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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.
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with COVID-19 documented by PCR test or chest CT scan, treated in hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François PHILIPPART, MD | Contact | 144123085 | +33 | fphilippart@ghpsj.fr |
| Helene BEAUSSIER, PharmD, PhD | Contact | crc@ghpsj.fr |
| Name | Affiliation | Role |
|---|---|---|
| François PHILIPPART | Fondation Hôpital Saint-Joseph | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Paris Saint-Joseph | Recruiting | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33355679 | Background | Birgand G, Peiffer-Smadja N, Fournier S, Kerneis S, Lescure FX, Lucet JC. Assessment of Air Contamination by SARS-CoV-2 in Hospital Settings. JAMA Netw Open. 2020 Dec 1;3(12):e2033232. doi: 10.1001/jamanetworkopen.2020.33232. | |
| 32129805 | Background | Ong SWX, Tan YK, Chia PY, Lee TH, Ng OT, Wong MSY, Marimuthu K. Air, Surface Environmental, and Personal Protective Equipment Contamination by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) From a Symptomatic Patient. JAMA. 2020 Apr 28;323(16):1610-1612. doi: 10.1001/jama.2020.3227. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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 |
| 33753932 | Background | Leung NHL. Transmissibility and transmission of respiratory viruses. Nat Rev Microbiol. 2021 Aug;19(8):528-545. doi: 10.1038/s41579-021-00535-6. Epub 2021 Mar 22. |
| 14455113 | Background | KENDALL EJ, BYNOE ML, TYRRELL DA. Virus isolations from common colds occurring in a residential school. Br Med J. 1962 Jul 14;2(5297):82-6. doi: 10.1136/bmj.2.5297.82. No abstract available. |
| 29052924 | Background | Yin Y, Wunderink RG. MERS, SARS and other coronaviruses as causes of pneumonia. Respirology. 2018 Feb;23(2):130-137. doi: 10.1111/resp.13196. Epub 2017 Oct 20. |
| 32091533 | Background | Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available. |
| 41571778 | Derived | Lefevre C, Funck-Brentano T, Cachanado M, Plocque A, Youinou M, Fels A, Pene F, Savale L, Montani D, Voisin O, Bintein F, Wildenberg L, Philippe A, Legriel S, Roche N, Burgel PR, Tran M, Noel N, Baillard C, Duranteau J, Chatellier G, Philippart F. Benefit and risk associated with interleukin-6 receptor inhibitor administration during severe COVID-19: a retrospective multicentric study. Sci Rep. 2026 Jan 22;16(1):5978. doi: 10.1038/s41598-026-36864-w. |
| 35249968 | Derived | Sandhu G, Piraino ST, Piticaru J. Secondary Infection Risk in Patients With Severe COVID-19 Pneumonia Treated With Tocilizumab. Am J Ther. 2022 May-Jun 01;29(3):e275-e278. doi: 10.1097/MJT.0000000000001487. Epub 2022 Mar 4. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |