Informations générales (source: ClinicalTrials.gov)
TOcilizumab and Covid-19 : Risk of Severe INfection (TOCSIN)
Observational
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
août 2021
janvier 2024
29 juin 2024
SARS-CoV2 is responsible for a pandemic that has been evolving for approximately 18
months. The virus' capacity for dissemination and its virulence are responsible for
significant morbidity and mortality. The initial lack of knowledge of the pathogen and of
the pathophysiology underlying the potential severity of the disease, particularly in the
respiratory tract, led to numerous therapeutic attempts in this emergency context,
centered on the control of an obviously exaggerated inflammatory response. A large number
of studies remained of insufficient quality to lead to relevant and applicable
conclusions. Secondly, the benefit of corticosteroid therapy has been demonstrated in two
trials. Although Dexamethasone remains the only corticosteroid to improve survival, these
results have reinforced the hypothesis of the interest of treatments reducing the
inflammatory response, particularly cytokine. The widespread use, in the absence of
scientific data, of interleukin-6 receptor inhibitors (Sarilumab and Tocilizumab) has
been structured around studies whose results remain uncertain to this day because of the
heterogeneity of the population treated and the results observed. A possible survival
benefit seems to emerge for resuscitation patients who have not yet required invasive
ventilation, the other situations being probably associated with the absence of effect or
even the potential danger of this treatment. Tocilizumab is notably associated in the
literature with the risk of secondary infections and mucosal healing abnormalities,
favoring bleeding complications and digestive perforations. The objective of this study
is to evaluate the risk of digestive complications (hemorrhage, perforation,
diverticulitis) and infectious complications related to the use of Tocilizumab according
to the severity of the patients.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | François PHILIPPART | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patient whose age ≥ 18 years
- French-speaking patient
- Patient with COVID-19 documented by PCR test or chest CT scan
- Patient whose age ≥ 18 years
- French-speaking patient
- Patient with COVID-19 documented by PCR test or chest CT scan
- No confirmation of suspected COVID-19
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient objecting to the use of his/her data for this research