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

NCT04662060 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: COPPS-Acebilustat
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this study is to efficiently evaluate the clinical efficacy and safety of different investigational therapeutics among adults who have COVID-19 but are not yet sick enough to require hospitalization. The overall hypothesis is that through an adaptive trial design, potential effective therapies (single and combination) may be identified for this group of patients. COVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding (Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the platform, every investigational product will collect data for both Domain primary endpoints. Individual treatments to be evaluated in the platform will be described in separate sub-protocols.

Conditions

Covid19

Keywords

Outpatient

Outcome Measures

Primary Outcomes (1)

• For Clinical Domain: Time-to-sustained-resolution

  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.

  28 days

Secondary Outcomes (6)

• For the Viral Domain: Change in Viral Shedding

  10 days

• Time to Viral Cessation

  28 days

• Time to First Resolution

  28 days

• Time to Full Resolution

  28 days

• Number of Participants With SARS-CoV-2 Related Hospitalizations, Emergency Department (ED) Visits, or Death in Outpatients With COVID-19 Disease.

  28 days

Study Arms (2)

Acebilustat

EXPERIMENTAL

Participants are randomized to receive acebilustat for 28 days.

Drug: Acebilustat

Matching Placebo

PLACEBO COMPARATOR

Participants are randomized to receive placebo to match acebilustat for 28 days.

Drug: Placebo

Interventions

Acebilustat DRUG

100 mg capsule administered orally once daily

Acebilustat

Placebo DRUG

Placebo to match acebilustat administered orally once daily

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient setting
• Age ≥ 18 years and ≤ 80 years at the time of the assessment
• Able and willing to understand the study, adhere to all study procedures, and provide written informed consent
• Initial diagnosis of COVID-19 disease as defined by an FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 with no more than 72 hours from the initial swab used in the diagnosis to the time of commencing informed consent.
• At baseline, at least two symptoms should have mild or higher severity score, where at least one of the mild symptoms is not cough, fatigue, or loss of smell/taste OR at least one symptom has a moderate or higher severity score on the COVID Outpatient Symptom Scale (COSS).
• Participant's COVID-19 related symptom onset occurred within 7 days prior to time of randomization.

You may not qualify if:

• At screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission.
• Previous use of experimental drugs that may be active against COVID-19 in the eyes of the investigators.
• Participant yields a positive urine pregnancy test at screening.
• Participant is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers).
• NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19.
• Participant has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus \[HIV\], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).
• Has renal insufficiency including severe renal impairment and ESRD and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
• Has liver impairment greater than Child Pugh A.
• Has a history of alcohol or drug abuse in the previous 6 months.
• Has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
• Has taken another investigational drug within the past 30 days.
• Is deemed by the Investigator to be ineligible for any reason.
• Patient has abnormal liver enzyme tests at screening, including AST or ALT ≥3 × the upper limit of normal (ULN) or total bilirubin \>1.25 × ULN at Screening (patients with known Gilbert's syndrome can be included with bilirubin \>1.25 × ULN).
• Patient is pregnant or breastfeeding.
• Patients with baseline ALT \>1.5 × ULN.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• Bunning B, Hedlin H, Purington N, Sundaram V, Kapphahn K, Weng Y, Cunanan K, Maldonado Y, Singh U, Khosla C, O'Hara R, Nicolls M, Springman E, Parsonnet J, Rogers A, Levitt J, Desai M. The COVID-19 Outpatient Pragmatic Platform Study (COPPS): Study design of a multi-center pragmatic platform trial. Contemp Clin Trials. 2021 Sep;108:106509. doi: 10.1016/j.cct.2021.106509. Epub 2021 Jul 16.

  PMID: 34274494 BACKGROUND

• Levitt JE, Hedlin H, Duong S, Lu D, Lee J, Bunning B, Elkarra N, Pinsky BA, Heffernan E, Springman E, Moss RB, Bonilla HF, Parsonnet J, Zamanian RT, Langguth JJ, Bollyky J, Khosla C, Nicolls MR, Desai M, Rogers AJ. Evaluation of Acebilustat, a Selective Inhibitor of Leukotriene B4 Biosynthesis, for Treatment of Outpatients With Mild-Moderate Coronavirus Disease 2019: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. Clin Infect Dis. 2023 Jul 26;77(2):186-193. doi: 10.1093/cid/ciad187.

  PMID: 36996150 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

acebilustat

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Manesha Desai, PhD
• Organization: Stanford University

manisha.desai@stanford.edu

(650) 725-1946

Study Officials

• Angela Rogers, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Joseph Levitt, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 10, 2020
• Study Start: April 23, 2021
• Primary Completion: May 3, 2022
• Study Completion: February 2, 2023
• Last Updated: June 13, 2023
• Results First Posted: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)