Efficacy and safety of sarilumab in the early treament of hospitalized patients with mild-moderate neumonia and COVID19 infection versus standard of care

Efficacy and safety of sarilumab in the early treament of hospitalized patients with mild-moderate neumonia and COVID19 infection versus standard of care - SARICOVID

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001290-74-ES

Enrollment

216

Registered

2020-04-13

Start date

2020-04-11

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with confirmed COVID-19 infection and criteria for mild-moderate pneumonia (CURB-65 =1 i SatO2 =90%, MEWS score less than 3) and IL6 values of 20 pg / ml, will be randomly assigned to a sarilumab treatment group or another group receiving treatment according to the current therapeutic protocol of the PSMAR. MedDRA version: 21.1 Level: PT Classification code 10035737 Term: Pneumonia viral System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Kevzara Product Name: Kevzara Product Code: 1171196003 Pharmaceutical Form: Solution for injection INN or Proposed INN: SARILUMAB Other descriptive name: EU/1/17/1196/012 Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - more than18 years - diagnostic confirmation of COVID19 infection (PCR) and radiological diagnosis of pneumonia - MEWS less than 3 and CURB 65 less than or equal to 1, IL6 greater than or equal to 20 pg / mL. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 36

Exclusion criteria

Exclusion criteria: - AST / ALT> 5 X LSN - neutrophils <500 cell / mm3 - lymphocytes <400 cell - Platelets <50,000 cell / mm3 - creatinine clearance (CCL) <30 mL / min - Documented sepsis and active infection by other pathogens other than COVID-19 - presence of comorbidities that may lead to a poor prognosis according to clinical criteria - Complicated diverticulitis or intestinal perforation - Ongoing skin infection (eg uncontrolled pyodermitis with antibiotic treatment) - anti rejection immunosuppressive therapy - Other biological treatments - At the investigator's discretion, survival less than 48 hours from screening - Treatment with anti-IL 6, anti-IL-6R antagonists or with Janus kinase inhibitors (JAKi) in the last 30 days or plans to receive during the study period - Current treatment with conventional synthetic disease modifying antirheumatic drugs (DMARDs) / immunosuppressive agents - History of current systemic or localized autoimmune or inflammatory diseases, other than rheumatoid arthritis - Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections - Patients who have received immunosuppressive antibody therapy in the last 5 months, including intravenous immunoglobulin, or who plan to receive it during the study period. - Participation in any clinical research study evaluating a research product or therapy (PI) within 3 months and less than 5 PI half-lives before the screening visit (The use of remdisivir in the context of a compassionate use remdisivir one-arm is allowed) - Pregnancy - hypersensitivity to Sarilumab and / or to some of its excipients. - Any finding of the physical examination and / or history of any disease that, in the opinion of the study investigator, may confuse the study results or represent an additional risk for the patient due to their participation in the study.

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 28 days;Main Objective: To assess the efficacy and safety of early treatment of sarilumab, added to standard treatment, in patients hospitalized for mild-moderate COVID-19 pneumonia, with criteria of a CURB 65 less than or equal to 1, oxygen saturation equal to or greater than 90%, MEWS less than 3 and with IL6 greater than 20 pg / mL.;Secondary Objective: To evaluate: -Clinical status of patients on days 7 and 14 later than the treatment initiation. -Proportion of patients discharged on day 14 -28-day mortality rate -Proportion of patients who required mechanical ventilation and days of duration -Days of hospital stay of patients who have survived to 28 days -Time since start of treatment to death of the patient -Possible serious adverse events related to sarilumab and possible causes of discontinuation of sarilumab treatment to analyze: -type of medications received during admission and days since onset of symptoms to starting glucocorticoids -the evolution of prognostic factors: IL6, D-dimer, ferritin, calprotectin;Primary end point(s): Time to clinical improvement, defined as the time from randomization to a two-point improvement (from randomization status) on an ordinal scale of seven categories or hospital discharge, whichever occurs first. The seven-category ordinal scale consisted of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7, death.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 28 days;Main Objective: To assess the efficacy and safety of early treatment of sarilumab, added to standard treatment, in patients hospitalized for mild-moderate COVID-19 pneumonia, with criteria of a CURB 65 less than or equal to 1, oxygen saturation equal to or greater than 90%, MEWS less than 3 and with IL6 greater than 20 pg / mL.;Secondary Objective: To evaluate: -Clinical status of patients on days 7 and 14 later than the treatment initiation. -Proportion of patients discharged on day 14 -28-day mortality rate -Proportion of patients who required mechanical ventilation and days of duration -Days of hospital stay of patients who have survived to 28 days -Time since start of treatment to death of the patient -Possible serious adverse events related to sarilumab and possible causes of discontinuation of sarilumab treatment to analyze: -type of medications received during admission and days since onset of symptoms to starting glucocorticoids -the evolution of prognostic factors: IL6, D-dimer, ferritin, calprotectin;Primary end point(s): Time to clinical improvement, defined as the time from randomization to a two-point improvement (from randomization status) on an ordinal scale of seven categories or hospital discharge, whichever occurs first. The seven-category ordinal scale consisted of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7, death.

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Secondary

Measure	Time frame
Secondary end point(s): - Clinical status evaluated with the ordinal scale of seven categories on days 7 and 14 - 28-day mortality - Mechanical ventilation (yes / no) - Duration of mechanical ventilation - Duration of hospitalization of those who survive (discharge date will be recorded, which is recorded in the report in the patient's medical history) - time (in days) from the start of treatment until death. - medication during the study period: vasopressors, renal replacement therapy, non-invasive mechanical ventilation, invasive mechanical ventilation, ECMO, antibiotics, glucocorticoids, others. - Days from the beginning of the disease to the start of corticosteroid use - Days of corticosteroid treatment. - Interleukin 6 basal, at 12 hours, 24 hours, 48 ??hours, at 72 and at 7 days - Baseline D-dimer, at 12 hours, 24 hours, 48 ??hours, at 72 and 7 days Security variables: - Adverse events that occurred during treatment, - Grade 3 and grade 4 serious adverse events - Serious and unexpected adverse reactions. - Causes of premature interruption of treatment.;Timepoint(s) of evaluation of this end point: clinical status at, 7, 14 and 28 days laboratory variables: at 12 hours, 24 hours, 48 ??hours, at 72 and 7 days	—

Measure

Time frame

Secondary end point(s): - Clinical status evaluated with the ordinal scale of seven categories on days 7 and 14 - 28-day mortality - Mechanical ventilation (yes / no) - Duration of mechanical ventilation - Duration of hospitalization of those who survive (discharge date will be recorded, which is recorded in the report in the patient's medical history) - time (in days) from the start of treatment until death. - medication during the study period: vasopressors, renal replacement therapy, non-invasive mechanical ventilation, invasive mechanical ventilation, ECMO, antibiotics, glucocorticoids, others. - Days from the beginning of the disease to the start of corticosteroid use - Days of corticosteroid treatment. - Interleukin 6 basal, at 12 hours, 24 hours, 48 ??hours, at 72 and at 7 days - Baseline D-dimer, at 12 hours, 24 hours, 48 ??hours, at 72 and 7 days Security variables: - Adverse events that occurred during treatment, - Grade 3 and grade 4 serious adverse events - Serious and unexpected adverse reactions. - Causes of premature interruption of treatment.;Timepoint(s) of evaluation of this end point: clinical status at, 7, 14 and 28 days laboratory variables: at 12 hours, 24 hours, 48 ??hours, at 72 and 7 days

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Countries

Spain

Contacts

Public ContactAna Aldea

Consorci PSMAR

aaldea@imim.es+34933160490

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026