Treatment of COVID-19 patients with anti-interleukin drugs
- Conditions
- COVID-19 patients with acute hypoxic respiratory failure and systemic cytokine release syndrome.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001500-41-BE
- Lead Sponsor
- niversity Hospital Ghent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 342
-Recent (=6 days of flu-like symptoms or malaise yet =16 days of flu-like symptoms or malaise prior to
randomization) infection with COVID-19.Confident COVID-19 diagnosis confirmed by antigen detection
test and/or PCR and/or positive serology, or any emerging and validated diagnostic laboratory test for
COVID-19 within this period.
-In some patients, it may be impossible to get a confident laboratory confirmation of COVID-19
diagnosis after 24h of hospital admission because viral load is low and/or problems with diagnostic
sensitivity. In those cases, in absence of an alternative diagnosis, and with highly suspect bilateral
ground glass opacities on recent (<24h) chest-CT scan (confirmed by a radiologist and pulmonary
physician as probable COVID-19), and a typical clinical and chemical diagnosis with signs of cytokine
release syndrome, a patient can be enrolled as probable COVID-19 infected. In all cases, this needs
confirmation by later seroconversion.
-Presence of hypoxia defined as
PaO2/FiO2 below 350 while breathing room air in upright position or PaO2/FiO2 below 280 on
supplemental oxygen and immediately requiring high flow oxygen device or mechanical
ventilation.
-signs of cytokine release syndrome defined as
ANY of the following
-serum ferritin concentration >1000 mcg/L and rising since last 24h
-single ferritin above 2000 mcg/L in patients requiring immediate high flow oxygen device or
mechanical ventilation
-lymphopenia defined as <800 lymphocytes/microliter and two of the following extra criteria
Ferritin > 700 mcg/L and rising since last 24h
-increased LDH (above 300 IU/L) and rising since last 24h
-D-Dimers > 1000 ng/mL and rising since last 24h
-CRP above 70 mg/L and rising since last 24h and absence of bacterial infection
-if three of the above are present at admission, no need to document 24h rise
-Chest X-ray and/or CT scan showing bilateral infiltrates within last 2 days
-Admitted to specialized COVID-19 ward or an ICU ward taking care of COVID-19 patients
-Age = 18 years
-Male or Female
- Women of childbearing potential must have a negative serum pregnancy test pre-dose on day 1.
Women of childbearing potential must consistently and correctly use (during the entire treatment
period and 3 months after last reatment) 1 highly effective method for contraception.
-Willing and able to provide informed consent or legal representative willing to provide informed
consent
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 171
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 171
-Patients with known history of serious allergic reactions, including anaphylaxis, to any of the study medications, or any component of the product.
-mechanical ventilation > 24 h at randomization
-clinical frailty scale above 3
-active bacterial or fungal infection
-unlikely to survive beyond 48h
-neutrophil count below 1500 cells/microliter
-platelets below 50.000/microliter
-Patients enrolled in another investigational drug study
-patients on high dose systemic steroids (> 8 mg methylprednisolone or equivalent for more than 1 month) for COVID-19 unrelated disorder
-patients on immunosuppressant or immunomodulatory drugs
-patients on current anti-IL1 or anti-IL6 treatment
-signs of active tuberculosis
-serum transaminase levels >5 times upper limit of normal, unless there are clear signs of cytokine release syndrome defined by LDH >300 IU/L and ferritin >700 ng/ml
-history of (non-iatrogenic) bowel perforation or diverticulitis
- Pregnant or breastfeeding females (all female subjects deemed of childbearing potential by the investigator must have negative pregnancy test at screening)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method