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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355793
Expanded Access Status : Available
First Posted : April 21, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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
COVID-19 Drug: Ruxolitinib

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: An Open-Label Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Ruxolitinib
    Ruxolitinib starting dose level 5 mg orally, twice daily (BID).
    Other Name: INCB018424

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
  • 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..

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355793


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com

Sponsors and Collaborators
Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04355793    
Other Study ID Numbers: INCB 18424-MA-COVID-19-301
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Keywords provided by Incyte Corporation:
SARS-CoV-2
Cytokine Storm
ruxolitinib
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes