Status:
UNKNOWN
Serum IL-6 and Soluble IL-6 Receptor in Severe COVID-19 Pneumonia Treated With Tocilizumab
Lead Sponsor:
University Hospital for Infectious Diseases, Croatia
Conditions:
COVID-19
Severe Pneumonia
Eligibility:
All Genders
18+ years
Brief Summary
This is a single arm, prospective, observational, single center study to assess the role of interleukin-6 (IL-6) and soluble interleukin 6 receptor (sIL-6R) as predictors of efficacy and safety outcom...
Detailed Description
Patients must be at least 18 years of age with severe COVID-19 pneumonia (and/or ARDS) confirmed per World Health Organization (WHO) criteria, and evidence of pulmonary infiltration (by chest X-ray an...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative
- Age ≥18years at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator's judgment
- Hospitalized due to severe COVID-19 pneumonia (and/or ARDS) confirmed per World Health Organization criteria, and evidence of pulmonary infiltration (by chest X-ray and/or CT scan), including a virological confirmation of SARS-CoV-2 infection by positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid
- Hypoxemia (defined as a PaO2/FiO2 ratio ≤300 mmHg and/or SpO2≤93%) regardless of their oxygenation device (including low-flow oxygen administration on nasal cannula or mask with oxygen flow rate of \> 12 liters per minute), high-flow oxygen through nasal cannula, noninvasive ventilation (NIV) whatever the modalities of ventilation, invasive ventilation through tracheal intubation or tracheostomy, and extracorporeal oxygenation, despite being on SOC, which may include anti-viral treatment, low dose steroids, and supportive care
Exclusion
- Known severe allergic reactions to TCZ or other monoclonal antibodies
- Active TB infection
- Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
- Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 6 months
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>10 times the upper limit of the normality detected within 24 hours at screening or at baseline
- absolute neutrophil count (ANC) \<1000/µL at screening and baseline
- Platelet count \<50,000/µL at screening and baseline
- Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
- Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in the study
Key Trial Info
Start Date :
June 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 15 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04359667
Start Date
June 16 2020
End Date
May 15 2021
Last Update
November 12 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital for Infectious Diseases "Dr Fran Mihaljevic"
Zagreb, Croatia, 10000