Trial Search Results
COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master 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.
- Drug: Acebilustat
- Drug: Camostat
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
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
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
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
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.
12. Additional exclusions may pertain to specific drugs.
Ages Eligible for Study
18 Years - 80 Years
Genders Eligible for Study