A Phase 1/2 interventional study of Ruxolitinib Oral Tablet in COVID-19 and Severe Acute Respiratory Syndrome Coronavirus 2, sponsored by Grupo Cooperativo de Hemopatías Malignas. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by Grupo Cooperativo de Hemopatías Malignas · Phase 1/2, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 77 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Grupo Cooperativo de Hemopatías Malignas is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Recovery of Pneumonia
Presence of recovery of pneumonia characterized by cease of respiratory symptoms
Time frame: 14 days
Response of C-reactive protein
Increment or decrease in mg/ml of C-reactive protein
Time frame: 14 days
Response of Ferritin
Increment or decrease in ng/ml of ferritin
Time frame: 14 days
Response of D-dimer
Increment or decrease in mg/ml of D-dimer
Time frame: 14 days
Rate of ICU admission
Requirement of Intensive Care Unit on the patients under treatment
Time frame: 14 days
Rate of mechanical ventilation
Requirement of mechanical ventilation on the patients under treatment
Time frame: 14 days
Overall Survival
Time since the diagnosis to the last follow up (recovery or death)
Time frame: 1 month
Toxicity Rate
Rate of adverse events associated with ruxolitinib
Time frame: 1 month
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Grupo Cooperativo de Hemopatías Malignas