Treatment of SARS Caused by COVID-19 With Ruxolitinib

July 5, 2021 updated by: Grupo Cooperativo de Hemopatías Malignas

Treatment of Severe Acute Respiratory Syndrome Caused by COVID-19 With Ruxolitinib

In December 2019, a new virus emerged in Wuhan, China rapidly becoming a pandemic with registered cases above 800,000 around the world. The virus is now known as SARS-CoV2 calling its disease coronavirus-19 or COVID-19. The mortality of the virus has been reported around 2-10% and its causes because of the proinflammatory immune response generated on the host. The cytokines involved in the immune response to COVID-19 are IL-1, IL-2, IL4, IL-6, IL-10, IL-12, IL-13, IL-17, GCSF, MCSF, IP-10, MCP-1, MIP-1α, HGF, IFN-γ y TNF-α.

Ruxolitinib is an inhibitor of JAK 1/2 which is responsable for multiple cellular signals including the proinflammatory IL-6. Ruxolitinib works as and immunomodulator decreasing the cytotoxic T lymphocytes and increasing the Treg cells.

This study is intended to stop the disregulated immune response caused by COVID-19 that generates the pneumonia and subsequent severe acute respiratory syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • Mexico
    • Estado De México
      • Huixquilucan, Estado De México, Mexico, 52763
        • Grupo Cooperativo de Hemopatías Malignas

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with diagnosed COVID-19 with confirmatory test
  • Increase in work of breathing or presence of dyspnea
  • Presence of lung changes associated with COVID pneumonia by chest imaging
  • Informed consent

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Thrombocytopenia below 20,000 cells/mm3
  • Neutropenia below 500 cels/mm3
  • Known and active infection of HIV, Hepatitis C, Hepatitis B, Herpes Zoster or Mycobacterium Tuberculosis

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ruxolitinib
Ruxolitinib 5 mg BID since the beginning of dyspnea or increment of work of breathing with pneumonia changes in chest CT-scan
Drug: Ruxolitinib Oral Tablet
Ruxolitinib 5 mg twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery of Pneumonia
Time Frame: 14 days
Presence of recovery of pneumonia characterized by cease of respiratory symptoms
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response of C-reactive protein
Time Frame: 14 days
Increment or decrease in mg/ml of C-reactive protein
14 days
Response of Ferritin
Time Frame: 14 days
Increment or decrease in ng/ml of ferritin
14 days
Response of D-dimer
Time Frame: 14 days
Increment or decrease in mg/ml of D-dimer
14 days
Rate of ICU admission
Time Frame: 14 days
Requirement of Intensive Care Unit on the patients under treatment
14 days
Rate of mechanical ventilation
Time Frame: 14 days
Requirement of mechanical ventilation on the patients under treatment
14 days
Overall Survival
Time Frame: 1 month
Time since the diagnosis to the last follow up (recovery or death)
1 month
Toxicity Rate
Time Frame: 1 month
Rate of adverse events associated with ruxolitinib
1 month

Collaborators and Investigators

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

Sponsor

Grupo Cooperativo de Hemopatías Malignas

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 (Actual)

September 1, 2020

Primary Completion (Actual)

April 12, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 5, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAL 345/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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