NCT04338958

Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation

A Phase-II Clinical Trial for First Line Treatment of Stage II/III Covid-19 Patients to Treat Hyperinflammation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: University of Jena · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

RuxCoFlam is a single arm, non-randomized open phase II trial for front line treatment of Covid-19 patients with defined hyperinflammation. Purpose of the study is the reversal of hyperinflammation to improve pulmonary function, reduce respiratory dependency and reduce mortality. Patients with a hyperinflammation Score 10/16 without a clinical diagnosis of sepsis will be treated with 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. Inflammation assessment will be performed every other day (day 3, 5,7) using the CIS. In patients with unaffected CIS alteration \< 25% or increasing CIS \> 25% dose escalation by 5mg steps (15mg, day3; 20mg day 5) at the investigator´s discretion. Treatment can be extended up to 28 days if clinically indicated and the benefits of treatment outweigh the risks. Primary endpoint of the study is the overall response rate in reversal of hyperinflammation at day 7 compared to baseline. Secondary endpoints are total use of assisted oxygenation dependency (duration (days) of invasive/non-invasive ventilation or duration (days) of high-flow Oxygen support), radiologic response (reversal of pulmonary Covid-signs, Lung-XRay/CT), day 15 clinical status and day 15 and day 29 mortality. Patients aged ≥18 years hospitalized with COVID-19 pneumonia (demonstrated by CXRAY or chest CT), with a study specific Covid Inflammation Score ≥ 10 are eligible. Patients with active tuberculosis or uncontrolled bacterial, fungal, viral, or other infection (besides SARS-CoV-2 virus) will be excluded from the study.

Conditions

• Covid-19

Interventions

Type	Name	Description
DRUG	Ruxolitinib	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

Timeline

• Start date: 2020-04-22
• Primary completion: 2021-07-15
• Completion: 2021-07-15
• First posted: 2020-04-08
• Last updated: 2021-08-13

Locations

6 sites across 1 country: Germany