Status:
COMPLETED
COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Acebilustat Sub-Protocol
Lead Sponsor:
Stanford University
Conditions:
Covid19
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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 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).
- Participant's COVID-19 related symptom onset occurred within 7 days prior to time of randomization.
- Other inclusion criteria specific to the investigational product that may, in the eyes of the investigator, be deemed necessary.
Exclusion
- At screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission.
- Previous use of experimental drugs that may be active against COVID-19 in the eyes of the investigators.
- Participant yields a positive urine pregnancy test at screening.
- 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.
- 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).
- Has renal insufficiency including severe renal impairment and ESRD and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
- Has liver impairment greater than Child Pugh A.
- Has a history of alcohol or drug abuse in the previous 6 months.
- Has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
- Has taken another investigational drug within the past 30 days.
- Is deemed by the Investigator to be ineligible for any reason.
- Additional exclusion criteria for acebilustat protocol:
- 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).
- Patient is pregnant or breastfeeding.
- Patients with baseline ALT \>1.5 × ULN.
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04662060
Start Date
April 23 2021
End Date
February 2 2023
Last Update
June 13 2023
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305