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Treatment of SARS Caused by COVID-19 With Ruxolitinib

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ClinicalTrials.gov Identifier: NCT04334044
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Grupo Cooperativo de Hemopatías Malignas

Tracking Information
First Submitted Date  ICMJE April 1, 2020
First Posted Date  ICMJE April 3, 2020
Last Update Posted Date February 2, 2021
Actual Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
Recovery of Pneumonia [ Time Frame: 14 days ]
Presence of recovery of pneumonia characterized by cease of respiratory symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
  • Response of C-reactive protein [ Time Frame: 14 days ]
    Increment or decrease in mg/ml of C-reactive protein
  • Response of Ferritin [ Time Frame: 14 days ]
    Increment or decrease in ng/ml of ferritin
  • Response of D-dimer [ Time Frame: 14 days ]
    Increment or decrease in mg/ml of D-dimer
  • Rate of ICU admission [ Time Frame: 14 days ]
    Requirement of Intensive Care Unit on the patients under treatment
  • Rate of mechanical ventilation [ Time Frame: 14 days ]
    Requirement of mechanical ventilation on the patients under treatment
  • Overall Survival [ Time Frame: 1 month ]
    Time since the diagnosis to the last follow up (recovery or death)
  • Toxicity Rate [ Time Frame: 1 month ]
    Rate of adverse events associated with ruxolitinib
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of SARS Caused by COVID-19 With Ruxolitinib
Official Title  ICMJE Treatment of Severe Acute Respiratory Syndrome Caused by COVID-19 With Ruxolitinib
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • COVID-19
  • Severe Acute Respiratory Syndrome Coronavirus 2
Intervention  ICMJE Drug: Ruxolitinib Oral Tablet
Ruxolitinib 5 mg twice a day
Study Arms  ICMJE Experimental: Ruxolitinib
Ruxolitinib 5 mg BID since the beginning of dyspnea or increment of work of breathing with pneumonia changes in chest CT-scan
Intervention: Drug: Ruxolitinib Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04334044
Other Study ID Numbers  ICMJE HAL 345/2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Grupo Cooperativo de Hemopatías Malignas
Study Sponsor  ICMJE Grupo Cooperativo de Hemopatías Malignas
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Grupo Cooperativo de Hemopatías Malignas
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP