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IRAK4 Inhibition in Treatment of COVID-19 With ARDS (I-RAMIC)

NCT04575610 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-10-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PF-06650833

Subjects randomized to the PF-06650833 arm of the study will receive 200 mg IR suspension formulation every 6 hours (via nasogastric \[NG\] tube, orogastric \[OG\] tube, or equivalent) if unable to take tablets by mouth (PO). Subjects for whom concomitant administration of a strong inhibitor of cytochrome P450 (CYP) 3A4 will have the dose of the IR formulation to 200 mg once daily (QD). Subjects who can take tablets PO will receive 400 mg PF-06650833 (2-200 mg tablets) of the MR formulation QD under fasted conditions (preferably at least 4 hours after and 1.5 hours before a meal). No dose adjustment is needed for subjects taking the MR tablet preparation, except if co-administered with ritonavir in which case the dose should be reduced to 200 mg MR QD. All dosing of PF-06650833 will be in addition to current hospital SOC therapy.

DRUG

Placebo

Matching placebo tablets will be administered.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Hyung Chun, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-27
Primary Completion
2021-10-06
Completion
2021-10-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT04575610 on ClinicalTrials.gov