ARDS, HumanPhase 2RuXoCoilNCT04359290

Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS

A Phase 2 study testing Ruxolitinib administration in people with ARDS, Human and COVID, run by Philipps University Marburg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: ARDS, Human, COVID
What is being tested?: Ruxolitinib administration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteGermany
Study dates: 1 Jul 2020to 30 Jul 2021
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
Recent intubation
Requirement of invasive ventilation moderate to severe pulmonary oxygen exchange disturbance as defined by (PaO2/FiO2) ≤ 200 mmHg at a PEEP ≥ 5mm H2O

Show all 10Show fewer

Serum LDH > 283 U/l
Ferritin above normal value
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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Andreas Neubauer
Marburg, D-35043

Other trials in Germany

About this study

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

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

Read the 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.

Conditions: ARDS, Human, COVID
Being tested: Ruxolitinib administration
Keywords: Covid-19, ARDS, Ruxolitinib, Janus kinase, JAK1, JAK2
Medical subject headings: Respiratory Distress Syndrome, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ruxolitinib administrationDrug
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.

Study groups in NCT04359290
Study group	Role	What they receive
Ruxolitinib treatment	Experimental	Ruxolitinib will be administered p.o. or by gavage feeding for max 28 days Receives: Drug: Ruxolitinib administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall survival
To determine the efficacy of ruxolitinib measured by overall survival
Measured: 28 days after registration into trial

Secondary outcomes (11)

Assessment of the duration of ventilation support
Assessment of the duration of ventilation support
Measured: registration until 90 days after registration into trial
cytokine storm
Assessment of the extent of cytokine storm reduction (IL-6, CRP, ferritin)
Measured: registration until 90 days after registration into trial
time on ICU
To assess time on ICU
Measured: registration until 90 days after registration into trial
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
Measured: registration until 90 days after registration into trial
time frame for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG)
To assess the timeframe for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG)
Measured: registration until 90 days after registration into trial
Rates of flow
To asses the rates of flow (liter/minute), in order to detect possible amelioration of pulmonary function after Covid-19 infection
Measured: Discharge from hospital (end of treatment)
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
Measured: Discharge from hospital (end of treatment)
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
Measured: Discharge from hospital (end of treatment)
Forced vital capacity (FVC)
To assess forced vital capacity (liters), in order to detect possible possible amelioration of pulmonary function after Covid-19 infection
Measured: Discharge from hospital (end of treatment)
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
Measured: Discharge from hospital (end of treatment)
Overall survival
To determine the efficacy of ruxolitinib measured by overall survival
Measured: 90 days after registration into trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202030 Jul 2021

First posted24 Apr 2020
Study start1 Jul 2020
Primary completion31 Dec 2020
Study completion30 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for ARDS, HumanStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04359290
Sponsor's protocol ID: KKS-278
Acronym: RuXoCoil
Status last verified: Nov 2020
First submitted: 15 Apr 2020
Last updated: 24 Aug 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Study protocol will be provided after publication

Publications

Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
PubMed 32064853
Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
PubMed 32105632
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076
Xia W, Shao J, Guo Y, Peng X, Li Z, Hu D. Clinical and CT features in pediatric patients with COVID-19 infection: Different points from adults. Pediatr Pulmonol. 2020 May;55(5):1169-1174. doi: 10.1002/ppul.24718. Epub 2020 Mar 5.
PubMed 32134205
Wei M, Yuan J, Liu Y, Fu T, Yu X, Zhang ZJ. Novel Coronavirus Infection in Hospitalized Infants Under 1 Year of Age in China. JAMA. 2020 Apr 7;323(13):1313-1314. doi: 10.1001/jama.2020.2131.
PubMed 32058570
[WHO] World Health Organization. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected [Resource on the internet]. 2020 [updated 13 March 2020; cited 24 March 2020]. Available from: https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-suspected
An Insight of comparison between COVID-19 (2019-nCoV disease) and SARS in pathology and pathogenesis. Author: Xiaolong Cai; Internet posting, of 27-Feb-2020 retrieved 24-Mar-2020. Cite as DOI: 10.31219/osf.io/hw34x
Hermans MAW, Schrijver B, van Holten-Neelen CCPA, Gerth van Wijk R, van Hagen PM, van Daele PLA, Dik WA. The JAK1/JAK2- inhibitor ruxolitinib inhibits mast cell degranulation and cytokine release. Clin Exp Allergy. 2018 Nov;48(11):1412-1420. doi: 10.1111/cea.13217. Epub 2018 Aug 3.
PubMed 29939445
Zhao J, Yu H, Liu Y, Gibson SA, Yan Z, Xu X, Gaggar A, Li PK, Li C, Wei S, Benveniste EN, Qin H. Protective effect of suppressing STAT3 activity in LPS-induced acute lung injury. Am J Physiol Lung Cell Mol Physiol. 2016 Nov 1;311(5):L868-L880. doi: 10.1152/ajplung.00281.2016. Epub 2016 Sep 16.
PubMed 27638904
Coon TA, McKelvey AC, Lear T, Rajbhandari S, Dunn SR, Connelly W, Zhao JY, Han S, Liu Y, Weathington NM, McVerry BJ, Zhang Y, Chen BB. The proinflammatory role of HECTD2 in innate immunity and experimental lung injury. Sci Transl Med. 2015 Jul 8;7(295):295ra109. doi: 10.1126/scitranslmed.aab3881.
PubMed 26157031
Ruxolitinib Prevents Cytokine Release Syndrome after CART Cell Therapy without Impairing the Anti-Tumor Effect in a Xenograft Model Saad S Kenderian, MD , Blood (2016) 128 (22): 652
Calbet M, Ramis I, Calama E, Carreno C, Paris S, Maldonado M, Orellana A, Calaf E, Pauta M, De Alba J, Bach J, Miralpeix M. Novel Inhaled Pan-JAK Inhibitor, LAS194046, Reduces Allergen-Induced Airway Inflammation, Late Asthmatic Response, and pSTAT Activation in Brown Norway Rats. J Pharmacol Exp Ther. 2019 Aug;370(2):137-147. doi: 10.1124/jpet.119.256263. Epub 2019 May 13.
PubMed 31085698
The definition and risks of Cytokine Release Syndrome-Like in 11 COVID-19-Infected Pneumonia critically ill patients: Disease Characteristics and Retrospective Analysis Wenjun Wang Jr. et al Internet posting of 27-Feb-2020 retrieved 24-Mar-2020 Cite as: https://doi.org/10.1101/2020.02.26.20026989
Hoffmann J, Machado D, Terrier O, Pouzol S, Messaoudi M, Basualdo W, Espinola EE, Guillen RM, Rosa-Calatrava M, Picot V, Benet T, Endtz H, Russomando G, Paranhos-Baccala G. Viral and bacterial co-infection in severe pneumonia triggers innate immune responses and specifically enhances IP-10: a translational study. Sci Rep. 2016 Dec 6;6:38532. doi: 10.1038/srep38532.
PubMed 27922126

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All ARDS, Human trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ruxolitinib for Treatment of Covid-19 Induced Lung Injury ARDS A Single-arm, Open-label, Proof of Concept Study
ClinicalTrials.gov ID: NCT04359290
Acronym / sponsor ID: RuXoCoil / KKS-278
Conditions: ARDS, Human, COVID
Keywords: Covid-19, ARDS, Ruxolitinib, Janus kinase, JAK1, JAK2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Philipps University MarburgUniversity, hospital or other
Study start: 1 Jul 2020 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 30 Jul 2021 (actual)
First posted: 24 Apr 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Ruxolitinib treatment	Experimental	Drug: Ruxolitinib administrationRuxolitinib will be administered p.o. or by gavage feeding for max 28 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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:
Patient or patient´s representative must provide written informed consent (and assent if applicable) before any study assessment is performed.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ruxolitinib administrationRuxolitinib 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.	Drug	Ruxolitinib treatment

Primary outcome

Overall survival
Time frame: 28 days after registration into trial
To determine the efficacy of ruxolitinib measured by overall survival

11 secondary outcomes

Assessment of the duration of ventilation support
Time frame: registration until 90 days after registration into trial
cytokine storm
Time frame: registration until 90 days after registration into trial
time on ICU
Time frame: registration until 90 days after registration into trial
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: registration until 90 days after registration into trial
time frame for seroconversion under ruxolitinib treatment (SARS-Co-19- IgG)
Time frame: registration until 90 days after registration into trial
Rates of flow
Time frame: Discharge from hospital (end of treatment)
Gas exchange
Time frame: Discharge from hospital (end of treatment)
Forced expiratory volume in 1 second (FEV1)
Time frame: Discharge from hospital (end of treatment)
Forced vital capacity (FVC)
Time frame: Discharge from hospital (end of treatment)
Tiffeneau-Pinelli index
Time frame: Discharge from hospital (end of treatment)
Overall survival
Time frame: 90 days after registration into trial

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
Background: PubMed 32064853Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
Background: PubMed 32105632Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
Background: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
Background: PubMed 32134205Xia W, Shao J, Guo Y, Peng X, Li Z, Hu D. Clinical and CT features in pediatric patients with COVID-19 infection: Different points from adults. Pediatr Pulmonol. 2020 May;55(5):1169-1174. doi: 10.1002/ppul.24718. Epub 2020 Mar 5.
Background: PubMed 32058570Wei M, Yuan J, Liu Y, Fu T, Yu X, Zhang ZJ. Novel Coronavirus Infection in Hospitalized Infants Under 1 Year of Age in China. JAMA. 2020 Apr 7;323(13):1313-1314. doi: 10.1001/jama.2020.2131.
Background[WHO] World Health Organization. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected [Resource on the internet]. 2020 [updated 13 March 2020; cited 24 March 2020]. Available from: https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-suspected
BackgroundAn Insight of comparison between COVID-19 (2019-nCoV disease) and SARS in pathology and pathogenesis. Author: Xiaolong Cai; Internet posting, of 27-Feb-2020 retrieved 24-Mar-2020. Cite as DOI: 10.31219/osf.io/hw34x
Background: PubMed 29939445Hermans MAW, Schrijver B, van Holten-Neelen CCPA, Gerth van Wijk R, van Hagen PM, van Daele PLA, Dik WA. The JAK1/JAK2- inhibitor ruxolitinib inhibits mast cell degranulation and cytokine release. Clin Exp Allergy. 2018 Nov;48(11):1412-1420. doi: 10.1111/cea.13217. Epub 2018 Aug 3.
Background: PubMed 27638904Zhao J, Yu H, Liu Y, Gibson SA, Yan Z, Xu X, Gaggar A, Li PK, Li C, Wei S, Benveniste EN, Qin H. Protective effect of suppressing STAT3 activity in LPS-induced acute lung injury. Am J Physiol Lung Cell Mol Physiol. 2016 Nov 1;311(5):L868-L880. doi: 10.1152/ajplung.00281.2016. Epub 2016 Sep 16.
Background: PubMed 26157031Coon TA, McKelvey AC, Lear T, Rajbhandari S, Dunn SR, Connelly W, Zhao JY, Han S, Liu Y, Weathington NM, McVerry BJ, Zhang Y, Chen BB. The proinflammatory role of HECTD2 in innate immunity and experimental lung injury. Sci Transl Med. 2015 Jul 8;7(295):295ra109. doi: 10.1126/scitranslmed.aab3881.
BackgroundRuxolitinib Prevents Cytokine Release Syndrome after CART Cell Therapy without Impairing the Anti-Tumor Effect in a Xenograft Model Saad S Kenderian, MD , Blood (2016) 128 (22): 652
Individual participant dataSharing planned: Yes. Study protocol will be provided after publication

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andreas Neubauer, Prof Dr. principal investigator

Universitätsklinikum Giessen und Marburg (UKGM)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ruxolitinib administration in people with ARDS, Human and COVID, run by Philipps University Marburg at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 28 days after registration into trial). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04359290, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.