IRAK4 Inhibition in Treatment of COVID-19 With ARDS (I-RAMIC)
NCT04575610
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Descriptive Information | |||||||||
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Brief Title ICMJE | IRAK4 Inhibition in Treatment of COVID-19 With ARDS (I-RAMIC) | ||||||||
Official Title ICMJE | Investigation of IRAK4 Inhibition to Mitigate the Impact of COVID-19 in Severe SARS-CoV-2 (I-RAMIC) | ||||||||
Brief Summary | The purpose of this study is to assess the efficacy of PF-06650833 in addition to standard-of-care compared to standard-of-care treatment alone in improving outcomes in patients with COVID-19. | ||||||||
Detailed Description | Proposed is a randomized, double-blind, placebo-controlled, parallel group Phase 2 study of the efficacy and safety of PF-06650833, an investigational drug, in hospitalized adult male and female patients with SARS-CoV-2-induced ARDS who need mechanical ventilation. The primary objective of this study is to assess the efficacy of PF-06650833 in addition to standard-of-care compared to standard-of-care treatment alone in improving outcomes in patients with COVID-19, evidence of increased inflammation, and ARDS requiring mechanical ventilation or extracorporeal membrane oxygenation at time of admission. The secondary objectives of this study are to evaluate:
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | ||||||||
Condition ICMJE | COVID-19 | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 68 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | March 31, 2021 | ||||||||
Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | INCLUSION CRITERIA
EXCLUSION CRITERIA
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04575610 | ||||||||
Other Study ID Numbers ICMJE | 2000028042 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Hyung Chun, Yale University | ||||||||
Study Sponsor ICMJE | Yale University | ||||||||
Collaborators ICMJE | Pfizer | ||||||||
Investigators ICMJE |
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PRS Account | Yale University | ||||||||
Verification Date | December 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |