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CORIMUNO-19 - Tocilizumab Trial - TOCI (CORIMUNO-TOCI) (CORIMUNO-TOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04331808
Recruitment Status : Unknown
Verified March 2020 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
First Posted : April 2, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
The overall objective of the study is to determine the therapeutic effect and tolerance of Tocizilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Tocilizumab administration to patients enrolled in the COVIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.

Condition or disease Intervention/treatment Phase
Corona Virus Infection Drug: Tocilizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : March 30, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: TOCILIZUMAB
Tocilizumab 8mg/kg D1 and if no response (no decrease of oxygen requirement) a second injection at D3.
 Drug: Tocilizumab
Tocilizumab 8mg/kg D1 and if no response (no decrease of oxygen requirement) a second injection at D3.
No Intervention: Standard of care


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


  3. 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.

  4. 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



Secondary Outcome Measures :
  1. 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


  2. Survival [ Time Frame: 14, 28 and 90 days ]
    Overall survival

  3. 28-day ventilator free-days [ Time Frame: 28 days ]
  4. respiratory acidosis at day 4 [ Time Frame: 4 days ]
    arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours

  5. PaO2/FiO2 ratio [ Time Frame: day 1 to day 14 ]
    evolution of PaO2/FiO2 ratio

  6. time to oxygen supply independency [ Time Frame: 14 days ]
    time to oxygen supply independency

  7. duration of hospitalization [ Time Frame: 90 days ]
    duration of hospitalization

  8. time to negative viral excretion [ Time Frame: 90 days ]
    time to negative viral excretion

  9. time to ICU discharge [ Time Frame: 90 days ]
    time to ICU discharge

  10. time to hospital discharge [ Time Frame: 90 days ]
    time to hospital discharge


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients included in the CORIMUNO-19 cohort

  2. 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331808


Locations
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France
APHP- Hopital Tenon
Paris, France, 75012
APHP - Beaujon
Paris, France
APHP - Bichat
Paris, France
APHP - Hopital Necker
Paris, France
APHP - Pitié Salpêtrière
Paris, France
APHP - Saint Louis
Paris, France
CHU Strasbourg
Strasbourg, France
Institut Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04331808    
Other Study ID Numbers: APHP200375-1
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Virus Diseases
Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections