Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness
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|ClinicalTrials.gov Identifier: NCT04337359|
Expanded Access Status : Available
First Posted : April 7, 2020
Last Update Posted : May 4, 2020
Novartis is the Marketing Authorization Holder for Jakavi outside the United States
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|
|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|
- Drug: Ruxolitinib
5 mg. TabletOther Name: Jakavi
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
|Contact: Novartis Pharmaceuticalsemail@example.com|
|Contact: Novartis Pharmaeuticals|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|