Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness
Latest Information Update: 02 Mar 2021
At a glance
- Drugs Ruxolitinib (Primary) ; Methylprednisolone; Prednisone
- Indications COVID-19 pneumonia; SARS-CoV-2 acute respiratory disease
- Focus Expanded access; Therapeutic Use
- Sponsors Novartis Pharmaceuticals
- 01 Feb 2021 Primary endpoint has been met. (clinical recovery without mechanical ventilation), as per results published in the Leukemia
- 01 Feb 2021 Results published in the Leukemia
- 22 Jan 2021 Status changed from recruiting to completed.
Most Recent Events
Trial Overview
Outcome
Purpose
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.
Primary Endpoints
clinical recovery without mechanical ventilation [1]
admission to ICU for mechanical ventilation
death
Other Endpoints
reduction of the inflammatory response
defined as absence of fever and at least a 30% decrease of CRP levels at the second clinical observation—i.e., 3–10 days after hospital admission [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
COVID-19 pneumonia | treatment | severe |
SARS-CoV-2 acute respiratory disease | treatment | severe |
Subjects
- Subject Type patients
-
Number
Actual: 75
- Sex male & female
- Age Group ≥ 18 years; adult; elderly
Patient 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
Patient 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.
Trial Details
Identifiers
Identifier | Owner |
---|---|
NCT04337359 | ClinicalTrials.gov: US National Institutes of Health |
CINC424A2001M | Novartis |
Organisations
- Sponsors Novartis Pharmaceuticals
- Affiliations Novartis Pharmaceuticals
Trial Dates
Other Details
- Design multicentre; prospective
- Phase of Trial Clinical Phase Unknown
- Location Indonesia; Italy
- Focus Expanded access; Therapeutic Use
Interventions
Drugs | Route | Formulation |
---|---|---|
Methylprednisolone | Intravenous |
-
|
Prednisone | Oral |
-
|
RuxolitinibPrimary Drug | Oral | Tablet |
Drug: Ruxolitinib (5 mg. Tablet) Other Name: Jakavi
Ruxolitinib
at a dose of 5 mg twice daily for 7 days and then tapered to 5 mg daily to complete a 10-day course of treatment.
methyl-prednisolone 1 mg/kg intravenously for 3 days followed by 0.5 mg/kg for 5 days, then oral prednisone, which was slowly tapered in the course of 2 weeks
Results
Publications
-
D'Alessio A, Del Poggio P, Bracchi F, Cesana G, Sertori N, Di Mauro D, et al. Low-dose ruxolitinib plus steroid in severe SARS-CoV-2 pneumonia. Leukemia 2021;35(2):635-638.
PubMed | CrossRef Fulltext
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Novartis Pharmaceuticals
41613241111
show details
novartis.email@novartis.com |
Novartis Pharmaceuticals |
-
|
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
Novartis Investigative Site | Caserta, CE | Italy |
Novartis Investigative Site | Cirie, Torino | Italy |
Novartis Investigative Site | Curug | Indonesia |
Novartis Investigative Site | La Spezia, SP | Italy |
Novartis Investigative Site | Torino | Italy |
Novartis Pharmaceuticals |
-
|
-
|
Trial History
Event Date | Event Type | Comment |
---|---|---|
01 Feb 2021 | Endpoint met | Primary endpoint has been met. (clinical recovery without mechanical ventilation), as per results published in the Leukemia Updated 02 Mar 2021 |
01 Feb 2021 | Results | Results published in the Leukemia Updated 02 Mar 2021 |
29 Jan 2021 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 29 Jan 2021 |
22 Jan 2021 | Status change - completed | Status changed from recruiting to completed. Updated 29 Jan 2021 |
09 Apr 2020 | New trial record | New trial record Updated 09 Apr 2020 |
Table of Contents
References
-
D'Alessio A, Del Poggio P, Bracchi F, Cesana G, Sertori N, Di Mauro D, et al. Low-dose ruxolitinib plus steroid in severe SARS-CoV-2 pneumonia. Leukemia 2021;35(2):635-638.
PubMed | CrossRef Fulltext -
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov
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