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The COVID-19 Outpatient Pragmatic Platform Study (COPPS): Study design of a multi-center pragmatic platform trial.
Bunning, Bryan; Hedlin, Haley; Purington, Natasha; Sundaram, Vandana; Kapphahn, Kristopher; Weng, Yingjie; Cunanan, Kristen; Maldonado, Yvonne; Singh, Upinder; Khosla, Chaitan; O'Hara, Ruth; Nicolls, Mark; Springman, Eric; Parsonnet, Julie; Rogers, Angela; Levitt, Joseph; Desai, Manisha.
  • Bunning B; Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, CA, USA.
  • Hedlin H; Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, CA, USA.
  • Purington N; Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, CA, USA.
  • Sundaram V; Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, CA, USA.
  • Kapphahn K; Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, CA, USA.
  • Weng Y; Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, CA, USA.
  • Cunanan K; Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, CA, USA.
  • Maldonado Y; Divison of Infectious Diseases, Department of Pediatrics, Stanford University, Stanford, CA, USA.
  • Singh U; Divison of Infectious Diseases, Department of Medicine, Stanford University, Stanford, CA, USA.
  • Khosla C; Department of Chemical Engineering, Stanford Unviersity, Stanford, CA, USA; Stanford ChEM-H, Stanford University, Stanford, CA, USA.
  • O'Hara R; Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.
  • Nicolls M; Divison of Pulmonary, Allergy & Critical Care Medicine, Department of Medicine, Stanford University, Stanford, CA, USA.
  • Springman E; Illuma Biosciences LLC, Punta Gorda, FL, USA.
  • Parsonnet J; Divison of Infectious Diseases, Department of Medicine, Stanford University, Stanford, CA, USA; Department of Epidemiology and Population Health, Stanford University, Stanford, CA, USA.
  • Rogers A; Divison of Pulmonary, Allergy & Critical Care Medicine, Department of Medicine, Stanford University, Stanford, CA, USA.
  • Levitt J; Divison of Pulmonary, Allergy & Critical Care Medicine, Department of Medicine, Stanford University, Stanford, CA, USA.
  • Desai M; Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, CA, USA. Electronic address: manishad@stanford.edu.
Contemp Clin Trials ; 108: 106509, 2021 09.
Article in English | MEDLINE | ID: covidwho-1312964
ABSTRACT
More than 3000 clinical trials related to COVID-19 have been registered through clinicaltrials.gov. With so many trials, there is a risk that many will be inconclusive due to being underpowered or due to an inability to recruit patients. At academic medical centers, multiple trials are competing for the same resources; the success of one may come at the expense of another. The COVID-19 Outpatient Pragmatic Protocol Study (COPPS) is a flexible phase 2, multi-site, randomized, blinded trial based at Stanford University designed to overcome these issues by simultaneously evaluating multiple COVID-19 treatments in the outpatient setting in one common platform with shared controls. This approach reduces the overall number of patients required for statistical power, while improving the likelihood that any enrolled patient receives active treatment. The platform study has two main domains designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding (Viral Domain), measured with self-collected nasal swabs, or improve clinical outcomes (Clinical Domain), measured through self-reported symptomology data. Data are collected on both domains for all participants enrolled. Participants are followed over a 28-day period. COPPS has the advantage of pragmatism created around its workflow that is also appealing to potential participants because of a lower probability of inactive treatment. At the conclusion of this clinical trial we expect to have identified potentially effective therapeutic strategy/ies for treating COVID-19 in the outpatient setting, which will have a transformative impact on medicine and public health.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Contemp Clin Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article Affiliation country: J.cct.2021.106509

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Contemp Clin Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article Affiliation country: J.cct.2021.106509