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Clinical Trials/EUCTR2020-001481-11-DE
EUCTR2020-001481-11-DE
Active, not recruiting
Phase 1

Front line treatment with Ruxolitinib in stage II/III Covid-19 patients with defined Hyperinflammation - RuxCoFlam

Friedrich-Schiller-Universität Jena0 sites200 target enrollmentApril 16, 2020
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ConditionsCovid-19 infectionMedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsJakavi

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Covid-19 infection
Sponsor
Friedrich-Schiller-Universität Jena
Enrollment
200
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 16, 2020
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Patient or guardian must provide written informed consent (and assent if applicable) before any study assessment is performed.
  • •2\. Male and female patients aged \= 18 years.
  • •3\. Patients with temperature \> 37\.3°C
  • •4\. Patients with respiratory symptoms and/or hypoxia SpO2 \< 93%
  • •5\. Patients with Covid\-19 stage II and stage III
  • •6\. Patients with lung imaging showing bi\-pulmonary infiltrates (chest X\-ray or CT scan).
  • •7\. Patients, with a Covid Inflammation Score \= 10
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •1\. History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.
  • •2\. Uncontrolled active bacterial, fungal, viral, or other infection (besides COVID\-19\).
  • •3\. Active Tuberculosis infection.
  • •4\. Known Positivity for HBV, HCV or HIV.
  • •5\. Patients who are on long\-term use of oral anti\-rejection or immunomodulatory drugs 1\.
  • •6\. Participating in any other interventional clinical trial for COVID\-19 .
  • •7\. 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.
  • •8\. ALT or AST \> 5 x ULN detected within 24 hours at screening (according to local laboratory reference ranges).
  • •9\. ANC \< 500/µL at screening (according to local laboratory reference ranges).
  • •10\. Platelet count \< 50,000/µL at screening (according to local laboratory reference ranges).

Outcomes

Primary Outcomes

Not specified

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