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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 20 Apr 2020

At a glance

  • Drugs Ruxolitinib (Primary)
  • Indications COVID 2019 infections; Severe acute respiratory syndrome
  • Focus Therapeutic Use
  • Most Recent Events

    • 16 Apr 2020 Status changed from not yet recruiting to recruiting.
    • 07 Apr 2020 New trial record

Trial Overview

Purpose

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.

Primary Endpoints

Recovery of Pneumonia

description: Presence of recovery of pneumonia characterized by cease of respiratory symptoms
time_frame: 14 days

Other Endpoints

Response of C-reactive protein

description: Increment or decrease in mg/ml of C-reactive protein
time_frame: 14 days

Response of Ferritin

description: Increment or decrease in ng/ml of ferritin
time_frame: 14 days

Response of D-dimer

description: Increment or decrease in mg/ml of D-dimer
time_frame: 14 days

Rate of ICU admission

description: Requirement of Intensive Care Unit on the patients under treatment
time_frame: 14 days

Rate of mechanical ventilation

description: Requirement of mechanical ventilation on the patients under treatment
time_frame: 14 days

Overall Survival

description: Time since the diagnosis to the last follow up (recovery or death)
time_frame: 1 month

Toxicity Rate

description: Rate of adverse events associated with ruxolitinib
time_frame: 1 month [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Severe acute respiratory syndrome treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 20

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient 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

Patient 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 Details

Identifiers

Identifier Owner
NCT04334044 ClinicalTrials.gov: US National Institutes of Health
HAL345-2020 -

Trial Dates

  • Initiation Dates

    Planned : 01 Apr 2020

    Actual : 15 Apr 2020

  • Primary Completion Dates

    Planned : 01 Jun 2020

  • End Dates

    Planned : 01 Jun 2020

Other Details

  • Design open; prospective
  • Phase of Trial Phase I/II
  • Location Mexico
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
RuxolitinibPrimary Drug Oral Tablet

Ruxolitinib

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 (Ruxolitinib 5 mg twice a day)

Trial Centres

Centres

Centre Name Location Trial Centre Country
Grupo Cooperativo de Hemopatías Malignas
-
-
Grupo Cooperativo de Hemopatías Malignas Huixquilucan, Estado De México Mexico

Trial History

Event Date Event Type Comment
20 Apr 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 20 Apr 2020
16 Apr 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 20 Apr 2020
07 Apr 2020 New trial record New trial record Updated 07 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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