COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master Protocol

NCT ID: NCT04662086

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2023-02-02

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.

Detailed Description

The platform study allows investigational products with objectives either: evaluating viral shedding (Virology Domain); and COVID-19 related Clinical Outcomes (Clinical Domain).

The primary objective for investigational products within the Viral Domain is:

A. To evaluate the efficacy of each therapeutic intervention in addition to standard supportive care (SSC) compared with SSC in reducing viral shedding of SARS-CoV-2 virus in outpatients with COVID-19 disease.

The primary objective for investigational products within for the Clinical Domain is:

B. To evaluate the efficacy of each therapeutic intervention in addition to SSC as compared to SSC in improving sustained clinical outcomes in outpatients with COVID-19 disease.

Secondary objectives are:

1. The objective of the non-assigned domain an investigational product is under.

1. If under Clinical Domain, reduction in viral shedding.

2. If under Viral Domain, time to sustained resolution of symptoms.

2. To evaluate the efficacy of each therapeutic intervention in reducing SARS-CoV-2 related hospitalizations, ED visits, or death in outpatients with COVID-19 disease.

3. To assess the development of antibodies against SARS-CoV-2

4. To evaluate the safety and tolerability of each therapeutic intervention compared with placebo (supportive care).

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acebilustat

Participants are randomized to receive either active acebilustat or matching placebo for 28 days.

Group Type: EXPERIMENTAL

Acebilustat

Intervention Type: DRUG

100 mg capsule administered orally once daily

Camostat

Participants are randomized to receive either active camostat or matching placebo for 10 days.

Group Type: EXPERIMENTAL

Camostat

Intervention Type: DRUG

200 mg (2 x 100 mg tablet) administered orally four times daily (800 mg total daily dose).

Interventions

Acebilustat

100 mg capsule administered orally once daily

Intervention Type: DRUG

Camostat

200 mg (2 x 100 mg tablet) administered orally four times daily (800 mg total daily dose).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Outpatient setting

2. Age ≥ 18 years and ≤ 80 years at the time of the assessment

3. Able and willing to understand the study, adhere to all study procedures, and provide written informed consent

4. 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.

5. 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).

6. Participant's COVID-19 related symptom onset occurred within 7 days prior to time of randomization.

Exclusion Criteria

1. At screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission.

2. Previous use of experimental drugs that may be active against COVID-19 in the eyes of the investigators.

3. Participant yields a positive urine pregnancy test at screening.

4. 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.

5. 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).

6. Has renal insufficiency including severe renal impairment and ESRD and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

7. Has liver impairment greater than Child Pugh A.

8. Has a history of alcohol or drug abuse in the previous 6 months.

9. Has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.

10. Has taken another investigational drug within the past 30 days.

11. Is deemed by the Investigator to be ineligible for any reason.

12. Additional exclusions may pertain to specific drugs as described in study-specific protocols.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manisha Desai, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Upinder Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Yvonne Maldonado, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Chaitan Khosla, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Haley Hedlin, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

ValleyCare Medical Center

Pleasanton, California, United States

Stanford University

Stanford, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 34274494 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36996150 (View on PubMed)

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Reference Type: DERIVED

PMID: 34473343 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Master Protocol

View Document

Document Type: Study Protocol and Statistical Analysis Plan: Acebilustat Sub-Protocol

View Document

Document Type: Study Protocol and Statistical Analysis Plan: Camostat Sub-Protocol

View Document

Other Identifiers

COPPS-Master Protocol

Identifier Type: -

Identifier Source: org_study_id