Trial Outcomes & Findings for Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia (NCT NCT04382053)
NCT ID: NCT04382053
Last Updated: 2022-07-26
Results Overview
The APACHE II ("Acute Physiology And Chronic Health Evaluation II") is a severity-of-disease classification system. An integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death. In practice, it is rare for any participant to accumulate more than 55 points. APACHE II score was measured on Day 15 or on the day of discharge (whichever was earlier). Participants who died on Day 15 or earlier were assigned the highest observed APACHE II score of any of the participants at any time during the trial (worst case imputation for deaths). Missing data values of the parameters required for the derivation of the APACHE II score were replaced by the last available assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
up to Day 15
Results posted on
2022-07-26
Participant Flow
Participants were recruited from 30 sites in 12 countries.
Participants underwent a Screening period of up to 24 hours which included screening and baseline assessments.
Participant milestones
| Measure |
DFV890 + SoC
DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC.
|
Standard of Care (SoC)
SoC was used as an active comparator arm.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
72
|
|
Overall Study
Safety Analysis Set
|
70
|
72
|
|
Overall Study
PD Analysis Set
|
62
|
68
|
|
Overall Study
COMPLETED
|
62
|
59
|
|
Overall Study
NOT COMPLETED
|
9
|
13
|
Reasons for withdrawal
| Measure |
DFV890 + SoC
DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC.
|
Standard of Care (SoC)
SoC was used as an active comparator arm.
|
|---|---|---|
|
Overall Study
Death
|
6
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Protocol Deviation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia
Baseline characteristics by cohort
| Measure |
DFV890 + SoC
n=71 Participants
DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC.
|
Standard of Care (SoC)
n=72 Participants
SoC was used as an active comparator arm.
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 Years
STANDARD_DEVIATION 13.31 • n=5 Participants
|
61.5 Years
STANDARD_DEVIATION 10.38 • n=7 Participants
|
60.8 Years
STANDARD_DEVIATION 11.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to Day 15Population: Safety analysis set: All randomized participants, who attended at least one post-baseline visit.
The APACHE II ("Acute Physiology And Chronic Health Evaluation II") is a severity-of-disease classification system. An integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death. In practice, it is rare for any participant to accumulate more than 55 points. APACHE II score was measured on Day 15 or on the day of discharge (whichever was earlier). Participants who died on Day 15 or earlier were assigned the highest observed APACHE II score of any of the participants at any time during the trial (worst case imputation for deaths). Missing data values of the parameters required for the derivation of the APACHE II score were replaced by the last available assessment.
Outcome measures
| Measure |
DFV890 + SoC
n=70 Participants
DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC.
|
Standard of Care (SoC)
n=72 Participants
SoC was used as an active comparator arm.
|
|---|---|---|
|
APACHE II Severity of Disease Score on Day 15 or on the Day of Discharge (Whichever is Earlier)
|
8.7 Score on a scale
Standard Error 1.06
|
8.6 Score on a scale
Standard Error 1.05
|
SECONDARY outcome
Timeframe: Days 2, 4, 6, 8, 10, 12, 14 and 15Population: PD analysis set: All randomized participants with no protocol deviations with relevant impact on PD data.
C-reactive protein (CRP) is a blood test marker for inflammation in the body. It was analyzed on a log-scale fitting a repeated measures mixed model including treatment group, study day, the three stratification factors and log transformed baseline CRP as a covariate. Values reported were back-transformed to original scale.
Outcome measures
| Measure |
DFV890 + SoC
n=62 Participants
DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC.
|
Standard of Care (SoC)
n=68 Participants
SoC was used as an active comparator arm.
|
|---|---|---|
|
Serum C-reactive Protein (CRP) Levels
Day 2
|
31.4 Milligram / Liter
Standard Error 1.14
|
46.6 Milligram / Liter
Standard Error 1.13
|
|
Serum C-reactive Protein (CRP) Levels
Day 4
|
22.2 Milligram / Liter
Standard Error 1.19
|
26.5 Milligram / Liter
Standard Error 1.18
|
|
Serum C-reactive Protein (CRP) Levels
Day 6
|
11.5 Milligram / Liter
Standard Error 1.2
|
15.1 Milligram / Liter
Standard Error 1.19
|
|
Serum C-reactive Protein (CRP) Levels
Day 8
|
7.7 Milligram / Liter
Standard Error 1.25
|
10.9 Milligram / Liter
Standard Error 1.24
|
|
Serum C-reactive Protein (CRP) Levels
Day 10
|
7.0 Milligram / Liter
Standard Error 1.27
|
8.0 Milligram / Liter
Standard Error 1.27
|
|
Serum C-reactive Protein (CRP) Levels
Day 12
|
7.5 Milligram / Liter
Standard Error 1.30
|
7.1 Milligram / Liter
Standard Error 1.31
|
|
Serum C-reactive Protein (CRP) Levels
Day 14
|
8.1 Milligram / Liter
Standard Error 1.31
|
6.3 Milligram / Liter
Standard Error 1.31
|
|
Serum C-reactive Protein (CRP) Levels
Day 15 / end of study
|
6.9 Milligram / Liter
Standard Error 1.27
|
8.2 Milligram / Liter
Standard Error 1.26
|
SECONDARY outcome
Timeframe: Baseline, days 2, 4, 6, 8, 10, 12, 14, 15, 17, 19, 21, 23, 25, 27 and 29Population: Safety analysis set: All randomized participants, who attended at least one post-baseline visit.
Clinical status was measured with World Health Organization (WHO) 9-point ordinal scale. The scoring is - Uninfected patients have a score 0. - Ambulatory patients can have a score 1 (no limitation of activities) or 2 (limitation of activities). - Hospitalized patients with mild disease can have score 3 (no oxygen therapy) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation). - Patients who die have a score 8. Missing data values were handled as follows: For participants who died prior to Day 29, the score for death was imputed for all following visits up to and including day 29. For all the other participants, last observation carried forward was applied up to and including Day 29.
Outcome measures
| Measure |
DFV890 + SoC
n=70 Participants
DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC.
|
Standard of Care (SoC)
n=72 Participants
SoC was used as an active comparator arm.
|
|---|---|---|
|
Clinical Status Over Time
Day 17
|
2.7 Score on a scale
Standard Deviation 2.01
|
2.5 Score on a scale
Standard Deviation 2.22
|
|
Clinical Status Over Time
Baseline
|
4.3 Score on a scale
Standard Deviation 0.49
|
4.3 Score on a scale
Standard Deviation 0.44
|
|
Clinical Status Over Time
Day 2
|
4.3 Score on a scale
Standard Deviation 0.58
|
4.3 Score on a scale
Standard Deviation 0.80
|
|
Clinical Status Over Time
Day 4
|
4.3 Score on a scale
Standard Deviation 0.83
|
4.3 Score on a scale
Standard Deviation 0.95
|
|
Clinical Status Over Time
Day 6
|
3.9 Score on a scale
Standard Deviation 1.11
|
4.2 Score on a scale
Standard Deviation 1.13
|
|
Clinical Status Over Time
Day 8
|
3.8 Score on a scale
Standard Deviation 1.31
|
3.8 Score on a scale
Standard Deviation 1.50
|
|
Clinical Status Over Time
Day 10
|
3.6 Score on a scale
Standard Deviation 1.48
|
3.6 Score on a scale
Standard Deviation 1.88
|
|
Clinical Status Over Time
Day 12
|
3.4 Score on a scale
Standard Deviation 1.66
|
3.3 Score on a scale
Standard Deviation 1.98
|
|
Clinical Status Over Time
Day 14
|
3.3 Score on a scale
Standard Deviation 1.75
|
3.1 Score on a scale
Standard Deviation 2.03
|
|
Clinical Status Over Time
Day 15
|
2.8 Score on a scale
Standard Deviation 2.02
|
2.6 Score on a scale
Standard Deviation 2.24
|
|
Clinical Status Over Time
Day 21
|
2.6 Score on a scale
Standard Deviation 2.01
|
2.5 Score on a scale
Standard Deviation 2.33
|
|
Clinical Status Over Time
Day 23
|
2.6 Score on a scale
Standard Deviation 2.03
|
2.4 Score on a scale
Standard Deviation 2.31
|
|
Clinical Status Over Time
Day 25
|
2.6 Score on a scale
Standard Deviation 2.07
|
2.4 Score on a scale
Standard Deviation 2.31
|
|
Clinical Status Over Time
Dy 27
|
2.6 Score on a scale
Standard Deviation 2.10
|
2.4 Score on a scale
Standard Deviation 2.31
|
|
Clinical Status Over Time
Day 29
|
1.9 Score on a scale
Standard Deviation 2.34
|
1.9 Score on a scale
Standard Deviation 2.57
|
|
Clinical Status Over Time
Day 19
|
2.6 Score on a scale
Standard Deviation 2.01
|
2.5 Score on a scale
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: Until Day 15 (Assessments on Days 2, 4, 6, 8, 10, 12, 14 and 15) and until Day 29 (Assessments on Days 17, 19, 21, 23, 25, 27 and 29)Population: Safety analysis set: All randomized participants, who attended at least one post-baseline visit.
Number of participants not requiring mechanical ventilation for survival until Day 15 and Day 29: defined by WHO 9-point ordinal scale score of \< 6 points at all time points assessments. The scoring is - Uninfected patients have a score 0. - Ambulatory patients can have a score 1 (no limitation of activities) or 2 (limitation of activities). - Hospitalized patients with mild disease can have score 3 (no oxygen therapy) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support). - Patients who die have a score 8. Missing data values were handled as follows: For participants who died prior to Day 29, the score for death was imputed for all following visits up to and including day 29. For all the other participants, last observation carried forward was applied up to and including Day 29.
Outcome measures
| Measure |
DFV890 + SoC
n=70 Participants
DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC.
|
Standard of Care (SoC)
n=72 Participants
SoC was used as an active comparator arm.
|
|---|---|---|
|
Number of Participants Not Requiring Mechanical Ventilation for Survival
Until Day 15
|
60 Participants
|
59 Participants
|
|
Number of Participants Not Requiring Mechanical Ventilation for Survival
Until Day 29
|
60 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 15 and Day 29Population: Safety analysis set: All randomized participants, who attended at least one post-baseline visit.
Number of participants with at least one-point improvement from baseline in clinical status, which was measured with WHO 9-point ordinal scale. The scoring is - Uninfected patients have a score 0. - Ambulatory patients can have a score 1 (no limitation of activities) or 2 (limitation of activities). - Hospitalized patients with mild disease can have score 3 (no oxygen therapy) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support). - Patients who die have a score 8. Missing data values were handled as follows: For participants who died prior to Day 29, the score for death was imputed for all following visits up to and including day 29. For all the other participants, last observation carried forward was applied up to and including Day 29.
Outcome measures
| Measure |
DFV890 + SoC
n=70 Participants
DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC.
|
Standard of Care (SoC)
n=72 Participants
SoC was used as an active comparator arm.
|
|---|---|---|
|
Number of Participants With at Least One-point Improvement From Baseline in Clinical Status
Day 15
|
59 Participants
|
53 Participants
|
|
Number of Participants With at Least One-point Improvement From Baseline in Clinical Status
Day 29
|
61 Participants
|
60 Participants
|
Adverse Events
DFV890 + SoC
Serious events: 16 serious events
Other events: 12 other events
Deaths: 8 deaths
Standard of Care (SoC)
Serious events: 11 serious events
Other events: 6 other events
Deaths: 8 deaths
Total
Serious events: 27 serious events
Other events: 18 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
DFV890 + SoC
n=70 participants at risk
DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC.
|
Standard of Care (SoC)
n=72 participants at risk
SoC was used as an active comparator arm.
|
Total
n=142 participants at risk
Total
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Condition aggravated
|
1.4%
1/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.4%
1/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
COVID-19
|
0.00%
0/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
COVID-19 pneumonia
|
2.9%
2/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
2/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
4/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumonia
|
1.4%
1/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Sepsis
|
1.4%
1/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
2/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.1%
3/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Septic shock
|
1.4%
1/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
2/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Amylase increased
|
1.4%
1/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Polyneuropathy
|
1.4%
1/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
2/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
2/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
1/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
2/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
1/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.7%
4/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
4/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
8/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
1/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
2/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
2/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Peripheral artery thrombosis
|
1.4%
1/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Shock haemorrhagic
|
1.4%
1/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.70%
1/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Other adverse events
| Measure |
DFV890 + SoC
n=70 participants at risk
DFV890 50 mg was administered orally or nasogastrically twice per day (b.i.d) approximately 12 hours apart (morning and evening) for 14 days in addition to SoC.
|
Standard of Care (SoC)
n=72 participants at risk
SoC was used as an active comparator arm.
|
Total
n=142 participants at risk
Total
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
5/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
6.9%
5/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
7.0%
10/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.7%
4/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
4/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.7%
4/70 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
2/72 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
4.2%
6/142 • Adverse events were reported from the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 45 days.
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER