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COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Acebilustat Sub-Protocol
Trial ID: NCT04662060
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.
COVID-19 Outpatient Pragmatic Platform Study (COPPS): A Pragmatic Multi-arm, Adaptive, Phase 2, Blinded, Randomized Placebo-controlled Platform Trial to Assess the Efficacy of Different Investigational Therapeutics in Reducing Time to Disease Resolution or Viral Load Cessation, as Compared to Standard Supportive Care in Outpatients With COVID-19
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
7. Other inclusion criteria specific to the investigational product that may, in the eyes
of the investigator, be deemed necessary.
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
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.
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