Ruxolitinib in the Treatment of Covid-19

NCT04414098 | Unknown Phase 2

• 1 other identifier: CZabala
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

COVID-19

Keywords

Ruxolitinib; Covid-19; SARS

Outcome Measures

Primary Outcomes (1)

• 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)

  during 14 days after the commencement of treatment

Secondary Outcomes (6)

• Evaluate the median duration of hospitalization.

  after 45 days of commencement of treatment.

• Evaluate the evolution of systemic inflammation parameters.

  after 45 days of commencement of treatment.

• Evaluate COVID-19 mortality rate

  after 45 days of treatment.

• Evaluate the proportion of the requirement of mechanical ventilation.

  with a total follow-up of 45 days

• Evaluate ruxolitinib adverse reactions

  with a total follow-up of 45 days.

Interventions

INC424 / Ruxolitinib DRUG

1. 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.

Also known as: Jakavi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Marcelo Iastrebner: lead
• Novartis: collaborator

Related Publications (7)

• 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; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/

  PMID: 32150360 BACKGROUND

• McGonagle 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.

  PMID: 32251717 BACKGROUND

• Banerjee 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.

  PMID: 28255960 BACKGROUND

• Zhou 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.

  PMID: 32194980 BACKGROUND

• Slostad 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.

  PMID: 29134683 BACKGROUND

• Harrison 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.

  PMID: 27211272 BACKGROUND

• Gadina 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.

  PMID: 30806710 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Marcelo Iastrebner, MD

CONTACT

+5491169816300; miastrebner@gmail.com

Joaquin Castro, MD

CONTACT

+5491153880811; drjoaquincastro@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Experimental, open-label, prospective, single center, add-on (added to the standard treatment) study, compared with an historical control arm.

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2020
• Primary Completion: August 15, 2020
• Study Completion: September 15, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06