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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 (CORIMUNO-SARI)

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ClinicalTrials.gov Identifier: NCT04324073
Recruitment Status : Active, not recruiting
First Posted : March 27, 2020
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE March 25, 2020
First Posted Date  ICMJE March 27, 2020
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE March 27, 2020
Estimated Primary Completion Date March 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • Survival without needs of ventilator utilization at day 14. [ Time Frame: 14 days ]
    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.
  • WHO progression scale <=5 at day 4 [ Time Frame: 4 days ]
    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
  • Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 [ Time Frame: 14 days ]
    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.
  • WHO progression scale at day 4 [ Time Frame: 4 days ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2020)
  • Survival without needs of ventilator utilization at day 14. [ Time Frame: 14 days ]
    Survival without needs of ventilator utilization (including Non invasive ventilation) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NVI), or death. New Do Not Resuscitate (DNR) order will be considered as an event at the date of the DNR.
  • WHO progression scale <=5 at day 4 [ Time Frame: 4 days ]
    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
  • Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 [ Time Frame: 14 days ]
    Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14. Death or DNR order will be considered as a competing event.
  • WHO progression scale <=7 at day 4 [ Time Frame: 4 days ]
    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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2020)
  • WHO progression scale [ Time Frame: 7 and 14 days ]
    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
  • Survival [ Time Frame: 14, 28 and 90 days ]
    Overall survival
  • 28-day ventilator free-days [ Time Frame: 28 days ]
  • respiratory acidosis at day 4 [ Time Frame: 4 days ]
    arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours
  • PaO2/FiO2 ratio [ Time Frame: day 1 to day 14 ]
    evolution of PaO2/FiO2 ratio
  • time to oxygen supply independency [ Time Frame: 14 days ]
    time to oxygen supply independency
  • duration of hospitalization [ Time Frame: 90 days ]
    duration of hospitalization
  • time to negative viral excretion [ Time Frame: 90 days ]
    time to negative viral excretion
  • time to ICU discharge [ Time Frame: 90 days ]
    time to ICU discharge
  • time to hospital discharge [ Time Frame: 90 days ]
    time to hospital discharge
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI
Official Title  ICMJE Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Bayesian open labelled randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Corona Virus Infection
Intervention  ICMJE Drug: Sarilumab
(an IV dose of 400 mg of sarilumab in a 1 hour-infusion at D1
Study Arms  ICMJE
  • Experimental: SARILUMAB
    Sarilumab (an IV dose of 400 mg of sarilumab in a 1 hour-infusion at D1).
    Intervention: Drug: Sarilumab
  • No Intervention: Standard of care
    best standard of care
Publications * CORIMUNO-19 Collaborative group. Sarilumab in adults hospitalised with moderate-to-severe COVID-19 pneumonia (CORIMUNO-SARI-1): An open-label randomised controlled trial. Lancet Rheumatol. 2021 Nov 17. doi: 10.1016/S2665-9913(21)00315-5. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 14, 2020)
239
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2020)
180
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date March 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04324073
Other Study ID Numbers  ICMJE APHP200375-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP