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. 2021 Sep 2;2021(9):CD013825. doi: 10.1002/14651858.CD013825.pub2

COPPS.

Methods Drug name: acebilustat, camostat
Trial design: pragmatic, multi‐arm, adaptive, phase 2, blinded, randomised, placebo‐controlled platform trial
Identifiers: NCT04662086
Target sample size: 240 participants
Planned completion date: March 2022
Participants Setting
  • Outpatient

  • USA


Eligibility criteria
  • Inclusion criteria

    • 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 moderate or higher severity score on the COVID Outpatient Symptom Scale (COSS)

    • Additional inclusion criteria may pertain to specific drugs as described in study‐specific protocols

  • Exclusion criteria

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

    • Previous use of drugs that may be active against COVID‐19 in the eyes of the investigators

    • Participant has any abnormal laboratory test results at screening

    • Participantis using adrenocorticosteroids

    • Participant has a serious chronic disease (e.g. uncontrolled HIV, cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency)

    • Has renal insufficiency requiring haemodialysis or continuous ambulatory peritoneal dialysis (CAPD)

    • Has liver impairment greater than Child Pugh A

    • History of alcohol or drug abuse in the previous 6 months, psychiatric disease that is not well controlled

    • Has taken another investigational drug within the past 30 days

    • Is deemed by the Investigator to be ineligible for any reason

Interventions Intervention
  • Acebilustat (100 mg capsule administered orally once daily )

  • Camostat (200 mg tablet administered orally 4 times daily )


Comparator
  • Placebo

Outcomes Efficacy outcomes
  • All‐cause mortality

    • at up to 30 days: planned

    • at up to 60 days: not planned

  • Clinical progression/improvement of symptoms: planned

  • Admission to hospital: planned

  • Length of hospital stay: planned

  • Admission to ICU: not planned

  • Length of ICU stay: not planned

  • Quality of life, including fatigue: not planned

  • Viral clearance: planned


Safety outcomes
  • Number of participants with grade 3 and grade 4 AEs: not planned

  • Number of participants with SAEs: not planned


Additional study outcomes
  • Time from randomisation to sustained symptom resolution assessed over a 28‐day period

  • Time to first resolution

  • Indicator participant has developed antibodies to SARS‐CoV‐2

Notes Funding: Stanford University