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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib | Experimental | Ruxolitinib 5 mg BID since the beginning of dyspnea or increment of work of breathing with pneumonia changes in chest CT-scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib Oral Tablet | Drug | Ruxolitinib 5 mg twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of Pneumonia | Presence of recovery of pneumonia characterized by cease of respiratory symptoms | 14 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grupo Cooperativo de HemopatÃas Malignas | Huixquilucan | State of Mexico | 52763 | Mexico |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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Use of ruxolitinib on patients with respiratory distress and pneumonia changes on chest computed tomography
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| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |