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

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.

Timeline

Start

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Primary completion

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Completion

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Publications

• Stanevich OV, Fomina DS, Bakulin IG, Galeev SI, Bakin EA, Belash VA, Kulikov AN, Lebedeva AA, Lioznov DA, Polushin YS, Shlyk IV, Vorobyev EA, Vorobyeva SV, Surovceva TV, Bakulina NV, Lysenko MA, Moiseev IS. Ruxolitinib versus dexamethasone in hospitalized adults with COVID-19: multicenter matched cohort study. BMC Infect Dis. 2021 Dec 22;21(1):1277. doi: 10.1186/s12879-021-06982-z.
• D'Alessio A, Del Poggio P, Bracchi F, Cesana G, Sertori N, Di Mauro D, Fargnoli A, Motta M, Giussani C, Moro P, Vitale G, Giacomini M, Borra G. Low-dose ruxolitinib plus steroid in severe SARS-CoV-2 pneumonia. Leukemia. 2021 Feb;35(2):635-638. doi: 10.1038/s41375-020-01087-z. Epub 2020 Nov 10. No abstract available.

Drugs

Indications

No indication recorded.