Trial Outcomes & Findings for COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Acebilustat Sub-Protocol (NCT NCT04662060)

NCT ID: NCT04662060

Last Updated: 2023-06-13

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 120 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2023-06-13

Participant Flow

Participant milestones

Measure	Placebo Participants receive placebo for 28 days.	Acebilustat Participants receive acebilustat 100 mg for 28 days.
Overall Study STARTED	60	60
Overall Study Received Allocated Treatment	59	59
Overall Study COMPLETED	55	56
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participants with non-missing data

Baseline characteristics by cohort

Measure	Placebo n=60 Participants Participants receive placebo for 28 days.	Acebilustat n=60 Participants Participants receive acebilustat 100 mg for 28 days.	Total n=120 Participants Total of all reporting groups
Age, Continuous	41 years STANDARD_DEVIATION 14 • n=60 Participants	41 years STANDARD_DEVIATION 13 • n=60 Participants	41 years STANDARD_DEVIATION 13 • n=120 Participants
Sex: Female, Male Female	40 Participants n=60 Participants	38 Participants n=60 Participants	78 Participants n=120 Participants
Sex: Female, Male Male	20 Participants n=60 Participants	22 Participants n=60 Participants	42 Participants n=120 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=60 Participants	14 Participants n=60 Participants	28 Participants n=120 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=60 Participants	46 Participants n=60 Participants	91 Participants n=120 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=60 Participants	0 Participants n=60 Participants	1 Participants n=120 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	0 Participants n=60 Participants	1 Participants n=60 Participants	1 Participants n=120 Participants
Race/Ethnicity, Customized Asian	5 Participants n=60 Participants	5 Participants n=60 Participants	10 Participants n=120 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=60 Participants	0 Participants n=60 Participants	1 Participants n=120 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=60 Participants	1 Participants n=60 Participants	3 Participants n=120 Participants
Race/Ethnicity, Customized White	46 Participants n=60 Participants	43 Participants n=60 Participants	89 Participants n=120 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=60 Participants	2 Participants n=60 Participants	3 Participants n=120 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=60 Participants	3 Participants n=60 Participants	4 Participants n=120 Participants
Race/Ethnicity, Customized Other	3 Participants n=60 Participants	5 Participants n=60 Participants	8 Participants n=120 Participants
Race/Ethnicity, Customized Missing	1 Participants n=60 Participants	0 Participants n=60 Participants	1 Participants n=120 Participants
Region of Enrollment United States	60 Participants n=60 Participants	60 Participants n=60 Participants	120 Participants n=120 Participants
Fully Vaccinated	56 Participants n=60 Participants	54 Participants n=60 Participants	110 Participants n=120 Participants
Body Mass Index (BMI)	26.9 kg/m^2 STANDARD_DEVIATION 6.7 • n=60 Participants	26.8 kg/m^2 STANDARD_DEVIATION 5.2 • n=60 Participants	26.8 kg/m^2 STANDARD_DEVIATION 6.0 • n=120 Participants
BMI 30+	12 Participants n=60 Participants	13 Participants n=60 Participants	25 Participants n=120 Participants
Received Monoclonal Antibody Therapy	4 Participants n=60 Participants	5 Participants n=60 Participants	9 Participants n=120 Participants
Seropositivity	39 Participants n=52 Participants • Participants with non-missing data	39 Participants n=55 Participants • Participants with non-missing data	78 Participants n=107 Participants • Participants with non-missing data
Days from Symptom Onset	4 days n=60 Participants	4 days n=60 Participants	4 days n=120 Participants
Viral Shedding	21.2 cycles STANDARD_DEVIATION 5.8 • n=60 Participants	20.5 cycles STANDARD_DEVIATION 6.4 • n=60 Participants	20.8 cycles STANDARD_DEVIATION 6.1 • n=120 Participants

PRIMARY outcome

Timeframe: 28 days

Population: 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 28 days.	Acebilustat n=60 Participants Participants receive acebilustat 100 mg for 28 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

SECONDARY outcome

Timeframe: 10 days

Population: 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 28 days.	Acebilustat n=60 Participants Participants receive acebilustat 100 mg for 28 days.
For the Viral Domain: Change in Viral Shedding	1.6 cycles Interval 1.5 to 1.7	1.7 cycles Interval 1.6 to 1.7

SECONDARY outcome

Timeframe: 28 days

Population: 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 28 days.	Acebilustat n=60 Participants Participants receive acebilustat 100 mg for 28 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

SECONDARY outcome

Timeframe: 28 days

Population: 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 28 days.	Acebilustat n=60 Participants Participants receive acebilustat 100 mg for 28 days.
Time to First Resolution	11.5 days Interval 7.75 to 18.25	14 days Interval 7.0 to 18.0

SECONDARY outcome

Timeframe: 28 days

Population: 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 28 days.	Acebilustat n=60 Participants Participants receive acebilustat 100 mg for 28 days.
Time to Full Resolution	13 days Interval 8.75 to 17.5	15 days Interval 11.0 to 18.0

SECONDARY outcome

Timeframe: 28 days

Population: Intent-to-treat analysis set

Outcome measures

Measure	Placebo n=60 Participants Participants receive placebo for 28 days.	Acebilustat n=60 Participants Participants receive acebilustat 100 mg for 28 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
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
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

SECONDARY outcome

Timeframe: 28 days

Population: Participants with available antibody data are included in the analysis.

Outcome measures

Measure	Placebo n=55 Participants Participants receive placebo for 28 days.	Acebilustat n=53 Participants Participants receive acebilustat 100 mg for 28 days.
Number of Participants That Developed Antibodies to SARS-CoV-2	55 Participants	53 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Acebilustat

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	Placebo n=59 participants at risk Participants receive placebo for 28 days.	Acebilustat n=59 participants at risk Participants receive acebilustat 100 mg for 28 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.

Additional Information

Manesha Desai, PhD

Stanford University

Phone: (650) 725-1946

Email: manisha.desai@stanford.edu

Results disclosure agreements

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