Treatment of SARS Caused by COVID-19 With Ruxolitinib

Grupo Cooperativo de Hemopatías Malignas

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19; Severe Acute Respiratory Syndrome Coronavirus 2

Treatments: Drug: Ruxolitinib Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04334044

HAL 345/2020

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

Ruxolitinib

Experimental group

Description:

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

Treatment:

Drug: Ruxolitinib Oral Tablet