Trial Outcomes & Findings for The Potential of Camostat in COVID-19 (NCT NCT04625114)

Last Updated: 2024-08-09

Results Overview

The primary endpoint is to assess the efficacy of the drug in terms of change from day 0 to day 5 in respiratory (oropharyngeal swab RT-PCR) surrogate market CT value. Higher values equate to better outcomes.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

108 participants

Primary outcome timeframe

5 days

Results posted on

2024-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Camostat camostat 100mg 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D1-\>D5); Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D6-\>D10);	Placebo Placebo 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D1-\>D5). Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D6-\>D10).
Overall Study STARTED	66	30
Overall Study Initial Treatment Period (D1-D5)	52	25
Overall Study Extension Needed (D6-D10)	9	4
Overall Study COMPLETED	61	29
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Camostat camostat 100mg 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D1-\>D5); Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D6-\>D10);	Placebo Placebo 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D1-\>D5). Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D6-\>D10).
Overall Study Adverse Event	3	1
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

The Potential of Camostat in COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Camostat n=61 Participants camostat 100mg 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D1-\>D5); Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D6-\>D10);	Placebo n=29 Participants Placebo 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D1-\>D5). Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D6-\>D10).	Total n=90 Participants Total of all reporting groups
Age, Continuous	38 years n=99 Participants	37 years n=107 Participants	38 years n=206 Participants
Sex: Female, Male Female	33 Participants n=99 Participants	16 Participants n=107 Participants	49 Participants n=206 Participants
Sex: Female, Male Male	28 Participants n=99 Participants	13 Participants n=107 Participants	41 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	59 Participants n=99 Participants	29 Participants n=107 Participants	88 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Region of Enrollment Belgium	61 participants n=99 Participants	29 participants n=107 Participants	90 participants n=206 Participants

PRIMARY outcome

Timeframe: 5 days

Outcome measures

Outcome measures
Measure	Camostat n=61 Participants camostat 100mg 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D1-\>D5); Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D6-\>D10);	Placebo n=29 Participants Placebo 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D1-\>D5). Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D6-\>D10).
Efficacy in Terms of Viral Load or Surrogate After 5 Days of Treatment	2.34 number of cycles Standard Deviation 10.27	2.08 number of cycles Standard Deviation 11.14

SECONDARY outcome

Timeframe: 28 days

Symptoms were daily measured by means of a self-report questionnaire. The top 5 self-reported symptoms during the whole study period were determined. Time to clinical improvement of these 5 most self-reported symptoms were compared between the camostat and placebo group. Additionally, potential risk factors are studied in order to influence clinical improvement.

Outcome measures

Outcome measures
Measure	Camostat n=61 Participants camostat 100mg 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D1-\>D5); Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D6-\>D10);	Placebo n=29 Participants Placebo 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D1-\>D5). Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D6-\>D10).
Number of Patients With Clinical Improvement (in at Least 1 Point on the 5-point Likert Scale) of 5 Most Self-reported Symptoms	22 Participants	13 Participants

SECONDARY outcome

Timeframe: 28 days

The 50% neutralizing antibody titer (NT50) was compared between the camostat and placebo group

Outcome measures

Outcome measures
Measure	Camostat n=61 Participants camostat 100mg 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D1-\>D5); Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D6-\>D10);	Placebo n=29 Participants Placebo 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D1-\>D5). Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D6-\>D10).
Neutralizing Antibodies (NAbs) at Visit 28 NT50 higher than the detection limit (≥40)	38 Participants	22 Participants
Neutralizing Antibodies (NAbs) at Visit 28 NT50 below the detection limit (<40)	23 Participants	7 Participants

Adverse Events

Camostat

Serious events: 3 serious events

Other events: 59 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Camostat n=61 participants at risk camostat 100mg 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D1-\>D5); Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D6-\>D10);	Placebo n=29 participants at risk Placebo 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D1-\>D5). Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D6-\>D10).
Respiratory, thoracic and mediastinal disorders COVID-19 pneumonia	4.9% 3/61 • Number of events 3 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	3.4% 1/29 • Number of events 1 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.

Other adverse events

Additional Information

Dr Marie-Angélique De Scheerder

University Hospital Ghent

Phone: +32 9 33 21349

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Camostat n=61 participants at risk camostat 100mg 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D1-\>D5); Camostat: Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D6-\>D10);	Placebo n=29 participants at risk Placebo 3 tablets 3x/day D1-\>D5 (+ possible extension D6-\>D10) Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D1-\>D5). Placebo: SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D6-\>D10).
General disorders fatigue	31.1% 19/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	13.8% 4/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.
Metabolism and nutrition disorders change in appetite	14.8% 9/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	6.9% 2/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.
Gastrointestinal disorders diarrhea	11.5% 7/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	13.8% 4/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.
Gastrointestinal disorders nausea	14.8% 9/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	6.9% 2/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.
Nervous system disorders headache	8.2% 5/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	6.9% 2/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.
Gastrointestinal disorders flatulence	6.6% 4/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	0.00% 0/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.
Ear and labyrinth disorders dizziness	4.9% 3/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	0.00% 0/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.
Investigations neutropenia	14.8% 9/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	6.9% 2/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.
Investigations leucopenia	11.5% 7/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	6.9% 2/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.
Investigations CRP increase	6.6% 4/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	6.9% 2/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.
Investigations lymphopenia	6.6% 4/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	6.9% 2/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.
Investigations ALT increase	4.9% 3/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	6.9% 2/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.
Investigations ferritin increase	4.9% 3/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	6.9% 2/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.
Investigations fibrin D dimer increase	4.9% 3/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	6.9% 2/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.
Investigations eosinopenia	3.3% 2/61 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.	3.4% 1/29 • adverse events were recorded from the time the subject has taken at least one dose of study treatment (day 1) through the last visit of this subject (day 28 visit). Patients were selected either based on the presence of symptoms suggestive of COVID-19 disease based on clinical symptoms and signs or any asymptomatic individual that presented with positive screening test. Patients that needed to be hospitalized or had a high risk of hospitalization were not included.