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Ruxolitinib in the Treatment of Covid-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04414098
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Marcelo Iastrebner, Clinica Zabala

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: INC424 / Ruxolitinib Phase 2

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

  1. Evaluate the median duration of hospitalization. Median duration after 45 days of commencement of treatment.
  2. 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.
  3. Evaluate COVID-19 mortality rate after 45 days of treatment.
  4. Evaluate the proportion of the requirement of mechanical ventilation.
  5. Evaluate ruxolitinib adverse reactions with a total follow-up of 45 days.
  6. Evaluate the proportion of secondary infections during the treatment with ruxolitinib.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of Ruxolitinib in the Treatment of Severe Acute Respiratory Syndrome Due to SARS-COV-2
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : September 15, 2020



Intervention Details:
  • Drug: INC424 / Ruxolitinib
    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.
    Other Name: Jakavi


Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Evaluate the median duration of hospitalization. [ Time Frame: after 45 days of commencement of treatment. ]
  2. Evaluate the evolution of systemic inflammation parameters. [ Time Frame: after 45 days of commencement of treatment. ]
    Evaluation at the beginning (baseline), middle and end of the treatment with ruxolitinib of PCR, LDH, ESD, Ferritin and IL-6 (if available).

  3. Evaluate COVID-19 mortality rate [ Time Frame: after 45 days of treatment. ]
  4. Evaluate the proportion of the requirement of mechanical ventilation. [ Time Frame: with a total follow-up of 45 days ]
  5. Evaluate ruxolitinib adverse reactions [ Time Frame: with a total follow-up of 45 days. ]
  6. Evaluate the proportion of secondary infections during the treatment with ruxolitinib [ Time Frame: after 45 days of commencement of treatment. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients ≥ 18 years.
  2. SARS-Cov2 infection confirmed by a validated method.
  3. 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.

  4. Signed informed consent.

Exclusion Criteria:

  1. Pregnancy or breast-feeding.
  2. Platelets < 50,000/mm3.
  3. Neutrophils < 1,000/mm3.
  4. Hemoglobin < 6 g/dl
  5. Creatinine ≥2 mg/dl or creatinine clearance ≤30 ml/min.
  6. 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.
  7. Known active infection due to HIV, HVC, HVB, Herpes Zoster or Micob Tuberculosis
  8. Treatment with Tocilizumab, Baricitinib or Interferon.
  9. History of hypersensitivity to ruxolitinib or to any medicine with similar chemical compounds
  10. Patients with mechanical respiratory assistance
  11. Patients under treatment with Ruxolitinib due to hematological disease
  12. 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

  1. Voluntary decision of the patient
  2. Treating physician's decision to discontinue the treatment
  3. 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:

  1. Biochemical changes: (day 1, 8 and 14) Leukocytes, Formula, Hemoglobin, platelets, creatinine, glycemia, PT, Bilirubin, GOT/GPT.
  2. Grade 3/4 Toxicity, SAE (Serious Adverse Event)
  3. Incidence of discontinuation, suspension or dose-reduction of the study drug.
  4. Incidence of secondary infections.

Efficacy Assessment:

  1. Efficacy will be graded according to the ordinal scale of 8 points.
  2. Time to Improvement
  3. Time of response consolidation
  4. Changes in NEWS table

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414098


Contacts
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Contact: Marcelo Iastrebner, MD +5491169816300 miastrebner@gmail.com
Contact: Joaquin Castro, MD +5491153880811 drjoaquincastro@gmail.com

Sponsors and Collaborators
Marcelo Iastrebner
Novartis
Publications:

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Responsible Party: Marcelo Iastrebner, Principal Investigator, Clinica Zabala
ClinicalTrials.gov Identifier: NCT04414098    
Other Study ID Numbers: CZabala
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Marcelo Iastrebner, Clinica Zabala:
Ruxolitinib
Covid-19
SARS