Treatment of SARS Caused by COVID-19 With Ruxolitinib

NCT ID: NCT04334044

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-04-30

Brief Summary

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.

Conditions

COVID-19; Severe Acute Respiratory Syndrome Coronavirus 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ruxolitinib

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

Group Type: EXPERIMENTAL

Ruxolitinib Oral Tablet

Intervention Type: DRUG

Ruxolitinib 5 mg twice a day

Interventions

Ruxolitinib Oral Tablet

Ruxolitinib 5 mg twice a day

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Cooperativo de Hemopatías Malignas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Grupo Cooperativo de Hemopatías Malignas

Huixquilucan, State of Mexico, Mexico

Countries

Mexico

Other Identifiers

HAL 345/2020

Identifier Type: -

Identifier Source: org_study_id