Status:
NO_LONGER_AVAILABLE
Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Novartis is the Marketing Authorization Holder for Jakavi outside the US.
Conditions:
Severe/Very Severe COVID-19 Illness
Eligibility:
All Genders
6-90 years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04337359
Last Update
January 26 2021
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