Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection

December 1, 2021 updated by: Incyte Corporation

An Open-Label Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection

To provide ruxolitinib through an expanded access program for the treatment of cytokine storm due to COVID-19 in the United States to patients who are eligible but not able to be hospitalized or who are hospitalized with a clinical diagnosis and/or positive test for SARD-CoV-2 infection.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, 12 years of age or older.
  • Clinical diagnosis of COVID-19 and/or locally accepted positive test; if feasible, swab should be taken and saved for quantitative testing to determine viral load.
  • Disease severity making the patient eligible for hospitalization (whether or not hospitalization is available), with evidence of cytokine storm as determined by the treating physician. Manifestations of cytokine storm can include the following:
  • Severe shortness of breath (respiratory rate > 24 breaths/minute).
  • SpO2 of < 90% on ambient air.
  • Need for invasive or noninvasive mechanical ventilation.
  • Acute respiratory distress syndrome.
  • Multiple organ failure.
  • Be willing to avoid pregnancy or fathering children
  • Able to provide written informed consent, consent from the patient's legally authorized representative, and/or assent from the patient, parent, or guardian.

Exclusion Criteria:

  • Patients, patient's legally authorized representative, or legal guardians unable to review and sign ICF.
  • Females who are pregnant or breastfeeding, and males and females who cannot comply with requirements to avoid fathering a child or becoming pregnant.
  • Patients with inadequate liver function (ALT above 4 × ULN or direct bilirubin 4 × ULN and the laboratory abnormalities are considered to be due to underlying liver dysfunction).
  • Patients with platelet counts < 50 × 109 /L
  • Any underlying or current medical or psychiatric condition that, in the opinion of the treating physician, would place the patient at an unacceptable risk if he or she were to participate in the program.
  • Previous allergic reactions to JAK inhibitors or excipients.
  • Concomitant use of any other JAK inhibitor.
  • Is eligible or able to access ruxolitinib through an Incyte-sponsored clinical study or is eligible for another therapeutic clinical trial for cytokine storm at the treating institution..

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 18, 2020

First Submitted That Met QC Criteria

April 18, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Actual)

December 15, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 18424-MA-COVID-19-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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