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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: Completed
Phase of Trial: Phase I/II

Latest Information Update: 04 Nov 2021

At a glance

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

    • 05 Jul 2021 Status changed from recruiting to completed.
    • 01 Feb 2021 Planned End Date changed from 1 Jun 2020 to 1 May 2021.
    • 01 Feb 2021 Planned primary completion date changed from 1 Jun 2020 to 1 Mar 2021.

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 -

Biomarker

NCT Number Biomarker Name Biomarker Function
NCT04334044 C-reactive protein (CRP) Outcome Measure
D-dimer Outcome Measure
Ferritin Outcome Measure
seryl-tRNA synthetase Brief Title
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Subjects

  • Subject Type patients
  • Number

    Planned: 20

    Actual: 77

  • 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 : 01 Sep 2020

  • Primary Completion Dates

    Planned : 01 Mar 2021

    Actual : 12 Apr 2021

  • End Dates

    Planned : 01 May 2021

    Actual : 30 Apr 2021

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
08 Jul 2021 Other trial event Last checked against ClinicalTrials.gov record. Updated 08 Jul 2021
07 Jul 2021 Biomarker Update Biomarkers information updated Updated 04 Nov 2021
05 Jul 2021 Status change - completed Status changed from recruiting to completed. Updated 08 Jul 2021
01 Feb 2021 Completion date Planned End Date changed from 1 Jun 2020 to 1 May 2021. Updated 05 Feb 2021
01 Feb 2021 Other trial event Planned primary completion date changed from 1 Jun 2020 to 1 Mar 2021. Updated 05 Feb 2021
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 2023;.

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