Anti-il6 treatment of serious COVID-19 disease with threatening respiratory failure
- Conditions
- SARS-CoV-2 infectionMedDRA version: 23.0Level: LLTClassification code 10070267Term: SARS virus test positiveSystem Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001275-32-DK
- Lead Sponsor
- The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
- SARS-CoV-2 infection confirmed by real time-PCR
- Positive imaging: consolidation, ground glass opacities, or bilateral pulmonary infiltration either by CT-scan or chest x-ray;
- Need of oxygen therapy to maintain SO2>94% OR FiO2/PaO2 < 22
- and at least two of the following laboratory parameters:
* CRP level >70 mg/L or CRP level >= 40 mg/L and doubled within 48 hours (without other confirmed infectious or non-infectious course),
* Lactatdehydrogenase > 250 U/L,
* thrombocytopenia < 120 x 10E9/L,
* lymphocyte count < 0.6 x 10E9/L,
* D-dimer > 1 ug/mL,
* serum ferritin > 300 ug/mL
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Age <18 years, pregnancy suspected or confirmed, severe heart failure, suspected or confirmed bacterial infection, current solid or haematological 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), 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of different types of IL-6 inhibition versus no adjuvant treatment compared to standard of care in patients with severe SARS-CoV-2 pneumonia. ;Secondary Objective: Not applicable;Primary end point(s): Time to independence from supplementary oxygen therapy in days ;Timepoint(s) of evaluation of this end point: Up to 28 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Number of deaths <br>2) Days out of hospital and alive at 28-day follow-up<br>3) Time to critical illness rate of subjects defined as requiring mechanical respiratory support (time frame: during treatment, 14 days, 28 days) <br>4) C-reactive protein (CRP) level (time frame: baseline, peak during treatment, 14 days, 28 days) <br>5) number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) (time frame: during treatment, 14 days, 28 days) <br>;Timepoint(s) of evaluation of this end point: up to 28 days