TOcilizumab and Covid-19 : Risk of Severe INfection

NCT ID: NCT05017441

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2024-01-31

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.

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François PHILIPPART

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

Groupe Hospitalier Paris Saint-Joseph

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

François PHILIPPART, MD

Role: CONTACT

fphilippart@ghpsj.fr

144123085 ext. +33

Helene BEAUSSIER, PharmD, PhD

Role: CONTACT

crc@ghpsj.fr

Facility Contacts

François PHILIPPART

Role: primary

fphilippart@ghpsj.fr

144123085 ext. +33

References

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Reference Type: BACKGROUND

PMID: 33355679 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32129805 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33753932 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14455113 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29052924 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32091533 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35249968 (View on PubMed)

Other Identifiers

TOCSIN

Identifier Type: -

Identifier Source: org_study_id