Trial Outcomes & Findings for Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT) (NCT NCT04583592)
NCT ID: NCT04583592
Last Updated: 2022-01-18
Results Overview
Disease progression will be defined as the number of participants requiring hospitalization (including emergency room visit) or who die due to any cause within 28 days of randomization.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
295 participants
Primary outcome timeframe
28 days
Results posted on
2022-01-18
Participant Flow
The study was performed between November 09, 2020 to March, 30 2021. Subjects were recruited from \~25 sites across United States.
Participant milestones
| Measure |
Camostat Mesilate
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
194
|
101
|
|
Overall Study
COMPLETED
|
194
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)
Baseline characteristics by cohort
| Measure |
Camostat Mesilate
n=194 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=101 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 55 years
|
105 Participants
n=39 Participants
|
53 Participants
n=41 Participants
|
158 Participants
n=35 Participants
|
|
Age, Customized
> or = 55 years
|
89 Participants
n=39 Participants
|
48 Participants
n=41 Participants
|
137 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=39 Participants
|
61 Participants
n=41 Participants
|
169 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=39 Participants
|
40 Participants
n=41 Participants
|
126 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
115 Participants
n=39 Participants
|
62 Participants
n=41 Participants
|
177 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=39 Participants
|
39 Participants
n=41 Participants
|
117 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
153 Participants
n=39 Participants
|
80 Participants
n=41 Participants
|
233 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: The Intent-to-Treat population includes all subjects who were randomized
Disease progression will be defined as the number of participants requiring hospitalization (including emergency room visit) or who die due to any cause within 28 days of randomization.
Outcome measures
| Measure |
Camostat Mesilate
n=194 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=101 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Disease Progression at Day 28
|
10 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to Day 15 and Day 28The overall survival rate (the number of randomized participants who survive up to Day 15 and Day 28).
Outcome measures
| Measure |
Camostat Mesilate
n=194 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=101 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Survival Rate
Survival Status at Day 15
|
194 Participants
|
101 Participants
|
|
Survival Rate
Survival Status at Day 28
|
193 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysTime (in days) from initiation of study treatment until normalization of fever (≤ 37.2 °C oral or tympanic) and sustained for at least 3 days only assessed in participants who experienced a fever within 1 day of enrollment up to Day 28.
Outcome measures
| Measure |
Camostat Mesilate
n=18 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=5 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Time to Fever Resolution
|
3 Days
Interval 2.0 to 8.0
|
1 Days
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Day 1, Day 7 and Day 15Number of participants with no viral shedding (yes/no) using reverse transcriptase-polymerase chain reaction (RT-PCR) at Day 7, Day 15, and at early termination.
Outcome measures
| Measure |
Camostat Mesilate
n=194 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=101 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Resolution of Viral Shedding
No Viral Shedding at Day 1
|
32 Participants
|
25 Participants
|
|
Resolution of Viral Shedding
No Viral Shedding at Day 7
|
77 Participants
|
36 Participants
|
|
Resolution of Viral Shedding
No Viral Shedding at Day 15
|
136 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
Number of participants with Adverse events (AEs) and Serious adverse events (SAEs) of any grade from randomization up to Day 28.
Outcome measures
| Measure |
Camostat Mesilate
n=195 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=99 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Rate of Adverse Events and Serious Adverse Events
Treatment Emergent Adverse Event (TEAE)
|
17 Participants
|
13 Participants
|
|
Rate of Adverse Events and Serious Adverse Events
Serious TEAEs
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
Cumulative number of participants with grade 3 and 4 AEs from randomization up to Day 28.
Outcome measures
| Measure |
Camostat Mesilate
n=195 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=99 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Cumulative Rate of Grade 3 and 4 Adverse Events
Grade 3 AEs
|
6 Participants
|
0 Participants
|
|
Cumulative Rate of Grade 3 and 4 Adverse Events
Grade 4 AEs
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The Intent-to-Treat (ITT) population includes all subjects who were randomized.
Number of participants that discontinued from study due to an AE/SAE (discontinued participants will be followed up to Day 28).
Outcome measures
| Measure |
Camostat Mesilate
n=194 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=101 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Rate of Discontinuation
|
11 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 15Population: The Intent-to Treat Population includes all subjects who were randomized.
Clinical Laboratory Value of Platelet Count at Day 1 and Day 15
Outcome measures
| Measure |
Camostat Mesilate
n=194 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=101 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Laboratory Parameter - Platelet Count
Day 1 Platelet Count
|
243 10^9 platelets/L
Standard Deviation 71.69
|
252.1 10^9 platelets/L
Standard Deviation 80.45
|
|
Laboratory Parameter - Platelet Count
Day 15 Platelet Count
|
288.3 10^9 platelets/L
Standard Deviation 86.66
|
281.5 10^9 platelets/L
Standard Deviation 83.22
|
SECONDARY outcome
Timeframe: Day 1 and Day 15Clinical laboratory value of Potassium Levels at Day 1 and Day 15
Outcome measures
| Measure |
Camostat Mesilate
n=194 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=101 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Laboratory Parameter - Potassium Level
Day 1 Potassium Level
|
4.26 mmol/L
Standard Deviation 0.397
|
4.23 mmol/L
Standard Deviation 0.391
|
|
Laboratory Parameter - Potassium Level
Day 15 Potassium Level
|
4.30 mmol/L
Standard Deviation 0.363
|
4.29 mmol/L
Standard Deviation 0.407
|
SECONDARY outcome
Timeframe: Day 1 and Day 15Population: The Intent-to-Treat population includes all subjects who were randomized.
Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15
Outcome measures
| Measure |
Camostat Mesilate
n=194 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=101 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Laboratory Parameter - Aspartate Aminotransferase (AST)
Day 1 AST
|
24.6 U/L
Standard Deviation 14.71
|
25.3 U/L
Standard Deviation 12.33
|
|
Laboratory Parameter - Aspartate Aminotransferase (AST)
Day 15 AST
|
21.8 U/L
Standard Deviation 10.18
|
21.8 U/L
Standard Deviation 10.65
|
SECONDARY outcome
Timeframe: Day 1 and Day 15Population: The Intent-to-Treat population includes all subjects who were randomized.
Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15
Outcome measures
| Measure |
Camostat Mesilate
n=194 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=101 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Laboratory Parameter - Alanine Aminotransferase (ALT)
Day 1 ALT
|
30.2 U/L
Standard Deviation 27.58
|
29.0 U/L
Standard Deviation 17.01
|
|
Laboratory Parameter - Alanine Aminotransferase (ALT)
Day 15 ALT
|
27.9 U/L
Standard Deviation 20.1
|
27.9 U/L
Standard Deviation 22.28
|
SECONDARY outcome
Timeframe: Day 1 and Day 15Population: The Intent-to-Treat population includes all subjects who were randomized.
Clinical laboratory value of Alkaline Phosphatase (ALP) at Day 1 and Day 15
Outcome measures
| Measure |
Camostat Mesilate
n=194 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=101 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Laboratory Parameter - Alkaline Phosphatase (ALP)
Day 1 ALP
|
76.3 U/L
Standard Deviation 24.44
|
80.5 U/L
Standard Deviation 25.55
|
|
Laboratory Parameter - Alkaline Phosphatase (ALP)
Day 15 ALP
|
77.8 U/L
Standard Deviation 27.60
|
78.6 U/L
Standard Deviation 24.91
|
SECONDARY outcome
Timeframe: Day 1 and Day 15Population: The Intent-to-Treat population includes all subjects who were randomized.
Clinical laboratory value of Gamma-Glutamyl Transferase (GGT) at Day 1 and Day 15
Outcome measures
| Measure |
Camostat Mesilate
n=194 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=101 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Laboratory Parameter - Gamma-Glutamyl Transferase (GGT)
Day 1 GGT
|
33.5 U/L
Standard Deviation 25.61
|
33.4 U/L
Standard Deviation 29.91
|
|
Laboratory Parameter - Gamma-Glutamyl Transferase (GGT)
Day 15 GGT
|
34.1 U/L
Standard Deviation 30.50
|
31.1 U/L
Standard Deviation 20.30
|
SECONDARY outcome
Timeframe: Day 1, Day 7 and Day 15Population: The Intent-to-Treat population includes all subjects who were randomized.
Heart rate at Day 1, Day 7 and Day 15
Outcome measures
| Measure |
Camostat Mesilate
n=194 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=101 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Vital Signs - Heart Rate
Heart rate Day 1
|
81.2 Beats/Minute
Standard Deviation 10.25
|
80.1 Beats/Minute
Standard Deviation 10.48
|
|
Vital Signs - Heart Rate
Heart rate Day 7
|
81.2 Beats/Minute
Standard Deviation 10.07
|
80.5 Beats/Minute
Standard Deviation 9.09
|
|
Vital Signs - Heart Rate
Heart rate Day 15
|
79.8 Beats/Minute
Standard Deviation 10.16
|
79.2 Beats/Minute
Standard Deviation 9.94
|
SECONDARY outcome
Timeframe: Day 1, Day 7 and Day 15Population: The Intent-to-Treat population includes all subjects who were randomized.
Blood pressure (BP) at Day 1, Day 7 and Day 15
Outcome measures
| Measure |
Camostat Mesilate
n=194 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=101 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Vital Signs - Blood Pressure
Systolic BP Day 1
|
128.7 mmHg
Standard Deviation 13.87
|
129.6 mmHg
Standard Deviation 13.97
|
|
Vital Signs - Blood Pressure
Systolic BP Day 7
|
128.2 mmHg
Standard Deviation 16.61
|
129.2 mmHg
Standard Deviation 15.54
|
|
Vital Signs - Blood Pressure
Systolic BP Day 15
|
128.1 mmHg
Standard Deviation 16.61
|
129.2 mmHg
Standard Deviation 15.54
|
|
Vital Signs - Blood Pressure
Diastolic BP Day 1
|
80.7 mmHg
Standard Deviation 8.9
|
80.8 mmHg
Standard Deviation 7.43
|
|
Vital Signs - Blood Pressure
Diastolic BP Day 7
|
80.2 mmHg
Standard Deviation 9.34
|
80.9 mmHg
Standard Deviation 9.6
|
|
Vital Signs - Blood Pressure
Diastolic BP Day 15
|
78.9 mmHg
Standard Deviation 8.72
|
81.3 mmHg
Standard Deviation 10.65
|
SECONDARY outcome
Timeframe: Day 1, Day 7 and Day 15Population: The Intent-to-Treat population includes all subjects who were randomized.
Peripheral Capillary Oxygen Saturation (SpO2) at Day 1, Day 7 and Day 15
Outcome measures
| Measure |
Camostat Mesilate
n=194 Participants
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=101 Participants
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2)
SpO2 Day 15
|
97.6 Percentage of SpO2
Standard Deviation 1.46
|
97.5 Percentage of SpO2
Standard Deviation 2.22
|
|
Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2)
SpO2 Day 1
|
97.3 Percentage of SpO2
Standard Deviation 1.33
|
97.4 Percentage of SpO2
Standard Deviation 1.3
|
|
Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2)
SpO2 Day 7
|
97.3 Percentage of SpO2
Standard Deviation 1.78
|
97.3 Percentage of SpO2
Standard Deviation 1.43
|
Adverse Events
Camostat Mesilate
Serious events: 10 serious events
Other events: 8 other events
Deaths: 1 deaths
Placebo
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Camostat Mesilate
n=195 participants at risk
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=99 participants at risk
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Gastrointestinal disorders
Diarrhea
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
General disorders
Fatigue
|
0.00%
0/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
2.0%
2/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
General disorders
Pyrexia
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Infections and infestations
Pneumonia
|
2.6%
5/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
2.0%
2/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Investigations
Oxygen saturation decreased
|
1.0%
2/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Psychiatric disorders
Delusion
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Renal and urinary disorders
Renal Failure
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
1.0%
2/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
1.0%
1/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
1.0%
1/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Vascular disorders
Hypotension
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
Other adverse events
| Measure |
Camostat Mesilate
n=195 participants at risk
Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.
Camostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
|
Placebo
n=99 participants at risk
Participants will receive placebo for 14 days in addition to standard of care treatment.
Placebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
1.0%
2/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
1.0%
1/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
2.0%
2/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Gastrointestinal disorders
Diarrhea
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
General disorders
Fatigue
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
General disorders
Pyrexia
|
0.00%
0/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
2.0%
2/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Renal and urinary disorders
Renal Failure
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
1.0%
2/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
1.0%
1/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
1.0%
1/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
1.0%
1/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
1.0%
1/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Investigations
Oxygen Saturation Decreased
|
0.00%
0/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
1.0%
1/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Metabolism and nutrition disorders
Decreased apetite
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Nervous system disorders
Aguesia
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
1.0%
1/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Nervous system disorders
Anosmia
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
1.0%
1/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Psychiatric disorders
Anxiety
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Psychiatric disorders
Insomnia
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Nervous system disorders
Migraine
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.51%
1/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
0.00%
0/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
1.0%
1/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
|
Vascular disorders
Hypertension
|
0.00%
0/195 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
1.0%
1/99 • 28 Days
A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).
|
Additional Information
Cynthia Tinkoff, Pharm.D. Manager, Medical Affairs
Sagent Pharmaceuticals, Inc.
Phone: 847-908-6913
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place