Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness
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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 |
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Expanded Access Status :
Available
First Posted : April 7, 2020
Last Update Posted : July 9, 2020
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| Tracking Information | |||||||||
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| First Submitted Date | April 3, 2020 | ||||||||
| First Posted Date | April 7, 2020 | ||||||||
| Last Update Posted Date | July 9, 2020 | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type | Expanded Access | ||||||||
| Expanded Access Type | Intermediate-size Population | ||||||||
| Intervention | Drug: Ruxolitinib
5 mg. Tablet
Other Name: Jakavi
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Expanded Access Status | Available | ||||||||
| Contacts |
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| Listed Location Countries | Indonesia, Italy | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04337359 | ||||||||
| Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||||||
| Study Sponsor | Novartis Pharmaceuticals | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Novartis | ||||||||
| Verification Date | July 2020 | ||||||||