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

Primary Purpose

Severe/Very Severe COVID-19 Illness

Status

No longer available

Phase

Locations

Study Type

Expanded Access

Intervention

Ruxolitinib

About this trial

This is an expanded access trial for Severe/Very Severe COVID-19 Illness focused on measuring Corona Virus, Pneumonia, Virus, Covid-19, Covid

Eligibility Criteria

6 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT04337359

First Posted

April 3, 2020

Last Updated

January 22, 2021

Sponsor

Novartis Pharmaceuticals

Collaborators

Novartis is the Marketing Authorization Holder for Jakavi outside the US.

1. Study Identification

Unique Protocol Identification Number

NCT04337359

Brief Title

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

Official Title

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

Study Type

Expanded Access

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

No longer available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

Collaborators

Novartis is the Marketing Authorization Holder for Jakavi outside the US.

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe/Very Severe COVID-19 Illness

Keywords

Corona Virus, Pneumonia, Virus, Covid-19, Covid

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ruxolitinib

Other Intervention Name(s)

Jakavi

Intervention Description

5 mg. Tablet

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

34937556

Citation

Stanevich OV, Fomina DS, Bakulin IG, Galeev SI, Bakin EA, Belash VA, Kulikov AN, Lebedeva AA, Lioznov DA, Polushin YS, Shlyk IV, Vorobyev EA, Vorobyeva SV, Surovceva TV, Bakulina NV, Lysenko MA, Moiseev IS. Ruxolitinib versus dexamethasone in hospitalized adults with COVID-19: multicenter matched cohort study. BMC Infect Dis. 2021 Dec 22;21(1):1277. doi: 10.1186/s12879-021-06982-z.

Results Reference

derived

PubMed Identifier

33173161

Citation

D'Alessio A, Del Poggio P, Bracchi F, Cesana G, Sertori N, Di Mauro D, Fargnoli A, Motta M, Giussani C, Moro P, Vitale G, Giacomini M, Borra G. Low-dose ruxolitinib plus steroid in severe SARS-CoV-2 pneumonia. Leukemia. 2021 Feb;35(2):635-638. doi: 10.1038/s41375-020-01087-z. Epub 2020 Nov 10. No abstract available.

Results Reference

derived

Learn more about this trial

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

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