Ruxolitinib Treatment in Patients with Severe COVID-19 Infection. A Danish Safety and Efficacy Study.

Ruxolitinib Treatment in Patients with Severe COVID-19 Infection. A Danish Safety and Efficacy Study. - Ruxolitinib Treatment in Patients with Severe COVID-19 Infection.A Danish Safety and Efficacy Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001459-42-DK

Enrollment

Registered

2020-04-14

Start date

2020-04-22

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pneumonia Severly afflicted COVID-19 infected patients in respirator or in the time window with urgent need of respirator before intubation MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862

Interventions

Trade Name: Ruxolitinib (JAKAVI) Pharmaceutical Form: Tablet INN or Proposed INN: ruxolitinib (phosphate) CAS Number: 1092939-17-7 Current Sponsor code: INCB018424 phosphate Other descriptive name: RU

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years AND 2. A confirmed diagnosis of COVID-19 infection 3. Severely afflicted but still being observed in the critical time window before urgent need of respirator 4. Severely afflicted to an extent that the patient is in respirator Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. Patients of childbearing potential without a negative pregnancy test prior to initiation of study drug.

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy of therapy with ruxolitinib (Jakavi®) in patients with severe COVID-19 infection in respirator;Secondary Objective: 1. Safety of therapy with ruxolitinib in patients severely afflicted by the COVID-19 infection 2. Efficacy of therapy with ruxolitinib in patients with the COVID-19 infections in terms of a reduction in the number of patients who need respirator support by starting treatment before the patient is deemed to urgent need for respirator support 3. To demonstrate that ruxolitinib treatment is associated with a rapid decline in inflammatory cytokines, and improvement in aberrant numbers of circulating immune cells (dendritic cells, T-cells, NK-cells, B cells) and their functionality 4. To describe the genomic (as assessed by whole blood gene expression profiling and miRNA) and proteomic changes in COVID-19 infected patients during treatment with ruxolitinib. 5. To describe the microbiome before and during treatment with ruxolitinib. ;Primary end point(s): 30-days mortality;Timepoint(s) of evaluation of this end point: 30 days	—

Measure

Time frame

Main Objective: Efficacy of therapy with ruxolitinib (Jakavi®) in patients with severe COVID-19 infection in respirator;Secondary Objective: 1. Safety of therapy with ruxolitinib in patients severely afflicted by the COVID-19 infection 2. Efficacy of therapy with ruxolitinib in patients with the COVID-19 infections in terms of a reduction in the number of patients who need respirator support by starting treatment before the patient is deemed to urgent need for respirator support 3. To demonstrate that ruxolitinib treatment is associated with a rapid decline in inflammatory cytokines, and improvement in aberrant numbers of circulating immune cells (dendritic cells, T-cells, NK-cells, B cells) and their functionality 4. To describe the genomic (as assessed by whole blood gene expression profiling and miRNA) and proteomic changes in COVID-19 infected patients during treatment with ruxolitinib. 5. To describe the microbiome before and during treatment with ruxolitinib. ;Primary end point(s): 30-days mortality;Timepoint(s) of evaluation of this end point: 30 days

—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None	—

Countries

Denmark

Contacts

Public ContactHans Hasselbalch

Zealand University Hospital

hans.hasselbalch@gmail.com4526223678

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026