Trial Outcomes & Findings for Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19 (NCT NCT04470544)
NCT ID: NCT04470544
Last Updated: 2024-11-12
Results Overview
To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will change the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
28 Days
Results posted on
2024-11-12
Participant Flow
Participant milestones
| Measure |
Placebo + Standard of Care
Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo.
|
Camostat + Standard of Care
Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
46
|
44
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Placebo + Standard of Care
Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo.
|
Camostat + Standard of Care
Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
Baseline Characteristics
Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19
Baseline characteristics by cohort
| Measure |
Placebo
n=50 Participants
Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo.
|
Camostat
n=50 Participants
Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 18.4 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 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
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
81 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: All patients that submitted day 28 outcome data
To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will change the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
Outcome measures
| Measure |
Placebo
n=46 Participants
Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo.
|
Camostat
n=43 Participants
Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
|
|---|---|---|
|
Proportion of Patients Alive and Free From Respiratory Failure
|
.891 Proportion of patients
|
.884 Proportion of patients
|
SECONDARY outcome
Timeframe: 28 DaysPopulation: All patients that submitted day 28 outcome data
To determine if reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with SOC treatment will change the proportion of patients alive and free of ventilator use or ECMO at Day 28 as compared to SOC treatment combined with placebo.
Outcome measures
| Measure |
Placebo
n=46 Participants
Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo.
|
Camostat
n=43 Participants
Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
|
|---|---|---|
|
Proportion of Patients Alive and Free of Ventilator Use or ECMO
|
.891 Proportion of patients
|
.883 Proportion of patients
|
SECONDARY outcome
Timeframe: 28 DaysPopulation: All patients that submitted day 28 outcome data
To determine if the combination of Camostat mesilate combined with SOC treatment will result in a changed mortality rate at 28 days as compared to SOC treatment combined with placebo.
Outcome measures
| Measure |
Placebo
n=46 Participants
Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo.
|
Camostat
n=43 Participants
Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
|
|---|---|---|
|
Mortality Rate
|
.061 proportion of participants
|
.070 proportion of participants
|
SECONDARY outcome
Timeframe: 28 DaysClinical change will be defined as a 2 or more point decease on the WHO ordinal scale. The WHO ordinal scale ranges from 0, the best status, to 8, death. Time to clinical improvement will be calculated as the number of days from study entry until the earliest date of clinical change.
Outcome measures
| Measure |
Placebo
n=46 Participants
Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo.
|
Camostat
n=44 Participants
Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
|
|---|---|---|
|
Clinical Change
|
4 Days
Interval 3.0 to 5.0
|
4 Days
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: 28 daysPopulation: All treated patients that were evaluated for adverse events.
Analyses for safety will include all participants who are randomized and received at least 1 dose of study treatment. Participants will be grouped according to the treatment to which they were randomized.
Outcome measures
| Measure |
Placebo
n=46 Participants
Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo.
|
Camostat
n=44 Participants
Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
|
|---|---|---|
|
Adverse Event Grade 3 Plus Rate
|
.17 proportion of participants
|
.20 proportion of participants
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 16 other events
Deaths: 4 deaths
Camostat
Serious events: 2 serious events
Other events: 21 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Placebo
n=50 participants at risk
Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo.
|
Camostat
n=50 participants at risk
Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
|
|---|---|---|
|
General disorders
Death NOS
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Infections and infestations
Infections and infestations - Oth spec
|
4.0%
2/50 • Number of events 2 • 56 days
|
0.00%
0/50 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
2/50 • Number of events 2 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
Other adverse events
| Measure |
Placebo
n=50 participants at risk
Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo.
|
Camostat
n=50 participants at risk
Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
0.00%
0/50 • 56 days
|
4.0%
2/50 • Number of events 3 • 56 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/50 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/50 • Number of events 1 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Cardiac disorders
Heart failure
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Gastrointestinal disorders
Constipation
|
4.0%
2/50 • Number of events 2 • 56 days
|
8.0%
4/50 • Number of events 4 • 56 days
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/50 • Number of events 1 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
General disorders
Chills
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
General disorders
Edema face
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
General disorders
Edema limbs
|
0.00%
0/50 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
General disorders
Fatigue
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
General disorders
Fever
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/50 • Number of events 1 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
General disorders
Pain
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Immune system disorders
Allergic reaction
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Infections and infestations
Herpes simplex reactivation
|
2.0%
1/50 • Number of events 1 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Infections and infestations
Sepsis
|
0.00%
0/50 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Infections and infestations
Shingles
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Infections and infestations
Sinusitis
|
2.0%
1/50 • Number of events 2 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Infections and infestations
Upper respiratory infection
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Infections and infestations
Vaginal infection
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Injury, poisoning and procedural complications
Fracture
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
1/50 • Number of events 1 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Investigations
Weight gain
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Metabolism and nutrition disorders
Alkalosis
|
2.0%
1/50 • Number of events 1 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/50 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.0%
1/50 • Number of events 1 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.0%
1/50 • Number of events 1 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
4/50 • Number of events 4 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/50 • Number of events 1 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Nervous system disorders
Anosmia
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Nervous system disorders
Dizziness
|
2.0%
1/50 • Number of events 1 • 56 days
|
6.0%
3/50 • Number of events 3 • 56 days
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/50 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Nervous system disorders
Paresthesia
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/50 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Nervous system disorders
Seizure
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Psychiatric disorders
Agitation
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Psychiatric disorders
Delirium
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/50 • Number of events 1 • 56 days
|
6.0%
3/50 • Number of events 3 • 56 days
|
|
Psychiatric disorders
Irritability
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/50 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.00%
0/50 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • Number of events 1 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.0%
3/50 • Number of events 3 • 56 days
|
6.0%
3/50 • Number of events 3 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/50 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.0%
2/50 • Number of events 2 • 56 days
|
0.00%
0/50 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
2.0%
1/50 • Number of events 1 • 56 days
|
8.0%
4/50 • Number of events 7 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/50 • Number of events 1 • 56 days
|
6.0%
3/50 • Number of events 3 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.0%
1/50 • Number of events 1 • 56 days
|
0.00%
0/50 • 56 days
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.0%
3/50 • Number of events 3 • 56 days
|
0.00%
0/50 • 56 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/50 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/50 • 56 days
|
2.0%
1/50 • Number of events 1 • 56 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.00%
0/50 • 56 days
|
6.0%
3/50 • Number of events 3 • 56 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/50 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/50 • 56 days
|
4.0%
2/50 • Number of events 2 • 56 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place