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

Sponsor
Incyte Corporation (Industry)
Overall Status
No longer available
CT.gov ID
NCT04355793
Collaborator
(none)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
An Open-Label Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    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..

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT04355793
    Other Study ID Numbers:
    • INCB 18424-MA-COVID-19-301
    First Posted:
    Apr 21, 2020
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Dec 1, 2021
    Keywords provided by Incyte Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 15, 2021