Severe/Very Severe COVID-19 IllnessNCT04337359
Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness
A study testing Ruxolitinib in people with Severe/Very Severe COVID-19 Illness, run by Novartis Pharmaceuticals.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 90 years
- Conditions the study is for
- Severe/Very Severe COVID-19 Illness
- What is being tested?
- Ruxolitinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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.
About this study
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.
- Conditions
- Severe/Very Severe COVID-19 Illness
- Being tested
- Ruxolitinib
- Keywords
- Corona Virus, Pneumonia, Virus, Covid-19, Covid
- Medical subject headings
- Pneumonia, Virus Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called Jakavi
5 mg. Tablet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe/Very Severe COVID-19 IllnessStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis is the Marketing Authorization Holder for Jakavi outside the US.
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337359
- Sponsor's protocol ID
- CINC424A2001M
- Status last verified
- Jan 2021
- First submitted
- 3 Apr 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
Publications
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.
PubMed 34937556D'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.
PubMed 33173161
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness
- ClinicalTrials.gov ID
- NCT04337359
- Acronym / sponsor ID
- CINC424A2001M
- Conditions
- Severe/Very Severe COVID-19 Illness
- Keywords
- Corona Virus, Pneumonia, Virus, Covid-19, Covid
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Novartis is the Marketing Authorization Holder for Jakavi outside the US.
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 6 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibAlso: Jakavi5 mg. Tablet | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Derived from this study: PubMed 34937556Stanevich 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.
- Derived from this study: PubMed 33173161D'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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A study testing Ruxolitinib in people with Severe/Very Severe COVID-19 Illness, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04337359, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.