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

Trial Profile

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

Status: Completed
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 01 Feb 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
  • Most Recent Events

    • 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.

Trial Overview

Outcome

Primary endpoint met - positive

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

Met on 01 Feb 2021

clinical recovery without mechanical ventilation [1]

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

  1. 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

Authors

Author Total Publications First Author Last Author
Borra G 1 - 1
Bracchi F 1 - -
Cesana G 1 - -
D'Alessio A 1 1 -
Del Poggio P 1 - -
Di Mauro D 1 - -
Fargnoli A 1 - -
Giacomini M 1 - -
Giussani C 1 - -
Moro P 1 - -
Motta M 1 - -
Sertori N 1 - -
Vitale G 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Novartis Pharmaceuticals
41613241111
novartis.email@novartis.com
show details
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

References

  1. 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
  2. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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