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Treatment of SARS Caused by COVID-19 With Ruxolitinib

Primary Purpose

COVID-19, Severe Acute Respiratory Syndrome Coronavirus 2

Status
Completed
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Ruxolitinib Oral Tablet
Sponsored by
Grupo Cooperativo de Hemopatías Malignas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grupo Cooperativo de Hemopatías Malignas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ruxolitinib

Arm Description

Ruxolitinib 5 mg BID since the beginning of dyspnea or increment of work of breathing with pneumonia changes in chest CT-scan

Outcomes

Primary Outcome Measures

Recovery of Pneumonia
Presence of recovery of pneumonia characterized by cease of respiratory symptoms

Secondary Outcome Measures

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

Full Information

First Posted
April 1, 2020
Last Updated
July 5, 2021
Sponsor
Grupo Cooperativo de Hemopatías Malignas
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1. Study Identification

Unique Protocol Identification Number
NCT04334044
Brief Title
Treatment of SARS Caused by COVID-19 With Ruxolitinib
Official Title
Treatment of Severe Acute Respiratory Syndrome Caused by COVID-19 With Ruxolitinib
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
April 12, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grupo Cooperativo de Hemopatías Malignas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Severe Acute Respiratory Syndrome Coronavirus 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Use of ruxolitinib on patients with respiratory distress and pneumonia changes on chest computed tomography
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ruxolitinib
Arm Type
Experimental
Arm Description
Ruxolitinib 5 mg BID since the beginning of dyspnea or increment of work of breathing with pneumonia changes in chest CT-scan
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib Oral Tablet
Intervention Description
Ruxolitinib 5 mg twice a day
Primary Outcome Measure Information:
Title
Recovery of Pneumonia
Description
Presence of recovery of pneumonia characterized by cease of respiratory symptoms
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Response of C-reactive protein
Description
Increment or decrease in mg/ml of C-reactive protein
Time Frame
14 days
Title
Response of Ferritin
Description
Increment or decrease in ng/ml of ferritin
Time Frame
14 days
Title
Response of D-dimer
Description
Increment or decrease in mg/ml of D-dimer
Time Frame
14 days
Title
Rate of ICU admission
Description
Requirement of Intensive Care Unit on the patients under treatment
Time Frame
14 days
Title
Rate of mechanical ventilation
Description
Requirement of mechanical ventilation on the patients under treatment
Time Frame
14 days
Title
Overall Survival
Description
Time since the diagnosis to the last follow up (recovery or death)
Time Frame
1 month
Title
Toxicity Rate
Description
Rate of adverse events associated with ruxolitinib
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Grupo Cooperativo de Hemopatías Malignas
City
Huixquilucan
State/Province
Estado De México
ZIP/Postal Code
52763
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of SARS Caused by COVID-19 With Ruxolitinib

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