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Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI

Trial Profile

Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 16 Apr 2020

At a glance

  • Drugs Sarilumab (Primary)
  • Indications COVID 2019 infections; Pneumonia
  • Focus Therapeutic Use
  • Acronyms CORIMUNO-19-SARI; CORIMUNO-SARI
  • Most Recent Events

    • 14 Apr 2020 Status changed from recruiting to active, no longer recruiting.
    • 31 Mar 2020 Planned number of patients changed from 180 to 240.
    • 31 Mar 2020 Planned primary completion date changed from 26 Mar 2021 to 27 Mar 2021.

Trial Overview

Purpose

The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Sarilumab administration to patients enrolled in the CORIMUNO-19 cohort. Sarilumab 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 Sarilumab will receive standard of care. Outcomes of Sarilumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.

Primary Endpoints

Survival without needs of ventilator utilization at day 14.

description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.
time_frame: 14 days

WHO progression scale ≤5 at day 4

description: Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5.
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
time_frame: 4 days

Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14

description: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event.
time_frame: 14 days

WHO progression scale at day 4

description: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event.
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
time_frame: 4 days

Other Endpoints

WHO progression scale

description: 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
time_frame: 7 and 14 days

Survival

description: Overall survival
time_frame: 14, 28 and 90 days

28-day ventilator free-days

time_frame: 28 days

respiratory acidosis at day 4

description: arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours
time_frame: 4 days

PaO2/FiO2 ratio

description: evolution of PaO2/FiO2 ratio
time_frame: day 1 to day 14

time to oxygen supply independency

description: time to oxygen supply independency
time_frame: 14 days

duration of hospitalization

description: duration of hospitalization
time_frame: 90 days

time to negative viral excretion

description: time to negative viral excretion
time_frame: 90 days

time to ICU discharge

description: time to ICU discharge
time_frame: 90 days

time to hospital discharge

description: time to hospital discharge
time_frame: 90 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Pneumonia treatment moderate, severe

Subjects

  • Subject Type patients
  • Number

    Planned: 240

    Actual: 239

  • Sex male & female
  • Age Group ≥ 18 years

Patient Inclusion Criteria

1. Patients included in the CORIMUNO-19 cohort 2. Patients belonging to one of the 2 following groups: - Group 1: patients not requiring ICU at admission with moderate and severe pneumopathy according to the OMS Criteria of severity of COVID pneumopathy. Moderate cases : Cases meeting all of the following criteria: - Showing fever and respiratory symptoms with radiological findings of pneumonia. - Requiring between 3L/min and 5L/min of oxygen to maintain SpO2 >97% Severe cases Cases meeting any of the following criteria: - Respiratory distress (≧30 breaths/ min); - Oxygen saturation≤93% at rest in ambient air; or Oxygen saturation ≤97 % with O2 > 5L/min. - PaO2/FiO2≦300mmHg - Group 2: patients requiring ICU based on Criteria of severity of COVID pneumopathy. - Respiratory failure and requiring mechanical ventilation - No do-not-resuscitate order (DNR order)

Patient Exclusion Criteria

- Patients with exclusion criteria to the CORIMUNO-19 cohort. - Known hypersensitivity to Sarilumab 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 Details

Identifiers

Identifier Owner
NCT04324073 ClinicalTrials.gov: US National Institutes of Health
APHP200375-2 -

Trial Dates

  • Initiation Dates

    Planned : 26 Mar 2020

    Actual : 27 Mar 2020

  • Primary Completion Dates

    Planned : 27 Mar 2021

  • End Dates

    Planned : 31 Dec 2021

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase II/III
  • Location France
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
SarilumabPrimary Drug Intravenous Infusion

SARILUMAB

Sarilumab (an IV dose of 400 mg of sarilumab in a 1 hour-infusion at D1).
Drug: Sarilumab ((an IV dose of 400 mg of sarilumab in a 1 hour-infusion at D1)

Standard of care

best standard of care

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Matthieu RESCHE-RIGON, MD PhD
685740240 Ext: +33 matthieu.resche-rigon@u-paris.fr
show details
-
matthieu resche-rigon, MD-PhD
685740240 +33 matthieu.resche-rigon@u-paris.fr
show details
NECKER Hospital France
Olivier HERMINE, MD-PhD
603707920 Ext: +33 ohermine@gmail.com
show details
-
Xavier Mariette, MD-PHD Kremlin Bicetre hospital APHP France

Centres

Centre Name Location Trial Centre Country
-
-
-
Assistance Publique - Hôpitaux de Paris
-
-
Cochin Aphp Paris, Ile De France France
HEGP Paris, Ile De France France
Kremlin Bicetre hospital APHP Le Kremlin-Bicêtre, Ile De France France
NECKER Hospital Paris France

Trial History

Event Date Event Type Comment
16 Apr 2020 Other trial event Last checked against the ClinicalTrials.gov record. Updated 16 Apr 2020
14 Apr 2020 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 16 Apr 2020
31 Mar 2020 Other trial event Planned number of patients changed from 180 to 240. Updated 03 Apr 2020
31 Mar 2020 Other trial event Planned primary completion date changed from 26 Mar 2021 to 27 Mar 2021. Updated 03 Apr 2020
31 Mar 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 03 Apr 2020
30 Mar 2020 New trial record New trial record Updated 30 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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