MedDataX Logo

Trial Outcomes & Findings for COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Camostat Sub-Protocol (NCT NCT04662073)

NCT ID: NCT04662073

Last Updated: 2023-06-28

Results Overview

The number of participants who had viral shedding at Day 10 is reported. Change in shedding of SARS-CoV-2 virus through day 10 attained from self-collected nasal swab RT-PCR data after transformation using a referenced standard curve.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

10 days

Results posted on

2023-06-28

Participant Flow

Participant milestones

Participant milestones
Measure
Camostat
Participants receive camostat 200 mg (2 x 100 mg tablet) orally four times daily for 10 days.
Matching Placebo
Participants receive placebo to match camostat for 10 days.
Overall Study
STARTED
2
0
Overall Study
COMPLETED
1
0
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Camostat
Participants receive camostat 200 mg (2 x 100 mg tablet) orally four times daily for 10 days.
Matching Placebo
Participants receive placebo to match camostat for 10 days.
Overall Study
Withdrawal by Subject
1
0

Baseline Characteristics

COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Camostat Sub-Protocol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Camostat
n=2 Participants
Participants receive camostat 200 mg (2 x 100 mg tablet) orally four times daily for 10 days.
Matching Placebo
Participants receive placebo to match camostat for 10 days.
Total
n=2 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
—
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=5 Participants
—
2 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
—
0 Participants
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
—
1 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
—
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
—
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=5 Participants
—
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
—
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
—
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
—
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
—
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
—
0 Participants
n=5 Participants
Race (NIH/OMB)
White
1 Participants
n=5 Participants
—
1 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
—
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
—
1 Participants
n=5 Participants
Region of Enrollment
United States
2 Participants
n=5 Participants
—
2 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 10 days

Population: No participants were enrolled in the placebo arm.

The number of participants who had viral shedding at Day 10 is reported. Change in shedding of SARS-CoV-2 virus through day 10 attained from self-collected nasal swab RT-PCR data after transformation using a referenced standard curve.

Outcome measures

Outcome measures
Measure
Camostat
n=2 Participants
Participants receive camostat 200 mg (2 x 100 mg tablet) orally four times daily for 10 days.
Matching Placebo
Participants receive placebo to match camostat for 10 days.
For the Viral Domain: Change in Viral Shedding
1 Participants
—

SECONDARY outcome

Timeframe: 28 days

Population: No participants were enrolled in the placebo arm.

The number of participants with sustained resolution by Day 28 is reported. Resolution is defined as the first day where no symptoms are self-reported on all succeeding days through and including day 28, not including sense of taste or smell, and defining recovery for fatigue and cough as mild or none.

Outcome measures

Outcome measures
Measure
Camostat
n=2 Participants
Participants receive camostat 200 mg (2 x 100 mg tablet) orally four times daily for 10 days.
Matching Placebo
Participants receive placebo to match camostat for 10 days.
For Clinical Domain: Time-to-sustained-resolution
2 Participants
—

SECONDARY outcome

Timeframe: 28 days

Population: No participants were enrolled in the placebo arm..

Defined as the time in days from randomization to the first of two consecutive negative RT-PCR results of self-collected nasal swabs.

Outcome measures

Outcome measures
Measure
Camostat
n=2 Participants
Participants receive camostat 200 mg (2 x 100 mg tablet) orally four times daily for 10 days.
Matching Placebo
Participants receive placebo to match camostat for 10 days.
Time to Viral Cessation
NA days
Not calculable due to insufficient number of events
—

SECONDARY outcome

Timeframe: 28 days

Population: No participants were enrolled in the placebo arm.

The number of participants with first resolution by Day 28 is reported. First resolution is defined as the first study day where no symptoms are self-reported, not including sense of taste or smell, and defining recovery for fatigue and cough as mild or none.

Outcome measures

Outcome measures
Measure
Camostat
n=2 Participants
Participants receive camostat 200 mg (2 x 100 mg tablet) orally four times daily for 10 days.
Matching Placebo
Participants receive placebo to match camostat for 10 days.
Time to First Resolution
2 Participants
—

SECONDARY outcome

Timeframe: 28 days

Population: No participants were enrolled in the placebo arm.

The number of participants with full resolution by Day 28 is reported. Full resolution is defined as the study day where no symptoms are first self-reported.

Outcome measures

Outcome measures
Measure
Camostat
n=2 Participants
Participants receive camostat 200 mg (2 x 100 mg tablet) orally four times daily for 10 days.
Matching Placebo
Participants receive placebo to match camostat for 10 days.
Time to Full Resolution
2 Participants
—

SECONDARY outcome

Timeframe: 28 days

Population: No participants were enrolled in the placebo arm.

Count (%) of participants that experienced SARS-CoV-2 a related hospitalization, emergency department (ED) visit, or death.

Outcome measures

Outcome measures
Measure
Camostat
n=2 Participants
Participants receive camostat 200 mg (2 x 100 mg tablet) orally four times daily for 10 days.
Matching Placebo
Participants receive placebo to match camostat for 10 days.
Indicator of SARS-CoV-2 Related Hospitalizations, ED Visits, or Death in Outpatients With COVID-19 Disease.
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 28 days

Population: No antibody results data were collected in the camostat arm, and no participants were enrolled in the placebo arm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 14

Population: Participants with data collected. No participants were enrolled in the placebo arm.

Count (%) of participants with a negative SARS-CoV2 RT-PCR test at day 14

Outcome measures

Outcome measures
Measure
Camostat
n=1 Participants
Participants receive camostat 200 mg (2 x 100 mg tablet) orally four times daily for 10 days.
Matching Placebo
Participants receive placebo to match camostat for 10 days.
Indicator Participant Has a Negative SARS-CoV2 RT-PCR Test
1 Participants
—

SECONDARY outcome

Timeframe: day 28

Population: Participants with data collected. No participants were enrolled in the placebo arm.

Count (%) of participants with a negative SARS-CoV2 RT-PCR test at day 28

Outcome measures

Outcome measures
Measure
Camostat
n=1 Participants
Participants receive camostat 200 mg (2 x 100 mg tablet) orally four times daily for 10 days.
Matching Placebo
Participants receive placebo to match camostat for 10 days.
Indicator Participant Has a Negative SARS-CoV2 RT-PCR Test
1 Participants
—

Adverse Events

Camostat

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Matching Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manesha Desai, PhD

Stanford University

Phone: (650) 725-1946

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place