Treatment of SARS Caused by COVID-19 With Ruxolitinib

NCT04334044 | Completed Phase 1 DMC

• 1 other identifier: HAL 345/2020
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Recovery of Pneumonia

  Presence of recovery of pneumonia characterized by cease of respiratory symptoms

  14 days

Secondary Outcomes (7)

• Response of C-reactive protein

  14 days

• Response of Ferritin

  14 days

• Response of D-dimer

  14 days

• Rate of ICU admission

  14 days

• Rate of mechanical ventilation

  14 days

Study Arms (1)

Ruxolitinib

EXPERIMENTAL

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

Interventions

Ruxolitinib Oral Tablet DRUG

Ruxolitinib 5 mg twice a day

Ruxolitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Cooperativo de Hemopatías Malignas: lead

Study Sites (1)

Grupo Cooperativo de Hemopatías Malignas

Huixquilucan, State of Mexico, 52763, Mexico

Location

MeSH Terms

Conditions

COVID-19

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Use of ruxolitinib on patients with respiratory distress and pneumonia changes on chest computed tomography

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: September 1, 2020
• Primary Completion: April 12, 2021
• Study Completion: April 30, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)