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COVID-19

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

Incyte Study ID:
INCB 18424-MA-COVID-19-301
CT.gov ID:
NCT04355793
Eudra ID:
N/A
EU CT Number:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Other
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Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • COVID-19
  • PRODUCT
  • Drug: Ruxolitinib
  • COLLABORATORS
    N/A
    DATE
    N/A - Invalid Date
    TYPE
    Expanded Access
    PHASE
    N/A
    SEX
    Female & Male
    AGE
    12+ years
    ACCEPTS HEALTHY VOLUNTEERS
    N/A

    Clinical Study Locations

    No locations found.

    Key Inclusion and Exclusion Criteria

    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.

    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.

    Protocol Summary

    Incyte Study ID:
    INCB 18424-MA-COVID-19-301
    Primary Purpose:
    N/A
    Allocation:
    N/A
    Study Design:
    N/A
    Masking:
    N/A
    Interventions:
  • Drug: Ruxolitinib
  • Enrollment:
    N/A
    Primary Outcome
    Open
    Not Available
    Secondary Outcome
    Open
    Not Available
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