Ruxolitinib in the Treatment of Covid-19

June 1, 2020 updated by: Marcelo Iastrebner

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
during 14 days after the commencement of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the median duration of hospitalization.
Time Frame: after 45 days of commencement of treatment.
after 45 days of commencement of treatment.
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).
after 45 days of commencement of treatment.
Evaluate COVID-19 mortality rate
Time Frame: after 45 days of treatment.
after 45 days of treatment.
Evaluate the proportion of the requirement of mechanical ventilation.
Time Frame: with a total follow-up of 45 days
with a total follow-up of 45 days
Evaluate ruxolitinib adverse reactions
Time Frame: with a total follow-up of 45 days.
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.
after 45 days of commencement of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marcelo Iastrebner

Collaborators

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

August 15, 2020

Study Completion (Anticipated)

September 15, 2020

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZabala

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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