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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-30

Study Completion Date

2020-11-09

Brief Summary

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The overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab 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 CORIMUNO-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.

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Detailed Description

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Conditions

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Corona Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TOCILIZUMAB -- Severe COVID Population (WHO Clinical Progression Scale =5 at baseline)

Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg) CPS: Clinical Progression Scale

Group Type EXPERIMENTAL

Tocilizumab

Intervention Type DRUG

Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)

Standard of care -- Severe COVID Population (WHO Clinical Progression Scale =5 at baseline)

Usual care was provided at the discretion of the clinicians

Group Type NO_INTERVENTION

No interventions assigned to this group

TOCILIZUMAB -- Critical COVID Population (WHO Clinical Progression Scale >5 at baseline)

Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg) CPS: Clinical Progression Scale

Group Type EXPERIMENTAL

Tocilizumab

Intervention Type DRUG

Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)

Standard of care -- Critical COVID Population (WHO Clinical Progression Scale >5 at baseline)

Usual care was provided at the discretion of the clinicians

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tocilizumab

Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)

Intervention Type DRUG

Eligibility Criteria

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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 Non Invasive Ventilation or High flow
* Group 2: Cases meeting all of the following criteria

* Respiratory failure AND (requiring mechanical ventilation OR Non Invasive Ventilation OR High flow)
* WHO progression scale \>=6
* No do-not-resuscitate order (DNR order)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No