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Completed

NCT Number: NCT04476979

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

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

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Key information

Conditions

Coronavirus Infection Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Respiratory Tract Disease Respiratory Tract Diseases Respiratory Tract Infections SARS (Severe Acute Respiratory Syndrome) Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CH Andrée Rosemon

Cayenne, French Guiana

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients included in the CORIMUNO-19 cohort
  • 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

Treatment and study plan

Tocilizumab

Drug

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

Dexamethasone

Drug

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)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: TOCIDEX

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2020
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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