Trial Outcomes & Findings for Camostat With Bicalutamide for COVID-19 (NCT NCT04652765)
NCT ID: NCT04652765
Last Updated: 2023-10-06
Results Overview
Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
up to 28 days
Results posted on
2023-10-06
Participant Flow
Participant milestones
| Measure |
Standard of Care (SOC)
SARS-CoV-2 positive participants will receive SOC therapy alone.
|
SOC Plus Camostat
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
|
SOC Plus Camostat and Bicalutamide
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
Bicalutamide 150 mg: Bicalutamide 150mg by mouth once daily, for a total of 7 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
3
|
|
Overall Study
COMPLETED
|
1
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Camostat With Bicalutamide for COVID-19
Baseline characteristics by cohort
| Measure |
Standard of Care (SOC)
n=1 Participants
SARS-CoV-2 positive participants will receive SOC therapy alone.
|
SOC Plus Camostat
n=2 Participants
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
|
SOC Plus Camostat and Bicalutamide
n=3 Participants
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
Bicalutamide 150 mg: Bicalutamide 150mg by mouth once daily, for a total of 7 days
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
61 years
n=99 Participants
|
62.5 years
n=107 Participants
|
61 years
n=206 Participants
|
61.5 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 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
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: up to 28 daysNumber of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28
Outcome measures
| Measure |
Standard of Care (SOC)
n=1 Participants
SARS-CoV-2 positive participants will receive SOC therapy alone.
|
SOC Plus Camostat
n=2 Participants
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
|
SOC Plus Camostat and Bicalutamide
n=3 Participants
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
Bicalutamide 150 mg: Bicalutamide 150mg by mouth once daily, for a total of 7 days
|
|---|---|---|---|
|
Number of Participants Requiring Hospitalization
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 21 daysOutcome measures
| Measure |
Standard of Care (SOC)
n=1 Participants
SARS-CoV-2 positive participants will receive SOC therapy alone.
|
SOC Plus Camostat
n=2 Participants
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
|
SOC Plus Camostat and Bicalutamide
n=2 Participants
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
Bicalutamide 150 mg: Bicalutamide 150mg by mouth once daily, for a total of 7 days
|
|---|---|---|---|
|
Number of Participants Experiencing Symptoms
|
1 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 60 daysNumber of adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)
Outcome measures
| Measure |
Standard of Care (SOC)
n=1 Participants
SARS-CoV-2 positive participants will receive SOC therapy alone.
|
SOC Plus Camostat
n=2 Participants
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
|
SOC Plus Camostat and Bicalutamide
n=2 Participants
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
Bicalutamide 150 mg: Bicalutamide 150mg by mouth once daily, for a total of 7 days
|
|---|---|---|---|
|
Number of Drug-related Adverse Events
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 60 daysNumber of serious adverse events, as defined by NCI CTCAE version 5.0, that are related to the study drug (or therapy)
Outcome measures
| Measure |
Standard of Care (SOC)
n=1 Participants
SARS-CoV-2 positive participants will receive SOC therapy alone.
|
SOC Plus Camostat
n=2 Participants
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
|
SOC Plus Camostat and Bicalutamide
n=2 Participants
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
Bicalutamide 150 mg: Bicalutamide 150mg by mouth once daily, for a total of 7 days
|
|---|---|---|---|
|
Number of Drug-related Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 60 daysNumber of participants deceased.
Outcome measures
| Measure |
Standard of Care (SOC)
n=1 Participants
SARS-CoV-2 positive participants will receive SOC therapy alone.
|
SOC Plus Camostat
n=2 Participants
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
|
SOC Plus Camostat and Bicalutamide
n=2 Participants
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
Bicalutamide 150 mg: Bicalutamide 150mg by mouth once daily, for a total of 7 days
|
|---|---|---|---|
|
All-cause Mortality
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 60 daysNumber of calendar days in the hospital
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 60 daysOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 60 daysNumber of calendar days in IMC unit
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 60 daysOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 60 daysNumber of calendar days in ICU
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 60 daysOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 60 daysNumber of calendar days requiring mechanical ventilation
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care (SOC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SOC Plus Camostat
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SOC Plus Camostat and Bicalutamide
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care (SOC)
n=1 participants at risk
SARS-CoV-2 positive participants will receive SOC therapy alone.
|
SOC Plus Camostat
n=2 participants at risk
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
|
SOC Plus Camostat and Bicalutamide
n=3 participants at risk
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.
Camostat Mesilate: Camostat 600mg by mouth four times a day, for a total of 7 days
Bicalutamide 150 mg: Bicalutamide 150mg by mouth once daily, for a total of 7 days
|
|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • 60 days
Only non COVID-19 adverse event were collected
|
0.00%
0/2 • 60 days
Only non COVID-19 adverse event were collected
|
33.3%
1/3 • Number of events 1 • 60 days
Only non COVID-19 adverse event were collected
|
Additional Information
Cathy Handy Marshall
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 4109550231
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place