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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 2

Conditions: Corona Virus Infection

Treatments: Drug: Tocilizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04331808

APHP200375-1

Details and patient eligibility

About

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.

Enrollment: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 4 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Tocilizumab

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

No Intervention group

Description:

Usual care was provided at the discretion of the clinicians

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

Experimental group

Description:

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

Treatment:

Drug: Tocilizumab

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

No Intervention group

Description:

Usual care was provided at the discretion of the clinicians