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

Severe/Very Severe COVID-19 Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT04337359
• Other study ID #: CINC424A2001M
• Status: No longer available

Study information

• Verified date: January 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Severe/Very Severe COVID-19 Illness

Intervention

Drug:
• Ruxolitinib
5 mg. Tablet

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Novartis is the Marketing Authorization Holder for Jakavi outside the US.