Cytokine Storm (Covid-19)Phase 3RUXCOVIDNCT04362137
Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm
A Phase 3 study testing Ruxolitinib in people with Cytokine Storm (Covid-19), run by Novartis Pharmaceuticals at 61 sites in 12 countries.
Trial summary
This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 disease. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cytokine Storm (Covid-19)
- What is being tested?
- Ruxolitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 432 participants
- Where
- 61 sitesin 12 countries
- Study dates
- 2 May 2020to 17 Oct 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient or guardian/health proxy must provide informed consent (and assent if applicable) before any study assessment is performed.
- Male and female patients aged ≥ 12 years (or ≥ the lower age limit allowed by Health Authority and/or Ethics Committee/Institutional Review Board approvals).
- Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or another rapid test from the respiratory tract prior to randomization.
- Patients currently hospitalized or will be hospitalized prior to randomization.
- Patients, who meet at least one of the below criteria:
- Pulmonary infiltrates (chest X ray or chest CT scan);
Show all 10Show fewer
- Respiratory frequency ≥ 30/min;
- Requiring supplemental oxygen;
- Oxygen saturation ≤ 94% on room air;
- 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).
Who cannot join
- 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.
- Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
- Currently intubated or intubated between screening and randomization. In intensive care unit (ICU) at time of randomization. Intubated or in ICU for COVID-19 disease prior to screening. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra).
- Unable to ingest tablets at randomization. Pregnant or nursing (lactating) women
Trial locations and contacts
61 sites in 12 countries.
61 sites in 12 countries
United States11 sites
Novartis Investigative Site
Ann Arbor, Michigan, 48109
Novartis Investigative Site
Atlanta, Georgia, 30312
Novartis Investigative Site
Aurora, Colorado, 80045
Novartis Investigative Site
Denver, Colorado, 80205
Novartis Investigative Site
Fullerton, California, 92835
Novartis Investigative Site
Idaho Falls, Idaho, 83404
Novartis Investigative Site
Madison, Wisconsin, 53705-3611
Novartis Investigative Site
Mesquite, Texas, 75149
Novartis Investigative Site
Newark, New Jersey, 07103
Novartis Investigative Site
Seattle, Washington, 98104
Novartis Investigative Site
The Bronx, New York, 10461
Russia9 sites
Novartis Investigative Site
Barnaul, 656045
Novartis Investigative Site
Moscow, 111539
Novartis Investigative Site
Moscow, 123056
Novartis Investigative Site
Ryazan, 390039
Novartis Investigative Site
S-Petersburg, 194354
Novartis Investigative Site
Saint Petersburg, 193312
Novartis Investigative Site
Saint Petersburg, 194044
Novartis Investigative Site
Saint Petersburg, 199106
Novartis Investigative Site
Sestroretsk, 197706
Brazil6 sites
Novartis Investigative Site
Barretos, São Paulo, 14784 400
Novartis Investigative Site
Blumenau, Santa Catarina, 89030101
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 22640-000
Novartis Investigative Site
São Paulo, São Paulo, 01327 001
Novartis Investigative Site
São Paulo, São Paulo, 04502 001
Novartis Investigative Site
Sorocaba, São Paulo
France5 sites
Novartis Investigative Site
Colombes, 92701
Novartis Investigative Site
Eaubonne, 95600
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Pierre-Bénite, 69495
Spain5 sites
Novartis Investigative Site
Badalona, Catalonia, 08916
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Madrid, 28031
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Salamanca, Castille and León, 37007
United Kingdom5 sites
Novartis Investigative Site
Harrow, HA1 3UJ
Novartis Investigative Site
Leeds, LS9 7TF
Novartis Investigative Site
London, SE5 9RS
Novartis Investigative Site
London, WC1E 6HX
Novartis Investigative Site
Manchester, M13 9PL
Peru4 sites
Novartis Investigative Site
Lima, 10
Novartis Investigative Site
Lima, 1
Novartis Investigative Site
San Isidro, Lima region, 27
Novartis Investigative Site
San Miguel, Lima region, 32
Turkey (Türkiye)4 sites
Novartis Investigative Site
Ankara, 06100
Novartis Investigative Site
Istanbul, TUR, 34098
Novartis Investigative Site
Istanbul
Novartis Investigative Site
Yenisehir/Izmir, 35110
Argentina3 sites
Novartis Investigative Site
Buenos Aires, C1426AAM
Novartis Investigative Site
Buenos Aires, C1430BKC
Novartis Investigative Site
C A B A, Buenos Aires, CP1405
Colombia3 sites
Novartis Investigative Site
Barranquilla, Atlántico, 080005
Novartis Investigative Site
Barranquilla
Novartis Investigative Site
Rionegro, Antioquia, 054047
Germany3 sites
Novartis Investigative Site
Lübeck, 23538
Novartis Investigative Site
München, 81377
Novartis Investigative Site
Nuremberg, 90419
Mexico3 sites
Novartis Investigative Site
Estado de México, 52787
Novartis Investigative Site
Mexico City, Mexico City, 14050
Novartis Investigative Site
Mexico City, Mexico CP, 14080
About this study
Official title: Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID)
This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 disease.
Read the detailed description
This was a Phase III, multicenter, double-blind, randomized, placebo-controlled study to assess the efficacy and safety of ruxolitinib in patients aged ≥12 years with COVID-19 disease. The study enrolled patients to ruxolitinib or placebo, in addition to standard of care (SoC) per local practice. Patients who meet the inclusion/exclusion criteria were randomized in a 2:1 ratio to either oral ruxolitinib 5 mg twice daily + SoC or oral matching-image placebo + SoC for a total of 14 days. An additional 14 days of study drug could be given if in the opinion of the investigator the patient's clinical signs and symptoms did not improve, or worsen, and the potential benefit outweighed the potential risk.
The study included:
- Screening period of 0-2 days.
- Study period of 29 days (treatment of 14 days with possible extension of treatment to 28 days).
The primary objective was to evaluate the efficacy (as measured by a composite endpoint of proportion of patients who die, develop respiratory failure [require mechanical ventilation], or require intensive care unit care) of ruxolitinib + standard-of-care (SoC) therapy compared with placebo + SoC therapy, for the treatment of COVID-19 by Day 29.
- Conditions
- Cytokine Storm (Covid-19)
- Being tested
- Ruxolitinib, Placebo
- Keywords
- COVID-19 pneumonia, cytokine release syndrome, SARS-COV-2, ruxolitinib
- Medical subject headings
- Cytokine Release Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called INC424
Ruxolitinib 5 mg tablets
PlaceboDrug
Matching-image placebo
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib 5 mg | Experimental | Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days Receives: Drug: Ruxolitinib |
| Placebo | Placebo comparator | Matching-image placebo for 14 days with possible extension of treatment to 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Who Die, Develop Respiratory Failure [Require Mechanical Ventilation] or Require Intensive Care Unit (ICU) Care
Efficacy is measured by a composite endpoint of proportion of patients who die, develop respiratory failure [require mechanical ventilation], or require intensive care unit [ICU] care for the treatment of COVID-19. Analyses are cumulative, thus analysis on Day 29 includes all events till that day. Patients who developed respiratory failure and/or required ICU at randomization are excluded from the analysis.
Measured: Day 1 - Day 29
Secondary outcomes (13)
Clinical Status
Clinical status is measured with the 9-point ordinal scale.
The scoring is:
- Uninfected patients have a score 0 (no clinical or virological evidence of infection).
- Ambulatory patients (not in hospital or in hospital and ready for discharge) can have a score 1 (no limitation of activities) or 2 (limitation of activities).
- Hospitalized patients with mild disease can have score 3 (no oxygen therapy defined as peripheral oxygen saturation (SpO2) ≥ 94% on room air) or 4 (oxygen by mask or nasal prongs).
- Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)).
- Patients who die have a score 8.
Measured: Baseline, Day 15, Day 29
Percentage of Patients With at Least Two-point Improvement From Baseline in Clinical Status
Percentage of patients with at least two points improvement in clinical status on the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment. Patients with missing data at Day 15 and/or Day 29 are treated as non-responders.
Measured: Baseline, Day 15, Day 29
Percentage of Patients With at Least One-point Improvement From Baseline in Clinical Status
Percentage of patients with at least one point improvement in clinical status on the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment. Patients with missing data at Day 15 and/or Day 29 are treated as non-responders.
Measured: Baseline, Day 15, Day 29
Percentage of Patients With at Least One-point Deterioration From Baseline in Clinical Status
Percentage of patients with at least one point deterioration in clinical status on the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment. Patients with missing data at Day 15 and/or Day 29 are treated as non-responders.
Measured: Baseline, Day 15, Day 29
Time to Improvement in Clinical Status
Time to improvement in clinical status from baseline category to one less severe category of the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment.
Median time to improvement is estimated by Kaplan-Meier method, with dead patients being censored at the maximum follow-up time in the study. Patients who did not achieve improvement and did not die are censored at their last clinical status assessment date.
Measured: 29 days
Mean Change From Baseline in the Clinical Status
Mean change from baseline in the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment. Patients with missing data at Day 15 and/or Day 29 are excluded from the analysis.
A negative change from baseline in the clinical status is a favorable outcome.
Measured: Baseline, Day 15, Day 29
Mortality Rate
Mortality rate is determined as the proportion of participants who died by study Day 15 and Day 29
Measured: Day 15, Day 29
Proportion of Patients Requiring Mechanical Ventilation
Proportion of patients requiring mechanical ventilation. Analyses are cumulative, thus analysis on Day 29 includes all events till that day. Patients who required mechanical ventilation at randomization are excluded from the analysis.
Measured: Day 1 - Day 29
Duration of Hospitalization
Duration of hospitalization is defined as time to hospital discharge. Median time to hospital discharge is estimated by Kaplan-Meier method, with dead patients being censored at the maximum follow-up time in the study. Patients who were not discharged and did not die are censored at their last assessment date.
Measured: 29 days
Time to Hospital Discharge or to a NEWS2 Score of ≤2
The time to hospital discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and maintained for 24 hours whichever comes first.
The NEWS2 is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice presentation or when a patient is being monitored in hospital. The score ranges from 0 (best) to 23 (worst).
Median time is estimated by Kaplan-Meier method, with dead patients being censored at the maximum follow-up time in the study.
Measured: 29 days
Change From Baseline in NEWS2 Score
The National Early Warning Score 2 (NEWS2) is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice presentation or when a patient is being monitored in hospital. The score ranges from 0 (best) to 23 (worst). At each visit, only patients with a value at both baseline and the respective visit are included.
A negative change from baseline in NEWS2 score is a favorable outcome.
Measured: Baseline, Days 3, 5, 8, 11, 15, and 29
Change From Baseline in SpO2/FiO2 Ratio
Change from baseline in peripheral oxygen saturation / fraction of inspired oxygen ratio (SpO2/FiO2 ratio). At each visit, only patients with a value at both baseline and the respective visit are included.
A positive change from baseline in SpO2/FiO2 ratio is a favorable outcome.
Measured: Baseline, Day 15, Day 29
Proportion of Patients With no Oxygen Therapy
Proportion of patients with no oxygen therapy (defined as oxygen saturation ≥ 94% on room air) at Days 15 and 29. Analyses are cumulative, thus analysis on each day includes all events till that day.
Patients with missing data at Day 15 and/or Day 29 are excluded from the analysis.
Measured: Day 15, Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start2 May 2020
- Primary completion17 Oct 2020
- Study completion17 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytokine Storm (Covid-19)Studies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362137
- Sponsor's protocol ID
- CINC424J12301
- Other IDs
- INCB 18424-368, 2020-001662-11
- Acronym
- RUXCOVID
- Status last verified
- Oct 2021
- First submitted
- 22 Apr 2020
- Last updated
- 11 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Han MK, Antila M, Ficker JH, Gordeev I, Guerreros A, Bernus AL, Roquilly A, Sifuentes-Osornio J, Tabak F, Teijeiro R, Bandelli L, Bonagura DS, Shu X, Felser JM, Knorr B, Cao W, Langmuir P, Lehmann T, Levine M, Savic S. Ruxolitinib in addition to standard of care for the treatment of patients admitted to hospital with COVID-19 (RUXCOVID): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Rheumatol. 2022 May;4(5):e351-e361. doi: 10.1016/S2665-9913(22)00044-3. Epub 2022 Mar 29.
PubMed 35368384
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID)
- ClinicalTrials.gov ID
- NCT04362137
- Acronym / sponsor ID
- RUXCOVID / CINC424J12301
- Conditions
- Cytokine Storm (Covid-19)
- Keywords
- COVID-19 pneumonia, cytokine release syndrome, SARS-COV-2, ruxolitinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Incyte Corporation
- Study start
- 2 May 2020 (actual)
- Primary completion
- 17 Oct 2020 (actual)
- Study completion
- 17 Oct 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Posted 2 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 disease.
Detailed description
This was a Phase III, multicenter, double-blind, randomized, placebo-controlled study to assess the efficacy and safety of ruxolitinib in patients aged ≥12 years with COVID-19 disease. The study enrolled patients to ruxolitinib or placebo, in addition to standard of care (SoC) per local practice. Patients who meet the inclusion/exclusion criteria were randomized in a 2:1 ratio to either oral ruxolitinib 5 mg twice daily + SoC or oral matching-image placebo + SoC for a total of 14 days. An additional 14 days of study drug could be given if in the opinion of the investigator the patient's clinical signs and symptoms did not improve, or worsen, and the potential benefit outweighed the potential risk.
The study included:
- Screening period of 0-2 days.
- Study period of 29 days (treatment of 14 days with possible extension of treatment to 28 days).
The primary objective was to evaluate the efficacy (as measured by a composite endpoint of proportion of patients who die, develop respiratory failure [require mechanical ventilation], or require intensive care unit care) of ruxolitinib + standard-of-care (SoC) therapy compared with placebo + SoC therapy, for the treatment of COVID-19 by Day 29.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib 5 mg | Experimental | Drug: RuxolitinibRuxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days |
| Placebo | Placebo comparator | Drug: PlaceboMatching-image placebo for 14 days with possible extension of treatment to 28 days |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patient or guardian/health proxy must provide informed consent (and assent if applicable) before any study assessment is performed.
- Male and female patients aged ≥ 12 years (or ≥ the lower age limit allowed by Health Authority and/or Ethics Committee/Institutional Review Board approvals).
- Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or another rapid test from the respiratory tract prior to randomization.
- Patients currently hospitalized or will be hospitalized prior to randomization.
- Pulmonary infiltrates (chest X ray or chest CT scan);
Key exclusion criteria (5 listed)
- 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.
- Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
- Currently intubated or intubated between screening and randomization. In intensive care unit (ICU) at time of randomization. Intubated or in ICU for COVID-19 disease prior to screening. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra).
- Unable to ingest tablets at randomization. Pregnant or nursing (lactating) women
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: INC424Ruxolitinib 5 mg tablets | Drug | Ruxolitinib 5 mg |
| PlaceboMatching-image placebo | Drug | Placebo |
Primary outcome
Proportion of Patients Who Die, Develop Respiratory Failure [Require Mechanical Ventilation] or Require Intensive Care Unit (ICU) Care
Time frame: Day 1 - Day 29
Efficacy is measured by a composite endpoint of proportion of patients who die, develop respiratory failure [require mechanical ventilation], or require intensive care unit [ICU] care for the treatment of COVID-19. Analyses are cumulative, thus analysis on Day 29 includes all events till that day. Patients who developed respiratory failure and/or required ICU at randomization are excluded from the analysis.
13 secondary outcomes
Clinical Status
Time frame: Baseline, Day 15, Day 29
Percentage of Patients With at Least Two-point Improvement From Baseline in Clinical Status
Time frame: Baseline, Day 15, Day 29
Percentage of Patients With at Least One-point Improvement From Baseline in Clinical Status
Time frame: Baseline, Day 15, Day 29
Percentage of Patients With at Least One-point Deterioration From Baseline in Clinical Status
Time frame: Baseline, Day 15, Day 29
Time to Improvement in Clinical Status
Time frame: 29 days
Mean Change From Baseline in the Clinical Status
Time frame: Baseline, Day 15, Day 29
Mortality Rate
Time frame: Day 15, Day 29
Proportion of Patients Requiring Mechanical Ventilation
Time frame: Day 1 - Day 29
Duration of Hospitalization
Time frame: 29 days
Time to Hospital Discharge or to a NEWS2 Score of ≤2
Time frame: 29 days
Change From Baseline in NEWS2 Score
Time frame: Baseline, Days 3, 5, 8, 11, 15, and 29
Change From Baseline in SpO2/FiO2 Ratio
Time frame: Baseline, Day 15, Day 29
Proportion of Patients With no Oxygen Therapy
Time frame: Day 15, Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35368384Han MK, Antila M, Ficker JH, Gordeev I, Guerreros A, Bernus AL, Roquilly A, Sifuentes-Osornio J, Tabak F, Teijeiro R, Bandelli L, Bonagura DS, Shu X, Felser JM, Knorr B, Cao W, Langmuir P, Lehmann T, Levine M, Savic S. Ruxolitinib in addition to standard of care for the treatment of patients admitted to hospital with COVID-19 (RUXCOVID): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Rheumatol. 2022 May;4(5):e351-e361. doi: 10.1016/S2665-9913(22)00044-3. Epub 2022 Mar 29.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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
61 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ruxolitinib in people with Cytokine Storm (Covid-19), run by Novartis Pharmaceuticals at 61 sites in 12 countries.
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 10 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: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Russia, Brazil, France, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Proportion of Patients Who Die, Develop Respiratory Failure [Require Mechanical Ventilation] or Require Intensive Care Unit (ICU) Care (time frame: Day 1 - Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04362137, which also lists 1 linked publication.
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 11 Oct 2021.