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
Eligibility criteria
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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
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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
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Interventions |
Intervention
Comparator
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Outcomes |
Efficacy outcomes
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All‐cause mortality
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
Additional study outcomes
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Notes |
Funding: Stanford University |