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IRAK 4 Inhibitor (PF-06650833) in Hospitalized Patients With COVID-19 Pneumonia and Exuberant Inflammation.

NCT04933799 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-06-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PF-06650833

PF-06650833 is an investigational, highly potent and selective, reversible inhibitor of IRAK4. IRAK4 is a serine, threonine kinase that is a key intracellular signaling node downstream of the myddosome-associated Toll-Like Receptors (TLR) 1, 2, 4, 5, 6, 7, 8, 9 and 10, and the interleukin (IL)-1 family receptors (IL-1R, IL-18R and IL-33R) that mediate much of the innate immune signaling. As an inhibitor of TLR signaling, PF-06650833 targets a different part of the immune system from the Janus kinase (JAK) inhibitors. Given the partial redundancy of innate immune signaling through IRAK4-independent TLR pathways and the lack of direct suppression of T- and B-cell signaling, PF-06650833 is unlikely to lead to exaggerated immunosuppression.

DRUG

Matching Placebo

Placebo will match the study drug in dose, formulation, route and frequency.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Giovanni Franchin, M.D, Ph.D

    lead OTHER

Principal Investigators

  • Giovanni Franchin, M.D, Ph.D · Bronx-Lebanon Hospital Center Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-06
Primary Completion
2022-03-06
Completion
2022-05-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04933799 on ClinicalTrials.gov