Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Intervention(s):

  • Drug: Acebilustat
  • Drug: Placebo

Phase:

Phase 2

Eligibility


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)

Ages Eligible for Study

18 Years - 80 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305