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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARILUMAB -- Severe COVID population (WHO Clinical Progression Scale =5 at baseline) | Experimental | Sarilumab (an IV dose of 400 mg of sarilumab in a 1 hour-infusion at Day 1). Administration of Sarilumab fixed dose on day 3 was recommended and left to the treating physician |
|
| Standard of care -- Severe COVID population (WHO Clinical Progression Scale =5 at baseline) | No Intervention | Usual care was provided at the discretion of the clinicians | |
| SARILUMAB -- Critical COVID population (WHO Clinical Progression Scale >5 at baseline) | Experimental | Sarilumab (an IV dose of 400 mg of sarilumab in a 1 hour-infusion at Day 1). Administration of Sarilumab fixed dose on day 3 was recommended and left to the treating physician |
|
| Standard of care -- Critical COVID population (WHO Clinical Progression Scale >5) | No Intervention | Usual care was provided at the discretion of the clinicians |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarilumab | Drug | (an IV dose of 400 mg of sarilumab in a 1 hour-infusion at D1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With WHO Clinical Progression Scale > 5 at Day 4 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline) | Percentage of participants who has died or needed non-invasive or mechanical ventilation by day 4 (WHO clinical progression scale > 5). A patient with new do-not-resuscitate 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 | 4 days |
| Percentage of Participants With Non-invasive Ventilation, Mechanical Ventilation or Death at Day 14 (WHO Clinical Progression Scale =5 at Baseline) | Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Percentage of non-invasive ventilation, mechanical ventilation or death. Thus, events considered are needing ventilator utilization (mechanical or non-invasive ventilation including high flow oxygen), or death. New do-not-resuscitate (DNR) order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR. | Day 1 to Day 14 |
| Percentage of Participants With no Improvement in WHO Clinical Progression Scale at Day 4 -- Critical COVID Population ( WHO Clinical Progression Scale >5 at Baseline) | Results are presented as the percentage not improved, so that an effective treatment would be associated with a decrease in percentage 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Surviving (Overall Survival) | Percentage of participants surviving at 14, 28 and 90 days | 14, 28 and 90 days |
| WHO Progression Scale | 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 |
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Inclusion Criteria:
Patients included in the CORIMUNO-19 cohort
Patients belonging to one of the 2 following groups:
Moderate cases :
Cases meeting all of the following criteria:
Cases meeting any of the following criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NECKER Hospital | Paris | 75005 | France | |||
| Kremlin Bicetre hospital APHP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34812424 | Result | 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. 2022 Jan;4(1):e24-e32. doi: 10.1016/S2665-9913(21)00315-5. Epub 2021 Nov 17. | |
| 35115337 | Result | Hermine O, Mariette X, Porcher R, Resche-Rigon M, Tharaux PL, Ravaud P; CORIMUNO-19 Collaborative Group. Effect of interleukin-6 receptor antagonists in critically ill adult patients with COVID-19 pneumonia: two randomised controlled trials of the CORIMUNO-19 Collaborative Group. Eur Respir J. 2022 Aug 10;60(2):2102523. doi: 10.1183/13993003.02523-2021. Print 2022 Aug. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SARILUMAB -- Severe COVID Population (WHO-CPS =5) | Sarilumab (an IV dose of 400 mg of sarilumab in a 1 hour-infusion at Day 1). Administration of Sarilumab fixed dose on day 3 was recommended and left to the treating physician |
| FG001 | Standard of Care -- Severe COVID Population (WHO-CPS =5) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 4, 2020 | Jul 25, 2024 |
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Bayesian open labelled randomized clinical trial
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| 4 days |
| Cumulative Incidence (Percentage of Participants) With Successful Tracheal Extubation at Day 14 -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline) | 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 Non Invasive Ventilation or high flow (for > 48h) if they were included under oxygen by Non Invasive Ventilation or High flow (score 6) and remained without intubation. Death or new do-not-resuscitate order (if given after the inclusion of the patient) will be considered as a competing event. | Day 1 to Day 14 |
| 4, 7 and 14 days |
| Mean of Ventilator Free-days at Day 28 -- Critical COVID Population (WHO-clinical Progression Scale >5 at Baseline) | 28-day ventilator free-days | 28 days |
| Cumulative Incidence (Percentage of Participants) of Oxygen Supply Independency | Time to oxygen supply independency | 28, 90 days |
| Cumulative Incidence (Percentage of Participants) of Discharge From Hospital | Time to discharge from hospital | 28, 90 days |
| Cumulative Incidence (Percentage of Participants) of Intensive Care Unit Discharge -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline) | Time to discharge from Intensive Care Unit | 28, 90 days |
| PaO2/FiO2 Ratio -- Critical COVID Population (WHO-CPS >5) | evolution of PaO2/FiO2 ratio PaO2 is partial pressure of arterial oxygen expressed in mmHg. FiO2 is fraction of inspired oxygen (for instance, 0.33 for 33% oxygen) with no units. PaO2/FiO2 ratio is expressed in mmHg. | day 1 to day 14 |
| Le Kremlin-Bicêtre |
| ÃŽle-de-France Region |
| France |
| Cochin Aphp | Paris | ÃŽle-de-France Region | France |
| HEGP | Paris | ÃŽle-de-France Region | France |
| 41574613 | Derived | Lenoir O, Morin F, Walter-Petrich A, Resmini L, Zaidan M, Mahtal N, Ferlicot S, Puelles VG, Wanner N, Dang J, d'Izarny-Gargas T, Biermann J, Izar B, Baron S, Terrier B, Massy ZA, Essig M, Couturier A, May O, Belenfant X, Buob D, Brocheriou I, Izzedine H, Lombardi Y, Francois H, Moktefi A, Audard V, Sannier A, Daugas E, Jamme M, Henry G, Le Monnier de Gouville I, Marie C, Homyrda L, Verstuyft C, Tubiana S, Kafif O, Piquard V, Dougados M, Huber TB, Livrozet M, Hulot JS, Laouenan C, Ghosn J, Mentre F, Karras A, Yazdanpanah Y, Porcher R, Ravaud P, Caillat-Zucman S, Mariette X, Hermine O, Resche-Rigon M, Tharaux PL; CORIMUNO-19 collaborative group. Levels of circulating kidney injury markers and IL-10 identify non-critically ill patients with COVID-19 at risk of death. JCI Insight. 2026 Jan 23;11(2):e198244. doi: 10.1172/jci.insight.198244. eCollection 2026 Jan 23. |
| 38077399 | Derived | Joly C, Desjardins D, Porcher R, Pere H, Bruneau T, Zhang Q, Bastard P, Cobat A, Resmini L, Lenoir O, Savale L, Lecuroux C, Verstuyft C, Roque-Afonso AM, Veyer D, Baron G, Resche-Rigon M, Ravaud P, Casanova JL, Le Grand R, Hermine O, Tharaux PL, Mariette X. More rapid blood interferon alpha2 decline in fatal versus surviving COVID-19 patients. Front Immunol. 2023 Nov 21;14:1250214. doi: 10.3389/fimmu.2023.1250214. eCollection 2023. |
Usual care was provided at the discretion of the clinicians |
| FG002 | SARILUMAB -- Critical COVID Population (WHO-CPS >5) | Sarilumab (an IV dose of 400 mg of sarilumab in a 1 hour-infusion at Day 1). Administration of Sarilumab fixed dose on day 3 was recommended and left to the treating physician |
| FG003 | Standard of Care -- Critical COVID Population (WHO-CPS >5) | Usual care was provided at the discretion of the clinicians |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SARILUMAB -- Severe COVID Population (WHO-CPS =5) | Sarilumab (an IV dose of 400 mg of sarilumab in a 1 hour-infusion at Day 1). Administration of Sarilumab fixed dose on day 3 was recommended and left to the treating physician |
| BG001 | Standard of Care -- Severe COVID Population (WHO-CPS =5) | Usual care was provided at the discretion of the clinicians |
| BG002 | SARILUMAB -- Critical COVID Population (WHO-CPS >5) | Sarilumab (an IV dose of 400 mg of sarilumab in a 1 hour-infusion at Day 1). Administration of Sarilumab fixed dose on day 3 was recommended and left to the treating physician |
| BG003 | Standard of Care -- Critical COVID Population (WHO-CPS >5) | Usual care was provided at the discretion of the clinicians |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Body Mass Index >= 30 kg/m² | Missing data are possible | Count of Participants | Participants |
| ||||||||||
| Weight | Missing data are possible | Median | Inter-Quartile Range | kg |
| |||||||||
| SPO2 | Median | Inter-Quartile Range | % |
| ||||||||||
| Temperature | Median | Inter-Quartile Range | °C |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With WHO Clinical Progression Scale > 5 at Day 4 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline) | Percentage of participants who has died or needed non-invasive or mechanical ventilation by day 4 (WHO clinical progression scale > 5). A patient with new do-not-resuscitate 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 | Severe COVID Population (WHO-CPS =5) | Posted | Number | percentage of participants | 4 days |
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| Primary | Percentage of Participants With Non-invasive Ventilation, Mechanical Ventilation or Death at Day 14 (WHO Clinical Progression Scale =5 at Baseline) | Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Percentage of non-invasive ventilation, mechanical ventilation or death. Thus, events considered are needing ventilator utilization (mechanical or non-invasive ventilation including high flow oxygen), or death. New do-not-resuscitate (DNR) order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR. | Severe COVID population (WHO-CPS =5) | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to Day 14 |
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| Primary | Percentage of Participants With no Improvement in WHO Clinical Progression Scale at Day 4 -- Critical COVID Population ( WHO Clinical Progression Scale >5 at Baseline) | Results are presented as the percentage not improved, so that an effective treatment would be associated with a decrease in percentage 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 | Critical COVID Population (WHO-CPS >5) | Posted | Number | percentage of participants | 4 days |
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| Primary | Cumulative Incidence (Percentage of Participants) With Successful Tracheal Extubation at Day 14 -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline) | 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 Non Invasive Ventilation or high flow (for > 48h) if they were included under oxygen by Non Invasive Ventilation or High flow (score 6) and remained without intubation. Death or new do-not-resuscitate order (if given after the inclusion of the patient) will be considered as a competing event. | Critical COVID Population (WHO-CPS >5) | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to Day 14 |
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| Secondary | Percentage of Participants Surviving (Overall Survival) | Percentage of participants surviving at 14, 28 and 90 days | Posted | Number | 95% Confidence Interval | percentage of participants | 14, 28 and 90 days |
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| Secondary | WHO Progression Scale | 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 | Missing data are possible | Posted | Median | Inter-Quartile Range | score on a scale | 4, 7 and 14 days |
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| Secondary | Mean of Ventilator Free-days at Day 28 -- Critical COVID Population (WHO-clinical Progression Scale >5 at Baseline) | 28-day ventilator free-days | Critical COVID Population (WHO-CPS >5) | Posted | Mean | Standard Deviation | days | 28 days |
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| Secondary | Cumulative Incidence (Percentage of Participants) of Oxygen Supply Independency | Time to oxygen supply independency | Posted | Number | 95% Confidence Interval | percentage of participants | 28, 90 days |
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| Secondary | Cumulative Incidence (Percentage of Participants) of Discharge From Hospital | Time to discharge from hospital | Posted | Number | 95% Confidence Interval | percentage of participants | 28, 90 days |
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| Secondary | Cumulative Incidence (Percentage of Participants) of Intensive Care Unit Discharge -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline) | Time to discharge from Intensive Care Unit | Critical COVID Population (WHO-CPS >5) Patients in the ICU at inclusion | Posted | Number | 95% Confidence Interval | percentage of participants | 28, 90 days |
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| Secondary | PaO2/FiO2 Ratio -- Critical COVID Population (WHO-CPS >5) | evolution of PaO2/FiO2 ratio PaO2 is partial pressure of arterial oxygen expressed in mmHg. FiO2 is fraction of inspired oxygen (for instance, 0.33 for 33% oxygen) with no units. PaO2/FiO2 ratio is expressed in mmHg. | No statistical comparison was performed due to the limited number of patients with available follow-up data. | Posted | Median | Inter-Quartile Range | mmHg | day 1 to day 14 |
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Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.
Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SARILUMAB -- Severe COVID Population (WHO-CPS =5) | Sarilumab (an IV dose of 400 mg of sarilumab in a 1 hour-infusion at Day 1). Administration of Sarilumab fixed dose on day 3 was recommended and left to the treating physician | 10 | 68 | 27 | 68 | 0 | 0 |
| EG001 | Standard of Care -- Severe COVID Population (WHO-CPS =5) | Usual care was provided at the discretion of the clinicians | 16 | 76 | 28 | 76 | 0 | 0 |
| EG002 | SARILUMAB -- Critical COVID Population (WHO-CPS >5) | Sarilumab (an IV dose of 400 mg of sarilumab in a 1 hour-infusion at Day 1). Administration of Sarilumab fixed dose on day 3 was recommended and left to the treating physician | 14 | 48 | 31 | 48 | 0 | 0 |
| EG003 | Best Standard of Care -- Critical COVID Population (WHO-CPS >5) | Usual care was provided at the discretion of the clinicians | 13 | 33 | 19 | 33 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bacterial sepsis | Infections and infestations | Systematic Assessment |
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| Hepatic cytolisys | Hepatobiliary disorders | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Pulmonary embolism | Vascular disorders | Systematic Assessment |
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| Coronary syndrome | Cardiac disorders | Systematic Assessment |
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| Multiple organ failure | General disorders | Systematic Assessment |
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| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
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| Sudden death | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment |
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| Transient ischemic attack | Nervous system disorders | Systematic Assessment |
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| Hemorrhagic stroke | Nervous system disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Encephalitis | Nervous system disorders | Systematic Assessment |
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| Psoas hematoma | Vascular disorders | Systematic Assessment |
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| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Thrombophlebitis | Vascular disorders | Systematic Assessment |
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| Vasculitis of the limbs | Vascular disorders | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Ischemic stroke | Nervous system disorders | Systematic Assessment |
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| Hypernatremia | Renal and urinary disorders | Systematic Assessment |
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| Coronary ischemia | Cardiac disorders | Systematic Assessment |
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| Thrombotic microangiopathy | Vascular disorders | Systematic Assessment |
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| Valvular thrombosis | Vascular disorders | Systematic Assessment |
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| Acidosis | Renal and urinary disorders | Systematic Assessment |
| ||
| Allergy to Sarilumab | General disorders | Systematic Assessment |
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| Severe constipation | Gastrointestinal disorders | Systematic Assessment |
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| Accidental extubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cerebral hemorrhage | Nervous system disorders | Systematic Assessment |
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| Hyperkaliemia | Renal and urinary disorders | Systematic Assessment |
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| Neuromuscular abnormalities acquired in ICU | Nervous system disorders | Systematic Assessment |
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| Cardiac rythm disorder | Cardiac disorders | Systematic Assessment |
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| Diabetes | Endocrine disorders | Systematic Assessment |
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| Fungal sepsis | Infections and infestations | Systematic Assessment |
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| Lower limbs ischemia | Cardiac disorders | Systematic Assessment |
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| Heart failure | Cardiac disorders | Systematic Assessment |
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| Complication of tracheostomy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bone fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hypoalbuminemia | General disorders | Systematic Assessment |
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| Hypotension | Cardiac disorders | Systematic Assessment |
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| Transient ischemic attack | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Raphael Porcher | Hopital Hotel-Dieu (AP-HP) | +33(0)1.42.34.89.87 | raphael.porcher@aphp.fr |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2020 | Jul 25, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000592401 | sarilumab |
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| OG003 | Standard of Care -- Critical COVID Population (WHO-CPS >5) | Usual care was provided at the discretion of the clinicians |
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