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Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19 (TOCIDEX)

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ClinicalTrials.gov Identifier: NCT04476979
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : April 19, 2021
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
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 Tocilizumab combined with Dexamethasone 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 Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort.

Tocilizumab will be administered to consenting adult patients hospitalized with COVID-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 (including Dexamethasone) treated patients


Condition or disease Intervention/treatment Phase
Coronavirus Infection SARS (Severe Acute Respiratory Syndrome) Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Respiratory Tract Infections Respiratory Tract Disease Drug: Tocilizumab Drug: Dexamethasone Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19
Actual Study Start Date : July 16, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dexamethasone
Dexamethasone : 10 mg once daily for the first five days (day 1 to day 5) then 5 mg per day for up to 5 days, 2.5mg per day for up to 4 days (or until oxygen supply independency if sooner)
 Drug: Dexamethasone
Dexamethasone : 10 mg once daily for the first five days (day 1 to day 5) then 5 mg per day for up to 5 days, 2.5mg per day for up to 4 days (or until oxygen supply independency if sooner)
Experimental: Dexamethasone + Tocilizumab

Dexamethasone : 10 mg once daily for the first five days (day 1 to day 5) then 5 mg per day for up to 5 days, 2.5mg per day for up to 4 days (or until oxygen supply independency if sooner)

+Tocilizumab 8mg/kg D1 and if no response (No decrease of oxygen requirement) a second fixed dose of 400mg wil be administered at D3

 Drug: Tocilizumab
Tocilizumab 8mg/kg D1 and if no response (No decrease of oxygen requirement) a second fixed dose of 400mg wil be administered at D3

Drug: Dexamethasone
Dexamethasone : 10 mg once daily for the first five days (day 1 to day 5) then 5 mg per day for up to 5 days, 2.5mg per day for up to 4 days (or until oxygen supply independency if sooner)


Outcome Measures
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Primary Outcome Measures :
  1. Survival without needs of invasive ventilation at day 14 [ Time Frame: day 14 ]
    Survival without needs of invasive ventilation at day 14. Thus, events considered are mechanical (invasive) ventilation or death. A new DNR order will be considered as an event at the actual date of care limitation.


Secondary Outcome Measures :
  1. WHO progression scale at day 7 and 14 [ Time Frame: day 7 and day 14 ]

    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. Overall survival at 14, 28, 60 and 90 days [ Time Frame: 14, 28, 60 and 90 days ]
    Overall survival

  3. Cumulative incidence of discharge alive at 14 and 28 days [ Time Frame: 14 and 28 days ]
    Cumulative incidence of discharge alive

  4. Survival without needs of mechanical ventilation at day 1 [ Time Frame: day 1 ]
    Survival without needs of mechanical ventilation at day 1. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.

  5. Cumulative incidence of oxygen supply independency at 14 and 28 days [ Time Frame: 14 and 28 days ]
    Cumulative incidence of oxygen supply independency

  6. Survival without needs of ventilator utilization at day 14 [ Time Frame: 14 days ]
    Survival without needs of ventilator utilization (including non-invasive ventilation and Optiflow) at day 14


Eligibility Criteria
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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 the following group:

    • Requiring ≥ 3L/min of oxygen
    • WHO progression scale = 5
    • No NIV or High flow

Exclusion Criteria:

  • Patients with exclusion criteria to the CORIMUNO-19 cohort.
  • Known hypersensitivity to Tocilizumab or DXM or to any of their excipients.
  • Pregnancy
  • Current documented bacterial infection not controlled by antibiotics.
  • certain evolving viral diseases (especially active herpes, chickenpox, shingles),
  • psychotic states still not controlled by treatment,
  • live vaccines in the previous 4 weeks,
  • Active tuberculosis or disseminated strongyloidiasis

  • 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): NCT04476979


Contacts
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Contact: Olivier HERMINE, PU-PH +33144495282 olivier.hermine@aphp.fr
Contact: Xavier MARIETTE, PU-PH +33145213758 xavier.mariette@aphp.fr

Locations
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French Guiana
CH Andrée Rosemon Recruiting
Cayenne, French Guiana
Contact: Félix DJOSSOU       felix.djossou@ch-cayenne.fr   
Principal Investigator: Félix DJOSSOU         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04476979    
Other Study ID Numbers: APHP200375-TOCIDEX
2020-001246-18 ( EudraCT Number )
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: July 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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Virus Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
RNA Virus Infections
Coronaviridae Infections
Nidovirales Infections
Respiratory Tract Diseases
Dexamethasone
 Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents