- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04331808
CORIMUNO-19 - Tocilizumab Trial - TOCI (CORIMUNO-TOCI) (CORIMUNO-TOC)
Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Tocilizumab Trial - CORIMUNO-19 - TOCI (CORIMUNO-TOCI)
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Paris, France
- APHP - Hopital Necker
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Paris, France, 75012
- APHP- Hôpital Tenon
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Paris, France
- APHP - Beaujon
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Paris, France
- Aphp - Bichat
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Paris, France
- APHP - Pitié Salpêtrière
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Paris, France
- APHP - Saint Louis
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Strasbourg, France
- CHU Strasbourg
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Villejuif, France
- Institut Gustave Roussy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients included in the CORIMUNO-19 cohort
Patients belonging to one of the 2 following groups:
Group 1: Cases meeting all of the following criteria
- Requiring more than 3L/min of oxygen
- OMS/WHO progression scale = 5
- No NIV or High flow
Group 2: Cases meeting all of the following criteria
- Respiratory failure AND (requiring mechanical ventilation OR NIV OR High flow)
- WHO progression scale >=6
- No do-not-resuscitate order (DNR order)
Exclusion Criteria:
- Patients with exclusion criteria to the CORIMUNO-19 cohort.
- Known hypersensitivity to Tocilizumab or to any of their excipients.
- Pregnancy
- Current documented bacterial infection
- Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication:
- Absolute neutrophil count (ANC) ≤ 1.0 x 109/L
- Haemoglobin level: no limitation
- Platelets (PLT) < 50 G /L
- SGOT or SGPT > 5N
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard of care
|
|
Experimental: TOCILIZUMAB
Tocilizumab 8mg/kg D1 and if no response (no decrease of oxygen requirement) a second injection at D3.
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Tocilizumab 8mg/kg D1 and if no response (no decrease of oxygen requirement) a second injection at D3.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival without needs of ventilator utilization at day 14. Group 1
Time Frame: 14 days
|
Group 1. Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14.
Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death.
New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.
|
14 days
|
WHO progression scale <=5 at day 4. Group 1.
Time Frame: 4 days
|
Group 1. Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5. WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10 |
4 days
|
Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14. Group 2.
Time Frame: 14 days
|
Group 2. Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation.
Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event.
|
14 days
|
WHO progression scale at day 4. Group 2.
Time Frame: 4 days
|
Group 2 Early end point : proportion of patients with a decrease of WHO score of at least 1 point at day 4. WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10 |
4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WHO progression scale
Time Frame: 7 and 14 days
|
WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10 |
7 and 14 days
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Survival
Time Frame: 14, 28 and 90 days
|
Overall survival
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14, 28 and 90 days
|
28-day ventilator free-days
Time Frame: 28 days
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28 days
|
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respiratory acidosis at day 4
Time Frame: 4 days
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arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours
|
4 days
|
PaO2/FiO2 ratio
Time Frame: day 1 to day 14
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evolution of PaO2/FiO2 ratio
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day 1 to day 14
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time to oxygen supply independency
Time Frame: 14 days
|
time to oxygen supply independency
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14 days
|
duration of hospitalization
Time Frame: 90 days
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duration of hospitalization
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90 days
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time to negative viral excretion
Time Frame: 90 days
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time to negative viral excretion
|
90 days
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time to ICU discharge
Time Frame: 90 days
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time to ICU discharge
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90 days
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time to hospital discharge
Time Frame: 90 days
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time to hospital discharge
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90 days
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Collaborators and Investigators
Publications and helpful links
General Publications
- Tleyjeh IM. The Misleading "Pooled Effect Estimate" of Crude Data from Observational Studies at Critical Risk of Bias: The Case of Tocilizumab in Coronavirus Disease 2019 (COVID-19). Clin Infect Dis. 2021 Jun 15;72(12):e1154-e1155. doi: 10.1093/cid/ciaa1735. No abstract available.
- Hermine O, Mariette X, Tharaux PL, Resche-Rigon M, Porcher R, Ravaud P; CORIMUNO-19 Collaborative Group. Effect of Tocilizumab vs Usual Care in Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jan 1;181(1):32-40. doi: 10.1001/jamainternmed.2020.6820. Erratum in: JAMA Intern Med. 2021 Jan 1;181(1):144. Erratum in: JAMA Intern Med. 2021 Jul 1;181(7):1021.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP200375-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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