Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation

NCT04338958 | Completed Phase 2

• 1 other identifier: RuxCoFlam
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 6

Brief Summary

RuxCoFlam is a single arm, non-randomized open phase II trial for front line treatment of Covid-19 patients with defined hyperinflammation.

Conditions

Covid-19

Outcome Measures

Primary Outcomes (1)

• overall response rate in reversal of hyperinflammation

  Patients achieving 25% reduction in hyperinflammation score (CIS) compared to baseline at day 7

  day 7 after start of therapy

Study Arms (1)

Ruxolitinib

EXPERIMENTAL

2 x 10mg Ruxolitinib with defined response adapted dose escalation up to 2 x 20mg for a duration of 7 days

Drug: Ruxolitinib

Interventions

Ruxolitinib DRUG

2 x 10mg Ruxolitinib with defined response adapted dose escalation up to 2 x 20mg for a duration of 7 days with clinical and/or radiographic response assessment

Ruxolitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patient or guardian must provide written informed consent (and assent if applicable) before any study assessment is performed.
• \. Male and female patients aged ≥ 18 years.
• \. Patients with temperature \> 37.3°C
• \. Patients with respiratory symptoms and/or hypoxia SpO2 \< 93%
• \. Patients with Covid-19 stage II and stage III
• \. Patients with lung imaging showing bi-pulmonary infiltrates (chest X-ray or CT scan).
• \. Patients, with a Covid Inflammation Score ≥ 10

You may not qualify if:

• \. History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.
• \. Uncontrolled active bacterial, fungal, viral, or other infection (besides COVID-19).
• \. Active Tuberculosis infection.
• \. Known Positivity for HBV, HCV or HIV.
• \. Patients who are on long-term use of oral anti-rejection or immunomodulatory drugs
• \. Participating in any other interventional clinical trial for COVID-19.
• \. Treatment with cytokine-directed agents such as anti-IL6 or anti-IL1R directed antibodies (i.e. tocilizumab, anakinra). Other treatment modalities used in locally adapted SOPs (corticosteroids, chloroquine, hydroxychloroquine, lopinavir-ritonavir) may be given with daily documentation of dose and schedule.
• \. ALT or AST \> 5 x ULN detected within 24 hours at screening (according to local laboratory reference ranges).
• \. ANC \< 500/µL at screening (according to local laboratory reference ranges).
• \. Platelet count \< 50,000/µL at screening (according to local laboratory reference ranges).
• \. Hemoglobin \< 6 g/dl (3.73mmol/l)
• \. Pregnant or nursing (lactating) women.
• \. Female patients of childbearing potential (e.g. are menstruating) and male patients who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception as defined below, throughout the study and for up to 90 days after stopping treatment, OR Female patients of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception as defined below, throughout the study and for up to 90 days after stopping treatment.
• Highly effective contraception methods include:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

Sponsors & Collaborators

• University of Jena: lead

Study Sites (6)

SRH Wald-Klinikum Gera GmbH

Gera, 07548, Germany

Location

University Hospital Jena

Jena, 07747, Germany

Location

UKSH, Campus Lübeck

Lübeck, 23538, Germany

Location

Klinikum der Landeshauptstadt Stuttgart gKöR

Stuttgart, 70174, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

Villingen-Schwenningen, 78052, Germany

Location

Related Publications (2)

• Hammersen J, Birndt S, Dohner K, Reuken P, Stallmach A, Sauerbrey P, La Rosee F, Pfirrmann M, Fabisch C, Weiss M, Trager K, Bremer H, Russo S, Illerhaus G, Dromann D, Schneider S, La Rosee P, Hochhaus A. The JAK1/2 inhibitor ruxolitinib in patients with COVID-19 triggered hyperinflammation: the RuxCoFlam trial. Leukemia. 2023 Sep;37(9):1879-1886. doi: 10.1038/s41375-023-01979-w. Epub 2023 Jul 28.

  PMID: 37507425 DERIVED

• La Rosee F, Bremer HC, Gehrke I, Kehr A, Hochhaus A, Birndt S, Fellhauer M, Henkes M, Kumle B, Russo SG, La Rosee P. The Janus kinase 1/2 inhibitor ruxolitinib in COVID-19 with severe systemic hyperinflammation. Leukemia. 2020 Jul;34(7):1805-1815. doi: 10.1038/s41375-020-0891-0. Epub 2020 Jun 9.

  PMID: 32518419 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Andreas Hochhaus, Prof. Dr.

  University Hospital Jena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single arm, non-randomized

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 8, 2020
• Study Start: April 22, 2020
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: August 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)