Skip to main content
OpenTrials
Completed

NCT Number: NCT04334044

Treatment of SARS Caused by COVID-19 With Ruxolitinib

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Coronavirus 2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Grupo Cooperativo de Hemopatías Malignas

Huixquilucan, State of Mexico, 52763, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ruxolitinib Oral Tablet

Drug

Ruxolitinib 5 mg twice a day

Primary outcomes

  1. Recovery of Pneumonia

    Time frame: 14 days

    Presence of recovery of pneumonia characterized by cease of respiratory symptoms

Secondary outcomes

  1. Response of C-reactive protein

    Time frame: 14 days

    Increment or decrease in mg/ml of C-reactive protein

  2. Response of Ferritin

    Time frame: 14 days

    Increment or decrease in ng/ml of ferritin

  3. Response of D-dimer

    Time frame: 14 days

    Increment or decrease in mg/ml of D-dimer

  4. Rate of ICU admission

    Time frame: 14 days

    Requirement of Intensive Care Unit on the patients under treatment

  5. Rate of mechanical ventilation

    Time frame: 14 days

    Requirement of mechanical ventilation on the patients under treatment

  6. Overall Survival

    Time frame: 1 month

    Time since the diagnosis to the last follow up (recovery or death)

  7. Toxicity Rate

    Time frame: 1 month

    Rate of adverse events associated with ruxolitinib

Sponsors and collaborators

Lead sponsor

Grupo Cooperativo de Hemopatías Malignas

Other

Registry information

Official study title

Treatment of Severe Acute Respiratory Syndrome Caused by COVID-19 With Ruxolitinib

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 3, 2020
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.