Trial Outcomes & Findings for COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master Protocol (NCT NCT04662086)
NCT ID: NCT04662086
Last Updated: 2023-06-28
Results Overview
Change in shedding of SARS-CoV-2 virus through day 10 attained from self-collected nasal swab. Viral load (nucleic acid) was assessed by RT-PCR Ct over time, and is reported here as the average change in Ct values per day. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to \~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.
COMPLETED
PHASE2
122 participants
10 days
2023-06-28
Participant Flow
Participant milestones
| Measure |
Placebo
Participants receive placebo for 10 or 28 days.
|
Acebilustat
Participants receive acebilustat (100 mg/day) for 28 days.
|
Camostat
Participants receive camostat (800 mg/day) for 10 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
2
|
|
Overall Study
Received Allocated Treatment
|
59
|
59
|
2
|
|
Overall Study
COMPLETED
|
55
|
56
|
1
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master Protocol
Baseline characteristics by cohort
| Measure |
Placebo
n=60 Participants
Participants receive placebo for 10 or 28 days.
|
Acebilustat
n=60 Participants
Participants receive acebilustat (100 mg/day) for 28 days.
|
Camostat
n=2 Participants
Participants receive camostat (800 mg/day) for 10 days.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 14 • n=5 Participants
|
41 years
STANDARD_DEVIATION 13 • n=7 Participants
|
29 years
STANDARD_DEVIATION 6 • n=5 Participants
|
41 years
STANDARD_DEVIATION 13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Viral Shedding
|
21.2 cycles
STANDARD_DEVIATION 5.8 • n=5 Participants
|
20.5 cycles
STANDARD_DEVIATION 6.4 • n=7 Participants
|
30.8 cycles
STANDARD_DEVIATION 13.1 • n=5 Participants
|
21.0 cycles
STANDARD_DEVIATION 6.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: Intent-to-treat analysis set
Change in shedding of SARS-CoV-2 virus through day 10 attained from self-collected nasal swab. Viral load (nucleic acid) was assessed by RT-PCR Ct over time, and is reported here as the average change in Ct values per day. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to lower viral copy numbers. For reference, Ct values of 20 correspond to \~2.12 x 106 viral copies per milliliter, while a Ct value of 40 is undetectable and is considered the lower limit of detection of this RT-PCR test for SARS-CoV-2.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants receive placebo for 10 or 28 days.
|
Acebilustat
n=60 Participants
Participants receive acebilustat (100 mg/day) for 28 days.
|
Camostat
n=2 Participants
Participants receive camostat (800 mg/day) for 10 days.
|
|---|---|---|---|
|
For Viral Domain: Change in Viral Shedding
|
1.6 cycles
Interval 1.5 to 1.7
|
1.7 cycles
Interval 1.6 to 1.7
|
1.0 cycles
Interval 0.4 to 1.6
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Intent-to-treat analysis set
Time from randomization to sustained symptom resolution assessed over a 28-day period. 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
| Measure |
Placebo
n=60 Participants
Participants receive placebo for 10 or 28 days.
|
Acebilustat
n=60 Participants
Participants receive acebilustat (100 mg/day) for 28 days.
|
Camostat
n=2 Participants
Participants receive camostat (800 mg/day) for 10 days.
|
|---|---|---|---|
|
For Clinical Domain: Time-to-sustained-resolution
|
26 days
Interval 17.5 to
Not calculable due to insufficient number of events
|
NA days
Interval 22.0 to
Not calculable due to insufficient number of events
|
NA days
Not calculable due to insufficient number of events
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Intent-to-treat analysis set.
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
| Measure |
Placebo
n=60 Participants
Participants receive placebo for 10 or 28 days.
|
Acebilustat
n=60 Participants
Participants receive acebilustat (100 mg/day) for 28 days.
|
Camostat
n=2 Participants
Participants receive camostat (800 mg/day) for 10 days.
|
|---|---|---|---|
|
Time to Viral Cessation
|
NA days
Not calculable due to insufficient number of events
|
NA days
Not calculable due to insufficient number of events
|
NA days
Not calculable due to insufficient number of events
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Intent-to-treat analysis set
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
| Measure |
Placebo
n=60 Participants
Participants receive placebo for 10 or 28 days.
|
Acebilustat
n=60 Participants
Participants receive acebilustat (100 mg/day) for 28 days.
|
Camostat
n=2 Participants
Participants receive camostat (800 mg/day) for 10 days.
|
|---|---|---|---|
|
Time to First Resolution
|
11.5 days
Interval 7.75 to 18.25
|
14 days
Interval 7.0 to 18.0
|
NA days
Not calculable due to insufficient number of events
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Intent-to-treat analysis set
Defined as the study day where no symptoms are first self-reported.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants receive placebo for 10 or 28 days.
|
Acebilustat
n=60 Participants
Participants receive acebilustat (100 mg/day) for 28 days.
|
Camostat
n=2 Participants
Participants receive camostat (800 mg/day) for 10 days.
|
|---|---|---|---|
|
Time to Full Resolution
|
13 days
Interval 8.75 to 17.5
|
15 days
Interval 11.0 to 18.0
|
NA days
Not calculable due to insufficient number of events
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Intent-to-treat analysis set
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants receive placebo for 10 or 28 days.
|
Acebilustat
n=60 Participants
Participants receive acebilustat (100 mg/day) for 28 days.
|
Camostat
n=2 Participants
Participants receive camostat (800 mg/day) for 10 days.
|
|---|---|---|---|
|
Number of Participants With SARS-CoV-2 Related Hospitalizations, Emergency Department (ED) Visits, or Death in Outpatients With COVID-19 Disease.
Hospitalization
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With SARS-CoV-2 Related Hospitalizations, Emergency Department (ED) Visits, or Death in Outpatients With COVID-19 Disease.
ED visit
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With SARS-CoV-2 Related Hospitalizations, Emergency Department (ED) Visits, or Death in Outpatients With COVID-19 Disease.
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Participants with available antibody data are included in the analysis. No antibody results data were collected in the Camostat arm.
Outcome measures
| Measure |
Placebo
n=55 Participants
Participants receive placebo for 10 or 28 days.
|
Acebilustat
n=53 Participants
Participants receive acebilustat (100 mg/day) for 28 days.
|
Camostat
Participants receive camostat (800 mg/day) for 10 days.
|
|---|---|---|---|
|
Number of Participants That Developed Antibodies to SARS-CoV-2
|
55 Participants
|
53 Participants
|
—
|
Adverse Events
Placebo
Acebilustat
Camostat
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=59 participants at risk
Participants receive placebo for 10 or 28 days.
|
Acebilustat
n=59 participants at risk
Participants receive acebilustat (100 mg/day) for 28 days.
|
Camostat
n=2 participants at risk
Participants receive camostat (800 mg/day) for 10 days.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.1%
3/59 • Up to 35 days
Safety Analysis Set: per protocol, the safety analysis was performed using the as-treated population and includes all patients who received study treatment. As pre-specified in the study protocol, any clinical events related to the progression of COVID-19 (except death) would not be considered adverse events.
|
1.7%
1/59 • Up to 35 days
Safety Analysis Set: per protocol, the safety analysis was performed using the as-treated population and includes all patients who received study treatment. As pre-specified in the study protocol, any clinical events related to the progression of COVID-19 (except death) would not be considered adverse events.
|
0.00%
0/2 • Up to 35 days
Safety Analysis Set: per protocol, the safety analysis was performed using the as-treated population and includes all patients who received study treatment. As pre-specified in the study protocol, any clinical events related to the progression of COVID-19 (except death) would not be considered adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place