Treatment of SARS Caused by COVID-19 With Ruxolitinib

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19, Severe Acute Respiratory Syndrome Coronavirus 2

Intervention / Treatment
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* Drug: Ruxolitinib Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Use of ruxolitinib on patients with respiratory distress and pneumonia changes on chest computed tomography
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ruxolitinib<br>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<br>* Ruxolitinib 5 mg twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

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