Trial · NCT04662060

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

NCT04662060, Phase 2, Completed, Stanford University; results first posted 2023-06-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Acebilustat Sub-Protocol. Trials, record NCT04662060. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04662060

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Acebilustat Sub-Protocol
NCT number: NCT04662060
Status: Completed
Phases: Phase 2
Enrollment: 120 participants, actual
Lead sponsor: Stanford University
Conditions: Covid19
Interventions: Acebilustat, Placebo
First posted: 2020-12-10
Last updated: 2023-06-13
Results first posted: 2023-06-13

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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	For the 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.
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 Clinical Domain: Time-to-sustained-resolution	28 days	Intent-to-treat analysis set	days	MEDIAN
SECONDARY	For the Viral Domain: Change in Viral Shedding	10 days	Intent-to-treat analysis set	cycles	MEAN
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.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
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 the Viral Domain: Change in Viral Shedding	Placebo	1.6	95% Confidence Interval 1.5 to 1.7	cycles
For the Viral Domain: Change in Viral Shedding	Acebilustat	1.7	95% Confidence Interval 1.6 to 1.7	cycles
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 First Resolution	Placebo	11.5	Inter-Quartile Range 7.75 to 18.25	days
Time to First Resolution	Acebilustat	14	Inter-Quartile Range 7 to 18	days
Time to Full Resolution	Placebo	13	Inter-Quartile Range 8.75 to 17.5	days
Time to Full Resolution	Acebilustat	15	Inter-Quartile Range 11 to 18	days

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	60
Overall Study	STARTED	Acebilustat	60
Overall Study	Received Allocated Treatment	Placebo	59
Overall Study	Received Allocated Treatment	Acebilustat	59
Overall Study	COMPLETED	Placebo	55
Overall Study	COMPLETED	Acebilustat	56
Overall Study	NOT COMPLETED	Placebo	5
Overall Study	NOT COMPLETED	Acebilustat	4

Source ClinicalTrials.gov

Adverse events2

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

Source ClinicalTrials.gov

Adverse event totals6

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, other adverse events	Placebo	3	59
Total, other adverse events	Acebilustat	1	59
Total, serious adverse events	Placebo	0	59
Total, serious adverse events	Acebilustat	0	59

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34274494	BACKGROUND	PubMed
36996150	RESULT	PubMed

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 comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Acebilustat vs Placebo: Number of Participants That Developed Antibodies to SARS-CoV-2	Trial comparisons
Acebilustat vs Placebo: deaths from any cause	Trial comparisons
Acebilustat vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04662060

GET https://conductscience.org/api/trials/v1/NCT04662060/registered

API reference For AI assistants