Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19 (TOCIDEX)
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ClinicalTrials.gov Identifier: NCT04476979 |
Recruitment Status :
Completed
First Posted : July 20, 2020
Last Update Posted : June 8, 2022
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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 |
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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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 453 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 |
Actual Primary Completion Date : | June 1, 2021 |
Actual Study Completion Date : | August 11, 2021 |

Arm | Intervention/treatment |
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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)
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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) |
- 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.
- 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
- Overall survival at 14, 28, 60 and 90 days [ Time Frame: 14, 28, 60 and 90 days ]Overall survival
- Cumulative incidence of discharge alive at 14 and 28 days [ Time Frame: 14 and 28 days ]Cumulative incidence of discharge alive
- 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.
- Cumulative incidence of oxygen supply independency at 14 and 28 days [ Time Frame: 14 and 28 days ]Cumulative incidence of oxygen supply independency
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients included in the CORIMUNO-19 cohort
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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
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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

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
French Guiana | |
CH Andrée Rosemon | |
Cayenne, French Guiana |
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: | June 8, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
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 |
Infections Communicable Diseases Virus Diseases Coronavirus Infections Respiratory Tract Infections Severe Acute Respiratory Syndrome RNA Virus Infections Coronaviridae Infections Nidovirales Infections Respiratory Tract Diseases Disease Attributes Pathologic Processes |
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 |