Treatment of SARS Caused by COVID-19 With Ruxolitinib

Sponsor
Grupo Cooperativo de Hemopatías Malignas
Study ID
NCT04334044
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • COVID-19
  • Severe Acute Respiratory Syndrome Coronavirus 2

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 1, 2020
Status verified
Jul 2021
Primary completion
Apr 12, 2021
Completion
Apr 30, 2021

Study Design

Enrollment
77 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Recovery of Pneumonia [ Time Frame: 14 days ]

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