Status:
TERMINATED
Anti-il6 Treatment of Serious COVID-19 Disease With Threatening Respiratory Failure
Lead Sponsor:
Marius Henriksen
Conditions:
Corona Virus Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Coronavirus disease 2019 (COVID-19) is caused by the newly discovered coronavirus, SARS-CoV-2. The median time from onset of symptoms of COVID-19 to development of acute respiratory distress syndrome ...
Eligibility Criteria
Inclusion
- SARS-CoV-2 infection confirmed by real time-PCR and
- Positive imaging: consolidation, ground glass opacities, or bilateral pulmonary infiltration either by CT-scan or chest x-ray; and
- Need of oxygen therapy to maintain SO2\>94% OR FiO2/PaO2 \> 20 and at least two of the following laboratory measures:
- CRP level \>70 mg/L
- CRP level \>= 40 mg/L and doubled within 48 hours (without other confirmed infectious or non-infectious course),
- Lactatdehydrogenase \> 250 U/L,
- thrombocytopenia \< 120.000 x 10E9/L,
- lymphocyte count \< 0.6 x 10E9/L,
- D-dimer \> 1 ug/mL,
- serum ferritin \> 300 ug/mL
Exclusion
- pregnancy suspected or confirmed,
- severe heart failure,
- suspected or confirmed bacterial infection,
- current solid or hematological malignancy,
- neutropenia,
- ALAT elevation more than three times the laboratory upper limit,
- ASA class 5 (after COVID19 admission) or higher at inclusion (prior admission),
- severe chronic obstructive pulmonary disease or heart failure (NYHA class II or higher),
- pregnant or lactating women,
- current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents including IL-6 inhibitors, or with Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period,
- current use of chronic oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day,
- previous or active tuberculosis (TB),
- HIV infection regardless of immunological status, hepatitis,
- evidence of recent (30 days) invasive bacterial or fungal infections,
- patients who have received immunosuppressive antibody therapy within the past 5 months, including intravenous immunoglobulin or plans to receive during the study period,
- IV drug abuse,
- history of inflammatory bowel disease,
- diverticulitis,
- ulcer,
- perforated gastrointestinal tract,
- participation in any clinical research study evaluating an investigational product (IP) or therapy within 3 months and less than five half-lives of IP prior inclusion to the study,
- any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study,
- inability to give informed consent.
Key Trial Info
Start Date :
April 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04322773
Start Date
April 5 2020
End Date
October 8 2020
Last Update
October 9 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Bispebjerg-Frederiksberg Hospital
Copenhagen, Denmark, 2000
2
Hillerød Hospital
Hillerød, Denmark