COVID-19Phase 2NCT04414098
Ruxolitinib in the Treatment of Covid-19
A Phase 2 study testing INC424 / Ruxolitinib in people with COVID-19, run by Marcelo Iastrebner.
Trial summary
The treatment of COVID-19 severe acute respiratory syndrome with ruxolitinib 5 mg orally every 12 hours during 14 days would stop the disproportionate inflammatory response, causing a reduction in the proportion of patients who show a progression and worsening of the severe acute respiratory syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- INC424 / Ruxolitinib
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 15 Sep 2020
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years.
- SARS-Cov2 infection confirmed by a validated method.
- Presence of COVID-19 severe acute respiratory syndrome with:
- Respiratory rate ≥ 20/min O2 saturation ≤93% with FiO2 of 0.21 Lung images by means of computerized tomography or thorax radiography compatible with respiratory involvement due to COVID-19.
- Signed informed consent.
Who cannot join
- Pregnancy or breast-feeding.
- Platelets < 50,000/mm3.
- Neutrophils < 1,000/mm3.
- Hemoglobin < 6 g/dl
- Creatinine ≥2 mg/dl or creatinine clearance ≤30 ml/min.
- Total serum bilirubin > 2.0 x upper limit of normal and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 times the upper limit of normal.
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- Known active infection due to HIV, HVC, HVB, Herpes Zoster or Micob Tuberculosis
- Treatment with Tocilizumab, Baricitinib or Interferon.
- History of hypersensitivity to ruxolitinib or to any medicine with similar chemical compounds
- Patients with mechanical respiratory assistance
- Patients under treatment with Ruxolitinib due to hematological disease
- Any condition that, according to the Investigator, may interfere with the complete participation of the patient in the study, including the administration of the medicinal product, the limitation of visits, the implication of a risk for the patient or that prevents the correct interpretation of the results.
- Treatment Suspension Criteria
- Voluntary decision of the patient
- Treating physician's decision to discontinue the treatment
- Drug toxicity grade 3 or higher (CTCAE 5.0).
- Study Design
- Experimental, open-label, prospective, single center, add-on (added to the standard treatment) study, compared with the historical control arm.
- Control arm: It will include patients with COVID-19 Respiratory Syndrome who meet the aforementioned selection criteria and have received the standard of care (SOC). Efforts will be made so that both arms share similar demographic characteristics as regards gender and age group. Ten centers will participate, which will share the same protocol and their results may be jointly analyzed. The expected n per center is 10-15 patients.
- For the safety assessment as part of the objective, the following parameters will be taken into account:
- Biochemical changes: (day 1, 8 and 14) Leukocytes, Formula, Hemoglobin, platelets, creatinine, glycemia, PT, Bilirubin, GOT/GPT.
- Grade 3/4 Toxicity, SAE (Serious Adverse Event)
- Incidence of discontinuation, suspension or dose-reduction of the study drug.
- Incidence of secondary infections.
- Efficacy Assessment:
- Efficacy will be graded according to the ordinal scale of 8 points.
- Time to Improvement
- Time of response consolidation
- Changes in NEWS table
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy Study of Ruxolitinib in the Treatment of Severe Acute Respiratory Syndrome Due to SARS-COV-2
The treatment of COVID-19 severe acute respiratory syndrome with ruxolitinib 5 mg orally every 12 hours during 14 days would stop the disproportionate inflammatory response, causing a reduction in the proportion of patients who show a progression and worsening of the severe acute respiratory syndrome.
Read the detailed description
Primary Objective
Evaluate the efficacy of ruxolitinib in the treatment of COVID-19 severe acute respiratory syndrome by means of measuring the proportion of patients with clinical worsening (defined by a requirement of FIO2 50% and/or mechanical respiratory assistance) during 14 days after the commencement of treatment.
Secondary Objectives
- Evaluate the median duration of hospitalization. Median duration after 45 days of commencement of treatment.
- Evaluate the evolution of systemic inflammation parameters. Evaluation at the beginning (baseline), middle and end of the treatment with ruxolitinib of PCR, LDH, ESD, Ferritin and IL-6.
- Evaluate COVID-19 mortality rate after 45 days of treatment.
- Evaluate the proportion of the requirement of mechanical ventilation.
- Evaluate ruxolitinib adverse reactions with a total follow-up of 45 days.
- Evaluate the proportion of secondary infections during the treatment with ruxolitinib.
- Conditions
- COVID-19
- Being tested
- INC424 / Ruxolitinib
- Keywords
- Ruxolitinib, Covid-19, SARS
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INC424 / RuxolitinibDrug
Also called Jakavi
- Ruxolitinib 5 mg orally every 12 hours during 14 days.
- Total Follow-up time will be of 45 days.
- The reduction of ruxolitinib dose will be considered in cases of drug-related cytopenias.
- During hospitalization, clinical and laboratory evolution parameters will be recorded daily in the medical history of the patient and in the data collection table of the study. Upon patient's discharge, a follow-up will be conducted until day +45
- During hospitalization, adverse events will be monitored daily by means of clinical assessment and laboratory data.
- After discharge, monitoring of adverse events will continue during the outpatient follow-up.
- Pro-inflammatory parameters will be assessed at baseline, after one week (day +7) and at the end of treatment (day +14)
- Ruxolitinib will be associated to the standard of care for COVID-19 of each center.
- In case of an adverse effect or a need to discontinue the treatment, ruxolitinib should be suspended.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of ruxolitinib in the treatment of COVID-19 severe acute respiratory syndrome
Measuring the proportion of patients with clinical worsening (defined by a requirement of FIO2 >50% and/or mechanical respiratory assistance)
Measured: during 14 days after the commencement of treatment
Secondary outcomes (6)
Evaluate the median duration of hospitalization.
Measured: after 45 days of commencement of treatment.
Evaluate the evolution of systemic inflammation parameters.
Evaluation at the beginning (baseline), middle and end of the treatment with ruxolitinib of PCR, LDH, ESD, Ferritin and IL-6 (if available).
Measured: after 45 days of commencement of treatment.
Evaluate COVID-19 mortality rate
Measured: after 45 days of treatment.
Evaluate the proportion of the requirement of mechanical ventilation.
Measured: with a total follow-up of 45 days
Evaluate ruxolitinib adverse reactions
Measured: with a total follow-up of 45 days.
Evaluate the proportion of secondary infections during the treatment with ruxolitinib
Measured: after 45 days of commencement of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jun 2020 (estimated)
- Primary completion15 Aug 2020 (estimated)
- Study completion15 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental, open-label, prospective, single center, add-on (added to the standard treatment) study, compared with an historical control arm.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marcelo Iastrebner
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor-investigator, Marcelo Iastrebner, Clinica Zabala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414098
- Sponsor's protocol ID
- CZabala
- Status last verified
- Jun 2020
- First submitted
- 29 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
PubMed 32150360McGonagle D, Sharif K, O'Regan A, Bridgewood C. The Role of Cytokines including Interleukin-6 in COVID-19 induced Pneumonia and Macrophage Activation Syndrome-Like Disease. Autoimmun Rev. 2020 Jun;19(6):102537. doi: 10.1016/j.autrev.2020.102537. Epub 2020 Apr 3.
PubMed 32251717Banerjee S, Biehl A, Gadina M, Hasni S, Schwartz DM. JAK-STAT Signaling as a Target for Inflammatory and Autoimmune Diseases: Current and Future Prospects. Drugs. 2017 Apr;77(5):521-546. doi: 10.1007/s40265-017-0701-9.
PubMed 28255960Zhou Y, Hou Y, Shen J, Huang Y, Martin W, Cheng F. Network-based drug repurposing for novel coronavirus 2019-nCoV/SARS-CoV-2. Cell Discov. 2020 Mar 16;6:14. doi: 10.1038/s41421-020-0153-3. eCollection 2020.
PubMed 32194980Slostad J, Hoversten P, Haddox CL, Cisak K, Paludo J, Tefferi A. Ruxolitinib as first-line treatment in secondary hemophagocytic lymphohistiocytosis: A single patient experience. Am J Hematol. 2018 Feb;93(2):E47-E49. doi: 10.1002/ajh.24971. Epub 2017 Dec 4. No abstract available.
PubMed 29134683Harrison CN, Vannucchi AM, Kiladjian JJ, Al-Ali HK, Gisslinger H, Knoops L, Cervantes F, Jones MM, Sun K, McQuitty M, Stalbovskaya V, Gopalakrishna P, Barbui T. Long-term findings from COMFORT-II, a phase 3 study of ruxolitinib vs best available therapy for myelofibrosis. Leukemia. 2016 Aug;30(8):1701-7. doi: 10.1038/leu.2016.148. Epub 2016 May 23.
PubMed 27211272Gadina M, Le MT, Schwartz DM, Silvennoinen O, Nakayamada S, Yamaoka K, O'Shea JJ. Janus kinases to jakinibs: from basic insights to clinical practice. Rheumatology (Oxford). 2019 Feb 1;58(Suppl 1):i4-i16. doi: 10.1093/rheumatology/key432.
PubMed 30806710
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Ruxolitinib in the Treatment of Severe Acute Respiratory Syndrome Due to SARS-COV-2
- ClinicalTrials.gov ID
- NCT04414098
- Acronym / sponsor ID
- CZabala
- Conditions
- COVID-19
- Keywords
- Ruxolitinib, Covid-19, SARS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marcelo IastrebnerUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 4 Jun 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 treatment of COVID-19 severe acute respiratory syndrome with ruxolitinib 5 mg orally every 12 hours during 14 days would stop the disproportionate inflammatory response, causing a reduction in the proportion of patients who show a progression and worsening of the severe acute respiratory syndrome.
Detailed description
Primary Objective
Evaluate the efficacy of ruxolitinib in the treatment of COVID-19 severe acute respiratory syndrome by means of measuring the proportion of patients with clinical worsening (defined by a requirement of FIO2 50% and/or mechanical respiratory assistance) during 14 days after the commencement of treatment.
Secondary Objectives
- Evaluate the median duration of hospitalization. Median duration after 45 days of commencement of treatment.
- Evaluate the evolution of systemic inflammation parameters. Evaluation at the beginning (baseline), middle and end of the treatment with ruxolitinib of PCR, LDH, ESD, Ferritin and IL-6.
- Evaluate COVID-19 mortality rate after 45 days of treatment.
- Evaluate the proportion of the requirement of mechanical ventilation.
- Evaluate ruxolitinib adverse reactions with a total follow-up of 45 days.
- Evaluate the proportion of secondary infections during the treatment with ruxolitinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Experimental, open-label, prospective, single center, add-on (added to the standard treatment) study, compared with an historical control arm.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥ 18 years.
- SARS-Cov2 infection confirmed by a validated method.
- Presence of COVID-19 severe acute respiratory syndrome with:
- Respiratory rate ≥ 20/min O2 saturation ≤93% with FiO2 of 0.21 Lung images by means of computerized tomography or thorax radiography compatible with respiratory involvement due to COVID-19.
- Signed informed consent.
Key exclusion criteria (29 listed)
- Pregnancy or breast-feeding.
- Platelets < 50,000/mm3.
- Neutrophils < 1,000/mm3.
- Hemoglobin < 6 g/dl
- Creatinine ≥2 mg/dl or creatinine clearance ≤30 ml/min.
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 |
|---|---|---|
| INC424 / RuxolitinibAlso: Jakavi1. Ruxolitinib 5 mg orally every 12 hours during 14 days. 2. Total Follow-up time will be of 45 days. 3. The reduction of ruxolitinib dose will be considered in cases of drug-related cytopenias. 4. During hospitalization, clinical and laboratory evolution parameters will be recorded daily in the medical history of the patient and in the data collection table of the study. Upon patient's discharge, a follow-up will be conducted until day +45 5. During hospitalization, adverse events will be monitored daily by means of clinical assessment and laboratory data. 6. After discharge, monitoring of adverse events will continue during the outpatient follow-up. 7. Pro-inflammatory parameters will be assessed at baseline, after one week (day +7) and at the end of treatment (day +14) 8. Ruxolitinib will be associated to the standard of care for COVID-19 of each center. 9. In case of an adverse effect or a need to discontinue the treatment, ruxolitinib should be suspended. | Drug | – |
Primary outcome
Evaluate the efficacy of ruxolitinib in the treatment of COVID-19 severe acute respiratory syndrome
Time frame: during 14 days after the commencement of treatment
Measuring the proportion of patients with clinical worsening (defined by a requirement of FIO2 >50% and/or mechanical respiratory assistance)
6 secondary outcomes
Evaluate the median duration of hospitalization.
Time frame: after 45 days of commencement of treatment.
Evaluate the evolution of systemic inflammation parameters.
Time frame: after 45 days of commencement of treatment.
Evaluate COVID-19 mortality rate
Time frame: after 45 days of treatment.
Evaluate the proportion of the requirement of mechanical ventilation.
Time frame: with a total follow-up of 45 days
Evaluate ruxolitinib adverse reactions
Time frame: with a total follow-up of 45 days.
Evaluate the proportion of secondary infections during the treatment with ruxolitinib
Time frame: after 45 days of commencement of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 32150360Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/
- Background: PubMed 32251717McGonagle D, Sharif K, O'Regan A, Bridgewood C. The Role of Cytokines including Interleukin-6 in COVID-19 induced Pneumonia and Macrophage Activation Syndrome-Like Disease. Autoimmun Rev. 2020 Jun;19(6):102537. doi: 10.1016/j.autrev.2020.102537. Epub 2020 Apr 3.
- Background: PubMed 28255960Banerjee S, Biehl A, Gadina M, Hasni S, Schwartz DM. JAK-STAT Signaling as a Target for Inflammatory and Autoimmune Diseases: Current and Future Prospects. Drugs. 2017 Apr;77(5):521-546. doi: 10.1007/s40265-017-0701-9.
- Background: PubMed 32194980Zhou Y, Hou Y, Shen J, Huang Y, Martin W, Cheng F. Network-based drug repurposing for novel coronavirus 2019-nCoV/SARS-CoV-2. Cell Discov. 2020 Mar 16;6:14. doi: 10.1038/s41421-020-0153-3. eCollection 2020.
- Background: PubMed 29134683Slostad J, Hoversten P, Haddox CL, Cisak K, Paludo J, Tefferi A. Ruxolitinib as first-line treatment in secondary hemophagocytic lymphohistiocytosis: A single patient experience. Am J Hematol. 2018 Feb;93(2):E47-E49. doi: 10.1002/ajh.24971. Epub 2017 Dec 4. No abstract available.
- Background: PubMed 27211272Harrison CN, Vannucchi AM, Kiladjian JJ, Al-Ali HK, Gisslinger H, Knoops L, Cervantes F, Jones MM, Sun K, McQuitty M, Stalbovskaya V, Gopalakrishna P, Barbui T. Long-term findings from COMFORT-II, a phase 3 study of ruxolitinib vs best available therapy for myelofibrosis. Leukemia. 2016 Aug;30(8):1701-7. doi: 10.1038/leu.2016.148. Epub 2016 May 23.
- Background: PubMed 30806710Gadina M, Le MT, Schwartz DM, Silvennoinen O, Nakayamada S, Yamaoka K, O'Shea JJ. Janus kinases to jakinibs: from basic insights to clinical practice. Rheumatology (Oxford). 2019 Feb 1;58(Suppl 1):i4-i16. doi: 10.1093/rheumatology/key432.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INC424 / Ruxolitinib in people with COVID-19, run by Marcelo Iastrebner.
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 5 inclusion and 29 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 4 Jun 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Marcelo Iastrebner, MD (+5491169816300, miastrebner@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of ruxolitinib in the treatment of COVID-19 severe acute respiratory syndrome (time frame: during 14 days after the commencement of treatment). 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 NCT04414098, which also lists 7 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 4 Jun 2020.