Treatment with Ruxolitinib in Covid-19 patients with severe symptoms

Phase 1

• Conditions: Covid-19 infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862

• Registration Number: EUCTR2020-001481-11-DE
• Lead Sponsor: Friedrich-Schiller-Universität Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-16
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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).
11. Hemoglobin < 6 g/dl (3.73mmol/l )
13. Pregnant or nursing (lactating) women.
14. Endstage pre-existing organ failure (cardiac, renal, pulmonary, hepatic, cerebrovascular) with survival probability < 6 months
15. Endstage malignancy with survival probability < 6 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified