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

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