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Key Considerations for Phase 2 or 3 Clinical Study Design of Anti-Inflammatory Agent for COVID-19 Treatment
DC Field | Value | Language |
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dc.contributor.author | Park, Yewon | - |
dc.contributor.author | Na, Joo Young | - |
dc.contributor.author | Cho, Joo-Youn | - |
dc.contributor.author | Oh, Jaeseong | - |
dc.contributor.author | Rhee, Su-jin | - |
dc.date.accessioned | 2022-09-29T03:18:23Z | - |
dc.date.available | 2022-09-29T03:18:23Z | - |
dc.date.created | 2022-07-11 | - |
dc.date.issued | 2022-06 | - |
dc.identifier.citation | Frontiers in Pharmacology, Vol.13, p. 842836 | - |
dc.identifier.issn | 1663-9812 | - |
dc.identifier.uri | https://hdl.handle.net/10371/184641 | - |
dc.description.abstract | Purpose: Current understanding of COVID-19 disease progression suggests a major role for the "cytokine storm" as an important contributor to COVID-19 mortality. To prevent an exaggerated immune response and improve COVID-19 patient endpoints, anti-inflammatory therapeutics have been proposed as clinically useful in severe patients with COVID-19. The purpose of this study was to propose a clinical trial design for the development of anti-inflammatory agents for the treatment of COVID-19, taking into account the physiological and immunological process of COVID-19 and the treatment mechanism of anti-inflammatory agents.Methods: We reviewed and analyzed the guidelines for the development of COVID-19 treatments and the treatment of COVID-19 by regulatory agencies and previously conducted clinical trials on anti-inflammatory drugs for COVID-19. Finally, after discussing with an advisory group, a synopsis was presented for an example protocol for a COVID-19 anti-inflammatory agent phase 2 or 3 study that considers the drug mechanism and the disease progression of COVID-19.Results: A randomized, placebo-controlled, double-blind parallel-group design was suggested as a phase 2 or 3 trial design for developing an anti-inflammatory agent as a COVID-19 treatment. A key item of the example protocol specific to anti-inflammatory agents was the inclusion and exclusion criteria, taking into account the immunosuppressive effects of the drug, clinical time course of COVID-19 disease, and treatment guidelines for COVID-19. Time to recovery is the primary endpoint associated with clinical efficacy and is generally well accepted by many experts.Conclusion: Through this suggested phase 2 or 3 study design of an anti-inflammatory drug for COVID-19, we provide a basis for a study design that can be utilized in clinical development by pharmaceutical companies which are developing a potential anti-inflammatory agent for COVID-19. | - |
dc.language | 영어 | - |
dc.publisher | Frontiers Media S.A. | - |
dc.title | Key Considerations for Phase 2 or 3 Clinical Study Design of Anti-Inflammatory Agent for COVID-19 Treatment | - |
dc.type | Article | - |
dc.identifier.doi | 10.3389/fphar.2022.842836 | - |
dc.citation.journaltitle | Frontiers in Pharmacology | - |
dc.identifier.wosid | 000812113400001 | - |
dc.identifier.scopusid | 2-s2.0-85132814351 | - |
dc.citation.startpage | 842836 | - |
dc.citation.volume | 13 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Cho, Joo-Youn | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
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