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Ruxolitinib to Combat COVID-19

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ClinicalTrials.gov Identifier: NCT04354714
Recruitment Status : Withdrawn (Could not make FDA required changes)
First Posted : April 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The investigators hypothesize that JAK 1/2 inhibition with ruxolitinib, an FDA approved treatment for intermediate or high-risk myelofibrosis, could have a similar effect in patients with severe COVID-19, quelling the immune-hyperactivation, allowing for clearance of the virus and reversal of the disease manifestations.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Ruxolitinib Procedure: Peripheral blood draw Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Ruxolitinib to Combat COVID-19
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ruxolitinib
-Ruxolitinib is an oral medication that will be given twice daily (BID). Dosing on Days 1 through 3 will be 5 mg BID; dosing on Days 4 through 10 will be 10 mg BID.
Drug: Ruxolitinib
For patients unable to swallow pills, a ruxolitinib suspension will be administered through a nasogastric/orogastric tube
Other Name: Jakafi

Procedure: Peripheral blood draw
-Screening, Day 2, Day 4, Day 8, Day 15, and Day 29




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Through 28 days ]

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Through completion of follow-up (estimated to be 7 months) ]
  2. Length of ICU stay [ Time Frame: Through completion of follow-up (estimated to be 7 months) ]
  3. Duration of ventilator use [ Time Frame: Through completion of follow-up (estimated to be 7 months) ]
  4. Duration of vasopressors use [ Time Frame: Through completion of follow-up (estimated to be 7 months) ]
  5. Duration on renal replacement therapy [ Time Frame: Through completion of follow-up (estimated to be 7 months) ]
  6. Viral kinetics as measured by virologic failure [ Time Frame: Through completion of follow-up (estimated to be 7 months) ]
    -Defined as increase in viral load of >0.5 log on two consecutive days, or >1 log increase in one day, not in keeping with any baseline trend of rising viral loads during the pre-treatment viral testing

  7. Number of adverse events as measured by CTCAE v. 5.0 [ Time Frame: Through completion of follow-up (estimated to be 7 months) ]
  8. Proportion of participants with detectable virus [ Time Frame: Day 5 ]
  9. Proportion of participants with detectable virus [ Time Frame: Day 10 ]
  10. Proportion of participants with detectable virus [ Time Frame: Day 15 ]
  11. Proportion of participants with detectable virus [ Time Frame: Day 29 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of advanced COVID-19 as defined by both of the following:

    • A positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper respiratory tract (nasopharyngeal and oropharyngeal swab) and, if possible, the lower respiratory tract (sputum, tracheal aspirate, or bronchoalveolar lavage), analyzed by a CLIA certified lab
    • Critical disease manifested by any of the following:

      • Chest imaging (CT or chest X-ray permitted) with ≥ 50% lung involvement
      • Respiratory failure requiring invasive mechanical ventilation or supplementary oxygen with FiO2 ≥ 50%
      • Shock (defined as mean arterial pressure ≤ 65 mmHg unresponsive to 25ml/kg isotonic intravenous fluid resuscitation and/or requiring vasopressor support
      • Cardiac dysfunction defined by:

        • New global systolic dysfunction with ejection fraction ≤ 40%
        • Takotsubo cardiomyopathy
        • New onset supraventricular or ventricular arrhythmias
        • Plasma troponin I ≥ 0.10 ng/mL in someone without previously documented troponin elevation beyond that level
        • Elevated plasma NT-proBNP in someone without documented prior elevation

          • If Age < 50, NT-proBNP > 450 pg/ml
          • If Age 50-74, NT-proBNP > 900 pg/ml
          • If Age ≥ 74, NT-proBNP > 1800 pg/ml
  • Receipt of investigational or off-label agents for COVID-19 (prior or ongoing) does not exclude eligibility.
  • Patients who have received autologous or allogeneic stem cell transplant are eligible at the discretion of the investigators.
  • 18 years of age or older at the time of study registration
  • Adequate hematologic function defined as:

    • absolute neutrophil count ≥ 1000/mm3
    • platelet count ≥ 50,000/mm3 without growth factor or transfusion support for 7 days prior to screening
  • Creatinine clearance ≥ 15 mL/minute or receiving renal replacement therapy
  • Women of childbearing potential (defined as women with regular menses, women with amenorrhea, women with irregular cycles, women using a contraceptive method that precludes withdrawal bleeding, or women who have had a tubal ligation) are required to have a negative pregnancy test and use two forms of acceptable contraception, including one barrier method, during participation in the study treatment period.
  • Male patients (if engaging in reproductive sex with a women of childbearing potential) are required to use two forms of acceptable contraception, including one barrier method, during participation in the study and throughout the evaluation period.
  • Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)

Exclusion Criteria:

  • Known allergy or intolerance to ruxolitinib or another JAK inhibitor.
  • Known or suspected active viral (including HIV, hepatitis B, and hepatitis C), bacterial, mycobacterial, or fungal infection other than COVID-19. Virologic testing not required unless infection is suspected.
  • Pregnant and/or breastfeeding.
  • Any uncontrolled intercurrent illness that would put the patient at greater risk or limit compliance with study requirements in the opinion of the investigator.

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): NCT04354714


Sponsors and Collaborators
Washington University School of Medicine
Incyte Corporation
Investigators
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Principal Investigator: John DiPersio, M.D., Ph.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04354714    
Other Study ID Numbers: 04-13-20-DiPersio
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No