 40 had available samples for each inflammation marker.
Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - Ferritin
Outcome measures
| Measure |
INB03 + Standard of Care
n=19 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=19 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
|---|---|---|
|
Change From Baseline in Inflammation Markers Over Time - Ferritin
|
-137589.07 ug/L
Standard Deviation 288986.185
|
-209886.68 ug/L
Standard Deviation 424843.978
|
SECONDARY outcome
Timeframe: Baseline to Day 40Population: Not all patients on study reached Day 40. Not all subjects that did reach Day 40 had available samples for each inflammation marker.
Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - D-Dimer
Outcome measures
| Measure |
INB03 + Standard of Care
n=19 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=17 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
|---|---|---|
|
Change From Baseline in Inflammation Markers Over Time - D-Dimer
|
-0.896 mg/L FEU
Standard Deviation 2.8691
|
-0.342 mg/L FEU
Standard Deviation 0.5035
|
SECONDARY outcome
Timeframe: Baseline to Day 40Population: Not all patients on study reached Day 40. Not all subjects that did reach Day 40 had available samples for each inflammation marker.
Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - C-Reactive Protein
Outcome measures
| Measure |
INB03 + Standard of Care
n=19 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
Placebo + Standard of Care
n=19 Participants
Analyzed arms/groups were INB03+SOC and Placebo+SOC
|
|---|---|---|
|
Change From Baseline in Inflammation Markers Over Time - CRP
|
-1395.162 nmol/L
Standard Deviation 3636.4434
|
-1148.274 nmol/L
Standard Deviation 3821.7803
|
Adverse Events
INB03+SOC
Serious events: 8 serious events
Other events: 4 other events
Deaths: 4 deaths
Placebo+SOC
Serious events: 5 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
INB03+SOC
n=39 participants at risk
The clinical trial will have two treatment arms - INB03 + SOC or Placebo + SOC. All participants will receive a single dose of study drug by SC injection immediately upon randomization. Participants randomized to receive INB03 will receive INB03 1mg/kg (up to a maximum dose of 90mg) and participants randomized to Placebo will receive a SC injection of normal saline.
A second dose of INB03 1mg/kg or Placebo by SC injection will be administered on Study Day 8 to participants who remain in hospital.
|
Placebo+SOC
n=38 participants at risk
The clinical trial will have two treatment arms - INB03 + SOC or Placebo + SOC. All participants will receive a single dose of study drug by SC injection immediately upon randomization. Participants randomized to receive INB03 will receive INB03 1mg/kg (up to a maximum dose of 90mg) and participants randomized to Placebo will receive a SC injection of normal saline.
A second dose of INB03 1mg/kg or Placebo by SC injection will be administered on Study Day 8 to participants who remain in hospital.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
10.3%
4/39 • Number of events 4 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
5.3%
2/38 • Number of events 2 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Cardiac disorders
Cardiac Arrest
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
0.00%
0/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrom
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
0.00%
0/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
0.00%
0/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/39 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
2.6%
1/38 • Number of events 1 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
2.6%
1/38 • Number of events 1 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Vascular disorders
Hypotension
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
0.00%
0/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.1%
2/39 • Number of events 2 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
0.00%
0/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
0.00%
0/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
1/39 • Number of events 1 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
0.00%
0/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/39 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
2.6%
1/38 • Number of events 1 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/39 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
5.3%
2/38 • Number of events 2 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
Other adverse events
| Measure |
INB03+SOC
n=39 participants at risk
The clinical trial will have two treatment arms - INB03 + SOC or Placebo + SOC. All participants will receive a single dose of study drug by SC injection immediately upon randomization. Participants randomized to receive INB03 will receive INB03 1mg/kg (up to a maximum dose of 90mg) and participants randomized to Placebo will receive a SC injection of normal saline.
A second dose of INB03 1mg/kg or Placebo by SC injection will be administered on Study Day 8 to participants who remain in hospital.
|
Placebo+SOC
n=38 participants at risk
The clinical trial will have two treatment arms - INB03 + SOC or Placebo + SOC. All participants will receive a single dose of study drug by SC injection immediately upon randomization. Participants randomized to receive INB03 will receive INB03 1mg/kg (up to a maximum dose of 90mg) and participants randomized to Placebo will receive a SC injection of normal saline.
A second dose of INB03 1mg/kg or Placebo by SC injection will be administered on Study Day 8 to participants who remain in hospital.
|
|---|---|---|
|
Nervous system disorders
Headache
|
2.6%
1/39 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
10.5%
4/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Nervous system disorders
Dizziness
|
2.6%
1/39 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
5.3%
2/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
10.3%
4/39 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
5.3%
2/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
5.1%
2/39 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
0.00%
0/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.1%
2/39 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
0.00%
0/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Infections and infestations
Urinary tract infection
|
10.3%
4/39 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
0.00%
0/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia bacterial
|
2.6%
1/39 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
5.3%
2/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
3/39 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
2.6%
1/38 • Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place