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 : Unknown
Verified March 2020 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Active, not recruiting
First Posted : March 27, 2020
Last Update Posted : April 15, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Corona Virus Infection | Drug: Sarilumab | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 239 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Bayesian open labelled randomized clinical trial |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI |
Actual Study Start Date : | March 27, 2020 |
Estimated Primary Completion Date : | March 27, 2021 |
Estimated Study Completion Date : | December 31, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: SARILUMAB
Sarilumab (an IV dose of 400 mg of sarilumab in a 1 hour-infusion at D1).
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Drug: Sarilumab
(an IV dose of 400 mg of sarilumab in a 1 hour-infusion at D1 |
No Intervention: Standard of care
best standard of care
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- 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
- 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

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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 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

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): NCT04324073
France | |
Kremlin Bicetre hospital APHP | |
Le Kremlin-Bicêtre, Ile De France, France | |
Cochin Aphp | |
Paris, Ile De France, France | |
HEGP | |
Paris, Ile De France, France | |
NECKER Hospital | |
Paris, France, 75005 |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT04324073 |
Other Study ID Numbers: |
APHP200375-2 |
First Posted: | March 27, 2020 Key Record Dates |
Last Update Posted: | April 15, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Coronavirus Infections Virus Diseases Infections |
Coronaviridae Infections Nidovirales Infections RNA Virus Infections |