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Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness

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: NCT04337359
Expanded Access Status : Available
First Posted : April 7, 2020
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

The purpose of this Cohort Treatment Plan is to allow access to ruxolitinib for eligible patients diagnosed with severe/very severe COVID-19 illness. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

The requesting Treating Physician submitted a request for access to drug (often referred to as Compassionate Use) to Novartis which was reviewed and approved by the medical team experienced with the drug and indication.

Please refer to the latest Investigator's Brochure (IB) or approved label for overview of ruxolitinib including: non-clinical and clinical experience, risk and benefits. Novartis will continue to provide any new safety information to the Treating Physician as they emerge.


Condition or disease Intervention/treatment
Severe/Very Severe COVID-19 Illness Drug: Ruxolitinib

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Ruxolitinib
    5 mg. Tablet
    Other Name: Jakavi

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:

Written patient informed consent or assent must be obtained prior to start of treatment.

  • Patients aged ≥ 6 years
  • Patients clinically diagnosed with SARS-CoV-2 infection, either through positive serum antibodies (IgM or IgG); or by PCR; or by other approved diagnostic methodology. Patients with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and SARS-CoV-2 test pending) may be included.
  • Adult and adolescent patients (≥12years), who meet one of the below criteria

    • Respiratory frequency ≥ 30/min
    • Oxygen saturation ≤ 93% on room air (FiO2=0.21)
    • Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) <300mmHg(1mmHg=0.133kPa) (corrective formulation should be used for higher altitude regions (over 1000m).

AND

-- Patients with lung imaging showing pulmonary infiltrates (chest X-ray or CT scan)

Pediatric patients (≥6-<12 years) who meet one of the below criteria (where appropriate):

  • Shortness of breath
  • Oxygen saturation <92% on room air (Fi)2=0.21)
  • Labored breathing (e.g. wheezing, flaring of nostrils, three concave sign), cyanosis, intermittent apnea.
  • Lethargy or convulsions
  • Refusal to eat or difficulty with feeding; signs of dehydration

Exclusion Criteria:

  • Patients eligible for this Treatment Plan must not meet any of the following criteria:
  • History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib
  • Presence of severely impaired renal function defined by serum creatinine > 2 mg/dL (>176.8 μmol/L), or have estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation or calculated by the updated bedside Schwartz equation.
  • Pregnant or nursing (lactating) women.
  • Patients who are NOT able to understand and to comply with treatment instructions and requirements unless health care proxy is able to provide consent.

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): NCT04337359


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Indonesia
Novartis Investigative Site Available
Curug, Indonesia
Italy
Novartis Investigative Site Available
Caserta, CE, Italy, 81100
Novartis Investigative Site Available
La Spezia, SP, Italy, 19100
Novartis Investigative Site Available
Cirie, Torino, Italy, 10073
Novartis Investigative Site Available
Torino, Italy, 10149
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04337359    
Other Study ID Numbers: CINC424A2001M
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Corona Virus
Pneumonia
Virus
Covid-19
Covid