TOcilizumab and Covid-19 : Risk of Severe INfection

Study Overview
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Brief Summary
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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.

Official Title
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TOcilizumab and Covid-19 : Risk of Severe INfection

Conditions
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Covid19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient whose age ≥ 18 years French-speaking patient Patient with COVID-19 documented by PCR test or chest CT scan Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of infectious episodes during the hospitalization period | This outcome corresponds to occurrence of an infectious episode during hospitalization in a ward and/or intensive care unit. | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digestive complication rate | This outcome corresponds to the number of patients who had digestive complications. | Day 90 | 
| Rate of hematological complications | This outcome corresponds to the number of patients who had hematological complications. | Day 90 | 
| Death rates | This outcome corresponds to the number of patients who died at D90. | Day 90 | 
| Death rates | This outcome corresponds to the number of patients who died At D28. | Day 28 |