COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Acebilustat Sub-Protocol
Condition: Covid19
MeSH terms: COVID-19
Intervention: Acebilustat; Placebo
Intervention description: 100 mg capsule administered orally once daily; Placebo to match acebilustat administered orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Outpatient

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.
    

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.

          7. Other inclusion criteria specific to the investigational product that may, in the eyes
             of the investigator, be deemed necessary.

        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.

        Additional exclusion criteria for acebilustat protocol:

          1. 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).

          2. Patient is pregnant or breastfeeding.

          3. Patients with baseline ALT >1.5 × ULN.