Status:
UNKNOWN
Efficacy and Safety of Tocilizumab in the Treatment of SARS-Cov-2 Related Pneumonia
Lead Sponsor:
University of L'Aquila
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Brief Summary
The current spread of the COrona VIrus Disease-2019 (COVID-19) epidemic in Italy, and the current lack of effective and approved drugs for its treatment, poses the problem of Severe acute respiratory ...
Eligibility Criteria
Inclusion
- All gender patients aged ≥ 18 years;
- Patients with SARS-CoV-2 infection confirmed by tests (RT-PCR) and pulmonary involvement, hospitalized, at the end of the initial phase of high viral load of COVID-19 (apyretic\> 72 hours and / or at least 7 days after onset of symptoms);
- Worsening of respiratory exchanges such as to require non-invasive or invasive ventilation support (BCRSS score ≥ 3).
- High levels of IL-6 (\> 40 pg/mL) or alternatively CRP and/or ferritin and/or D-dimer and/or fibrinogen values higher than the reference values or rapidly increasing;
- Signature of informed consent.
Exclusion
- Alanine aminotransferase and/or Aspartate aminotransferase (ALT / AST) \> 5 times compared to normal laboratory values.
- Presence of a chronic renal failure ≥ 4 stage (glomerular filtrate values \<30 ml/min/1.73 m2).
- Presence of neutropenia (neutrophils count \< 500 / mm3).
- Platelet count less than 50 x 103/μL.
- Documented sepsis from other pathogens other than SARS-CoV-2.
- Presence of co-morbidities associated, in clinical judgment, with an unfavourable outcome.
- Complicated diverticulitis and / or intestinal perforation.
- Skin infection in progress (e.g. dermohypodermitis not controlled by antibiotic therapy).
- Immuno-suppressive anti-rejection therapy.
- Pregnancy or woman of childbearing age who does not use contraceptive and/or breastfeeding measures.
- Previous ischemic attack or myocardial infarction.
- NYHA class III or IV heart failure.
- Severe depressive syndrome or other psychiatric disease which, in the opinion of the doctor, can preclude patient participation in the study.
- Presence of known malignant neoplasms.
- Clinically significant history of alcohol abuse or drug addiction which, in the opinion of the doctor, may preclude the subject's participation in the study.
- Any condition which, in the opinion of the doctor, precludes the possibility of using the study drug provided for in the RCP.
- Any other laboratory condition or parameter that, in the doctor's judgment, precludes the subject's participation in the study.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04332913
Start Date
April 1 2020
End Date
March 31 2021
Last Update
April 13 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale San Salvatore
L’Aquila, Italy, 67100