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IRAK4 Inhibitor
IRAK 4 Inhibitor (PF-06650833) in Hospitalized Patients With COVID-19 Pneumonia and Exuberant Inflammation.
Phase 2
Waitlist Available
Research Sponsored by Giovanni Franchin, M.D, Ph.D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 61 days
Summary
The aim of the current clinical study is to evaluate the efficacy and safety of inhibition of Interleukin-1 receptor associated kinase 4 (IRAK4) in ameliorating the proinflammatory state and improving outcomes in severe COVID-19.
Eligible Conditions
- COVID-19
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 61 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~61 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Worsening based on the NIAID Ordinal scale
Secondary study objectives
Change in disease severity based on the NIAID Ordinal scale
Improvement based on the NIAID Ordinal scale
Percentage of subjects in each category of ordinal scale of disease severity
+7 moreOther study objectives
Change from baseline in inflammatory parameters
ICU admission
Pharmacokinetics of PF-06650833
+5 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: PF-06650833 + Standard of Care treatmentActive Control1 Intervention
Subjects randomized to the PF-06650833 arm of the study will receive 400 mg PF-06650833 (2 x 200 mg tablets) of the MR formulation orally QD under fasted conditions (preferably at least 4 hours after and 1.5 hours before a meal). Subjects who cannot take tablets PO will receive PF-06650833 200 mg IR suspension formulation every 6 hours (NG tube or OG tube, or equivalent). Subjects for whom concomitant administration of a strong inhibitor of CYP3A4 (eg, ritonavir) will have the dose reduced to either 200 mg MR or IR QD. All dosing of study drug will be in addition to current hospital SOC treatment that must include treatment targeting SARS-CoV-2.
Group II: Placebo + Standard of Care treatmentPlacebo Group1 Intervention
Placebo will match the Active comparator in dosage form, dosage, frequency and duration.
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Who is running the clinical trial?
Giovanni Franchin, M.D, Ph.DLead Sponsor
PfizerIndustry Sponsor
4,674 Previous Clinical Trials
17,827,153 Total Patients Enrolled
73 Trials studying COVID-19
4,913,895 Patients Enrolled for COVID-19