TOcilizumab and Covid-19 : Risk of Severe INfection

Covid19 Clinical Trial

— TOCSIN  

Official title:

TOcilizumab and Covid-19 : Risk of Severe INfection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05017441
• Other study ID #: TOCSIN
• Status: Recruiting
• Start date: August 16, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: François PHILIPPART, MD
• Phone: 144123085
• Email: fphilippart[@]ghpsj.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (6)

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. Erratum In: JAMA Netw Open. 2021 Jan 4;4(1):e2037904. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Digestive complication rate	This outcome corresponds to the number of patients who had digestive complications.	Day 90
Secondary	Rate of hematological complications	This outcome corresponds to the number of patients who had hematological complications.	Day 90
Secondary	Death rates	This outcome corresponds to the number of patients who died at D90.	Day 90
Secondary	Death rates	This outcome corresponds to the number of patients who died At D28.	Day 28