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

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ClinicalTrials.gov Identifier: NCT04662060
Recruitment Status : Not yet recruiting
First Posted : December 10, 2020
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

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.


Condition or disease Intervention/treatment Phase
Covid19 Drug: Acebilustat Drug: Placebo Phase 2

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 the duration of 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 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, time to cessation of viral shedding.
    2. If under Viral Domain, time to 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: COVID-19 Outpatient Pragmatic Platform Study (COPPS): A Pragmatic Multi-arm, Adaptive, Phase 2, Blinded, Randomized Placebo-controlled Platform Trial to Assess the Efficacy of Different Investigational Therapeutics in Reducing Time to Disease Resolution or Viral Load Cessation, as Compared to Standard Supportive Care in Outpatients With COVID-19
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Experimental: Acebilustat
Participants are randomized to receive acebilustat
Drug: Acebilustat
100-mg capsule administered orally once daily

Placebo Comparator: Matching Placebo
Participants are randomized to receive placebo to match acebilustat
Drug: Placebo
Placebo to match acebilustat administered orally once daily




Primary Outcome Measures :
  1. For Viral Domain:Time until cessation of shedding of SARS-CoV-2 virus [ Time Frame: 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

  2. For Clinical Domain: Time from randomization to sustained symptom resolution assessed over a 28-day period [ Time Frame: 28 days ]
    Resolution is defined as the first study day where no symptoms are self-reported for 48 hours, not including sense of taste or smell, and defining recovery for fatigue and cough as mild or none. Participants who never experienced resolution will be censored at their last survey completion day.


Secondary Outcome Measures :
  1. Time to first resolution [ Time Frame: 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.

  2. Indicator of SARS-CoV-2 related hospitalizations, ED visits, or death in outpatients with COVID-19 disease. [ Time Frame: 28 days ]
  3. Indicator participant has developed antibodies to SARS-CoV-2 [ Time Frame: 28 days ]
  4. Time to event from randomization to worsening of symptoms or disease progression [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. We rely on Stanford's assay, which was issued an Emergency Use Authorization (EUA number is EUA200036).
  5. At baseline, at least two symptoms should have moderate or higher severity score on the COVID Outpatient Symptom Scale (COSS)
  6. Additional inclusion criteria may pertain to specific drugs as described in study specific protocols.

Exclusion Criteria:

  1. At screening, the subject needs to be admitted to the hospital or is being evaluated for potential admission.
  2. Previous use of drugs that may be active against COVID-19 in the eyes of the investigators.
  3. Subject has any of the following abnormal laboratory test results at screening:

    1. Platelet count <100,000 cells/mm3
    2. Absolute leukocyte count < 500 cells/mm3
    3. Hemoglobin <11 g/dL for women and <12 g/dL for men
    4. Serum creatinine concentration ≥1.5× ULN
    5. Confirmed creatinine clearance (CrCl) < 50 mL/min by Cockcroft-Gault
  4. Subject 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. Subject 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 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.

Additional exclusion criteria for acebilustat protocol:

  1. Patient has abnormal liver enzyme tests at screening, including AST or ALT ≥3 × the ULN or total bilirubin >1.25 x ULN at Screening (patients with known Gilbert's syndrome can be included with bilirubin >1.25 x ULN).
  2. Patient is pregnant or breastfeeding.
  3. Patients with baseline ALT > 1.5X the upper limit of normal (ULN)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662060


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Angela Rogers, MD Stanford University
Principal Investigator: Joseph Levitt, MD, MS Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04662060    
Other Study ID Numbers: COPPS-Acebilustat
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No