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Treatment of SARS Caused by COVID-19 With Ruxolitinib

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334044
Recruitment Status : Completed
First Posted : April 3, 2020
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Grupo Cooperativo de Hemopatías Malignas

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
COVID-19 Severe Acute Respiratory Syndrome Coronavirus 2 Drug: Ruxolitinib Oral Tablet Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Use of ruxolitinib on patients with respiratory distress and pneumonia changes on chest computed tomography
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Severe Acute Respiratory Syndrome Caused by COVID-19 With Ruxolitinib
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : April 12, 2021
Actual Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Recovery of Pneumonia [ Time Frame: 14 days ]
    Presence of recovery of pneumonia characterized by cease of respiratory symptoms


Secondary Outcome Measures :
  1. Response of C-reactive protein [ Time Frame: 14 days ]
    Increment or decrease in mg/ml of C-reactive protein

  2. Response of Ferritin [ Time Frame: 14 days ]
    Increment or decrease in ng/ml of ferritin

  3. Response of D-dimer [ Time Frame: 14 days ]
    Increment or decrease in mg/ml of D-dimer

  4. Rate of ICU admission [ Time Frame: 14 days ]
    Requirement of Intensive Care Unit on the patients under treatment

  5. Rate of mechanical ventilation [ Time Frame: 14 days ]
    Requirement of mechanical ventilation on the patients under treatment

  6. Overall Survival [ Time Frame: 1 month ]
    Time since the diagnosis to the last follow up (recovery or death)

  7. Toxicity Rate [ Time Frame: 1 month ]
    Rate of adverse events associated with ruxolitinib


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT04334044


Locations
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Mexico
Grupo Cooperativo de Hemopatías Malignas
Huixquilucan, Estado De México, Mexico, 52763
Sponsors and Collaborators
Grupo Cooperativo de Hemopatías Malignas
More Information
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Responsible Party: Grupo Cooperativo de Hemopatías Malignas
ClinicalTrials.gov Identifier: NCT04334044    
Other Study ID Numbers: HAL 345/2020
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Pneumonia, Viral
 Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases