Trial · NCT04662086
COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master Protocol
NCT04662086, Phase 2, Completed, Stanford University; results first posted 2023-05-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master Protocol. Trials, record NCT04662086. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04662086
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master Protocol
- NCT number
- NCT04662086
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 122 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Covid19
- Interventions
- Acebilustat, Camostat
- First posted
- 2020-12-10
- Last updated
- 2023-06-28
- Results first posted
- 2023-05-30
- Limitations and caveats
- This camostat arm did not meet its planned enrollment and did not achieve statistical power as specified in the protocol.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | For Viral Domain: Change in Viral Shedding | 10 days | 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. |
| Primary | For Clinical Domain: Time-to-sustained-resolution | 28 days | 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. |
| Secondary | Time to Viral Cessation | 28 days | Defined as the time in days from randomization to the first of two consecutive negative RT-PCR results of self-collected nasal swabs. |
| Secondary | Time to First Resolution | 28 days | 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. |
| Secondary | Time to Full Resolution | 28 days | Defined as the study day where no symptoms are first self-reported. |
| Secondary | Number of Participants With SARS-CoV-2 Related Hospitalizations, Emergency Department (ED) Visits, or Death in Outpatients With COVID-19 Disease. | 28 days | |
| Secondary | Number of Participants That Developed Antibodies to SARS-CoV-2 | 28 days |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | For Viral Domain: Change in Viral Shedding | 10 days | Intent-to-treat analysis set | cycles | MEAN |
| PRIMARY | For Clinical Domain: Time-to-sustained-resolution | 28 days | Intent-to-treat analysis set | days | MEDIAN |
| SECONDARY | Time to Viral Cessation | 28 days | Intent-to-treat analysis set. | days | MEDIAN |
| SECONDARY | Time to First Resolution | 28 days | Intent-to-treat analysis set | days | MEDIAN |
| SECONDARY | Time to Full Resolution | 28 days | Intent-to-treat analysis set | days | MEDIAN |
| SECONDARY | Number of Participants With SARS-CoV-2 Related Hospitalizations, Emergency Department (ED) Visits, or Death in Outpatients With COVID-19 Disease. | 28 days | Intent-to-treat analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants That Developed Antibodies to SARS-CoV-2 | 28 days | Participants with available antibody data are included in the analysis. No antibody results data were collected in the Camostat arm. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| For Viral Domain: Change in Viral Shedding | Placebo | 1.6 | 95% Confidence Interval 1.5 to 1.7 | cycles | |
| For Viral Domain: Change in Viral Shedding | Acebilustat | 1.7 | 95% Confidence Interval 1.6 to 1.7 | cycles | |
| For Viral Domain: Change in Viral Shedding | Camostat | 1.0 | 95% Confidence Interval 0.4 to 1.6 | cycles | |
| For Clinical Domain: Time-to-sustained-resolution | Placebo | 26 | Inter-Quartile Range 17.5 to NA | days | |
| For Clinical Domain: Time-to-sustained-resolution | Acebilustat | NA | Inter-Quartile Range 22 to NA | days | |
| For Clinical Domain: Time-to-sustained-resolution | Camostat | NA | Inter-Quartile Range NA to NA | days | |
| Time to Viral Cessation | Placebo | NA | Inter-Quartile Range NA to NA | days | |
| Time to Viral Cessation | Acebilustat | NA | Inter-Quartile Range NA to NA | days | |
| Time to Viral Cessation | Camostat | NA | Inter-Quartile Range NA to NA | days | |
| Time to First Resolution | Placebo | 11.5 | Inter-Quartile Range 7.75 to 18.25 | days |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 60 | |
| Overall Study | STARTED | Acebilustat | 60 | |
| Overall Study | STARTED | Camostat | 2 | |
| Overall Study | Received Allocated Treatment | Placebo | 59 | |
| Overall Study | Received Allocated Treatment | Acebilustat | 59 | |
| Overall Study | Received Allocated Treatment | Camostat | 2 | |
| Overall Study | COMPLETED | Placebo | 55 | |
| Overall Study | COMPLETED | Acebilustat | 56 | |
| Overall Study | COMPLETED | Camostat | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 59 | |
| other | Nausea | Gastrointestinal disorders | Acebilustat | 1 | 59 | |
| other | Nausea | Gastrointestinal disorders | Camostat | 0 | 2 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 59 |
| Total, all-cause mortality | Acebilustat | 0 | 59 |
| Total, all-cause mortality | Camostat | 0 | 2 |
| Total, other adverse events | Placebo | 3 | 59 |
| Total, other adverse events | Acebilustat | 1 | 59 |
| Total, other adverse events | Camostat | 0 | 2 |
| Total, serious adverse events | Placebo | 0 | 59 |
| Total, serious adverse events | Acebilustat | 0 | 59 |
| Total, serious adverse events | Camostat | 0 | 2 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04662086
GET https://conductscience.org/api/trials/v1/NCT04662086/results?page=2