Ruxolitinib in Covid-19 Patients With Defined Hyperinflammation
- Sponsor
- University of Jena
- Study ID
- NCT04338958
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ruxolitinib — DRUG2 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
Study Details
RuxCoFlam is a single arm, non-randomized open phase II trial for front line treatment of Covid-19 patients with defined hyperinflammation.
Key Dates
- Start date
- Apr 22, 2020
- Status verified
- Aug 2021
- Primary completion
- Jul 15, 2021
- Completion
- Jul 15, 2021
Study Design
- Enrollment
- 193 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Ruxolitinib2 x 10mg Ruxolitinib with defined response adapted dose escalation up to 2 x 20mg for a duration of 7 days
Primary Outcome Measure
overall response rate in reversal of hyperinflammation [ Time Frame: day 7 after start of therapy ]
Related Studies
- Viral Infections in Healthy and Immunocompromised HostsRecruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Bethesda, Maryland
- Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT StudyPHASE3 · Recruiting · Ansun Biopharma, Inc. · Duarte, California
- Positron Emission Tomography (PET) Imaging of ThrombosisPHASE1 · Recruiting · Massachusetts General Hospital · Boston, Massachusetts
- Impact of the Coronavirus (COVID-19) on Patients With CancerRecruiting · Stanford University · Stanford, California