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TOcilizumab and Covid-19 : Risk of Severe INfection

TOcilizumab and Covid-19 : Risk of Severe INfection

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05017441
Acronym
TOCSIN
Enrollment
1200
Registered
2021-08-23
Start date
2021-08-16
Completion date
2024-01-31
Last updated
2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Brief summary

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.

Interventions

None listed

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of infectious episodes during the hospitalization periodDay 90This outcome corresponds to occurrence of an infectious episode during hospitalization in a ward and/or intensive care unit.

Secondary

MeasureTime frameDescription
Digestive complication rateDay 90This outcome corresponds to the number of patients who had digestive complications.
Rate of hematological complicationsDay 90This outcome corresponds to the number of patients who had hematological complications.
Death ratesDay 90This outcome corresponds to the number of patients who died at D90.

Countries

France

Contacts

Primary ContactFrançois PHILIPPART, MD
fphilippart@ghpsj.fr144123085
Backup ContactHelene BEAUSSIER, PharmD, PhD
crc@ghpsj.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026