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Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS (RuXoCoil)

Primary Purpose

ARDS, Human, COVID

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Ruxolitinib administration

About this trial

This is an interventional treatment trial for ARDS, Human focused on measuring Covid-19, ARDS, Ruxolitinib, Janus kinase, JAK1, JAK2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or non-pregnant female adult ≥18 years of age at time of enrollment.
has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay (result of the PCR is not necessary for inclusion, but has to approved latest within 48-72 hours after registration)
Willingness of men and women of childbearing potential to use highly effective contraceptive methods by abstinence or by using at least two contraceptive methods from the date of consent to the end of the study
severe lung disease as defined by following:
1. Recent intubation
2. Requirement of invasive ventilation moderate to severe pulmonary oxygen exchange disturbance as defined by (PaO2/FiO2) ≤ 200 mmHg at a PEEP ≥ 5mm H2O
3. Serum LDH > 283 U/l
4. Ferritin above normal value
5. CT-scan: pulmonary infiltration compatible with Covid-19 disease
Patient or patient´s representative must provide written informed consent (and assent if applicable) before any study assessment is performed.

Exclusion Criteria:

Uncontrolled HIV infection
Active tuberculosis (result of positive tuberculosis infection is not necessary for exclusion, but has to approved later on during patient´s intervention)
Chronic kidney disease requiring dialysis
ALT/AST > 5 times the upper limit of normal.
Pregnancy or breast feeding.
Allergy to study medication
Simultaneous participation in another clinical trial with an experimental treatment

Sites / Locations

Andreas Neubauer

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ruxolitinib treatment

Arm Description

Ruxolitinib will be administered p.o. or by gavage feeding for max 28 days

Outcomes

Primary Outcome Measures

Overall survival

To determine the efficacy of ruxolitinib measured by overall survival

Secondary Outcome Measures

Assessment of the duration of ventilation support

cytokine storm

Assessment of the extent of cytokine storm reduction (IL-6, CRP, ferritin)

time on ICU

To assess time on ICU

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

In order to classify the severity of the AEs, number of participants with treatment-related adverse events will be assessed by the "Common Terminology Criteria for Adverse Events" (CTCAE) version 5.0

time frame for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG)

To assess the timeframe for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG)

Rates of flow

To asses the rates of flow (liter/minute), in order to detect possible amelioration of pulmonary function after Covid-19 infection

Gas exchange

To asses gas exchange (partial pressure of oxygen and carbon dioxide), in order to detect possible amelioration of pulmonary function after Covid-19 infection

Forced expiratory volume in 1 second (FEV1)

To assess forced expiratory volume in 1 second (liters), in order to detect possible possible amelioration of pulmonary function after Covid-19 infection

Forced vital capacity (FVC)

To assess forced vital capacity (liters), in order to detect possible possible amelioration of pulmonary function after Covid-19 infection

Tiffeneau-Pinelli index

To assess Tiffeneau-Pinelli index (FEV1/FVC ratio in %), in order to detect possible possible amelioration of pulmonary function after Covid-19 infection

Overall survival

To determine the efficacy of ruxolitinib measured by overall survival

Full Information

NCT ID

NCT04359290

First Posted

April 15, 2020

Last Updated

August 23, 2021

Sponsor

Philipps University Marburg Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04359290

Brief Title

Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS

Acronym

RuXoCoil

Official Title

Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS A Single-arm, Open-label, Proof of Concept Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Philipps University Marburg Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of patients with COVID-19 severe pneumonia.

Detailed Description

This clinical trial is an open-label trial of ruxolitinib for the treatment of severe COVID-19 to assess its efficacy and safety. Ruxolitinib (INCB018424 phosphate, INC424, ruxolitinib phosphate) is a well established, potent and selective inhibitor of Janus kinase (JAK)1 and JAK2, with modest to marked selectivity against tyrosine kinase (TYK)2 and JAK3, respectively. Ruxolitinib interferes with the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. Ruxolitinib (JAKAVI®) is currently approved in the European Union (EU) for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (PMF) (also known as chronic idiopathic MF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF) and for the treatment of adult patients with PV who are resistant to or intolerant of hydroxyurea (HU). In the US, ruxolitinib has been approved in the treatment of steroid refractory graft versus host disease post allogeneic stem cell transplantation. Because many patients with severe respiratory disease due to COVID-19 have features consistent with the cytokine release syndrome (CRS) and increased activation of the JAK/STAT pathway, it is postulated that ruxolitinib might have a useful role in treating these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ARDS, Human, COVID

Keywords

Covid-19, ARDS, Ruxolitinib, Janus kinase, JAK1, JAK2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Ruxolitinib will be administered p.o. or by gavage feeding starting with 2 x 10mg or 2 x 15mg bid dose at day 1 according to the investigator's decision and can be increased up to 2 x 15mg bid from day 2 to day 28 (max) (depending on platelet counts and renal function). Ruxolitinib will be administered in the morning and evening. Dosing will be adjusted according to toxicity and kidney function; open design, single arm.If the patient is discharged before day 28, the therapy will be discontinued for discharge.

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ruxolitinib treatment

Arm Type

Experimental

Arm Description

Ruxolitinib will be administered p.o. or by gavage feeding for max 28 days

Intervention Type

Drug

Intervention Name(s)

Ruxolitinib administration

Intervention Description

Ruxolitinib will be administered p.o. or by gavage feeding starting with 2 x 10mg or 2 x 15mg bid dose at day 1 according to the investigator's decision and can be increased up to 2 x 15mg bid from day 2 to day 28 (max) (depending on platelet counts and renal function). Ruxolitinib will be administered in the morning and evening. Dosing will be adjusted according to toxicity and kidney function.If the patient is discharged before day 28, the therapy will be discontinued for discharge.

Primary Outcome Measure Information:

Title

Overall survival

Description

To determine the efficacy of ruxolitinib measured by overall survival

Time Frame

28 days after registration into trial

Secondary Outcome Measure Information:

Title

Assessment of the duration of ventilation support

Description

Assessment of the duration of ventilation support

Time Frame

registration until 90 days after registration into trial

Title

cytokine storm

Description

Assessment of the extent of cytokine storm reduction (IL-6, CRP, ferritin)

Time Frame

registration until 90 days after registration into trial

Title

time on ICU

Description

To assess time on ICU

Time Frame

registration until 90 days after registration into trial

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Description

In order to classify the severity of the AEs, number of participants with treatment-related adverse events will be assessed by the "Common Terminology Criteria for Adverse Events" (CTCAE) version 5.0

Time Frame

registration until 90 days after registration into trial

Title

time frame for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG)

Description

To assess the timeframe for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG)

Time Frame

registration until 90 days after registration into trial

Title

Rates of flow

Description

To asses the rates of flow (liter/minute), in order to detect possible amelioration of pulmonary function after Covid-19 infection

Time Frame