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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04357860
Other study ID # SARICOR
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 28, 2020
Est. completion date April 6, 2021

Study information

Verified date April 2020
Source Maimónides Biomedical Research Institute of Córdoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Early administration of sarilumab in hospitalized patients infected with COVID-19 who have pulmonary infiltrates and are at high risk of unfavorable evolution could decrease/prevent progression to acute respiratory distress syndrome (ARDS) requiring high flow nasal oxygenation (HFNO) or either invasive or non-invasive mechanical ventilation.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date April 6, 2021
Est. primary completion date March 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Age = 18 years and <75 years - Admission for confirmed respiratory symptoms to COVID-19 based on a positive PCR in a sample of the respiratory tract in the local laboratory in the absence of respiratory distress syndrome requiring ONAF or mechanical ventilation - Interstitial pneumonia confirmed by chest radiography or CT - IL-6 levels> 40 pg / ml. In its absence, D-Dimer (DD)> 1500 or> 1000 may be included if progressive increases are documented - Negative pregnancy test in women of childbearing age - Signature of informed consent Exclusion Criteria: - SOFA score> 6 points - Patient who, in the researcher's opinion, is not a subsidiary of invasive mechanical ventilation - Neutrophil count <2 x 103 / µL - Platelet count <100 x 103 / µL - ALT or AST levels> 5 times the upper limit of normal - Severe renal failure (CrCr <30 ml / min) - Active bacterial infectious process - Active tuberculosis, history of not completing treatment against tuberculosis, suspicion of extrapulmonary tuberculosis - History of intestinal ulcer or diverticulitis - History of hypersensitivity reactions to Sarilumab or its excipients - Treatment with TNF antagonists - Previous treatment with anti-IL6 in the previous 30 days - Chronic prior treatment with corticosteroids at doses greater than 0.5 mg / kg / day of prednisone or equivalent. Yes, inhaled and topical corticosteroids are acceptable - Concomitant treatment with immunomodulators, among which are Vitamin D or statins. Macrolides such as azithromycin are acceptable - Patients on immunosuppressive treatment for any cause - HIV-infected patients with CD4 <200 / mm3 - Past or current history of autoimmune disease or systemic inflammatory disease - Patients who have received or are planning therapy with immunomodulatory antibodies, including immunoglobulins - Participation in any clinical trial that evaluated any investigational product in the last 3 months or less than 5 half-lives of the investigational product - Pregnancy - Any other condition that, in clinical judgment, prevents adherence to the patient's protocol

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]
Best available treatment up to 14 days plus Sarilumab 200 mg
Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]
Best available treatment up to 14 days plus Sarilumab 400 mg
Best available treatment
Best available treatment up to 14 days

Locations

Country Name City State
Spain Hospital Universitario Reina Sofía Córdoba

Sponsors (3)

Lead Sponsor Collaborator
Maimónides Biomedical Research Institute of Córdoba Consejería de Salud y Familias - Junta de Andalucía, Red Andaluza de Ensayos Clínicos en Enfermedades Infecciosas (Red ANCRAID)

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ventilation requirements Proportion of patients requiring or time (in days) until required:
High flow nasal oxygenation (HFNO)
Non-invasive mechanical ventilation type BiPAP
Non-invasive mechanical ventilation type CPAP
Invasive mechanical ventilation
At day 28 or when the subject is discharged (whichever occurs first)
Secondary Crude mortality Crude mortality at 28 days At day 28 or when the subject is discharged (whichever occurs first)
Secondary Time to clinical improvement Time to clinical improvement: defined as the mean change or time in days from randomization to any of the following criteria: (i) improvement of two points on the ordinal scale of 7 points of severity or, (ii) hospital discharge with lifetime. The criteria reached before are used. The 7 point gravity scale includes the following categories:
- Not hospitalized with normal activity
- Not hospitalized but unable to have normal activity
- Hospitalized, without requiring oxygen supplementation
- Hospitalized, requiring oxygen supplementation
- Hospitalized, requiring ONAF, non-invasive mechanical ventilation or both
- Hospitalized requiring ECMO, invasive mechanical ventilation or both
- Death
At day 28 or when the subject is discharged (whichever occurs first)
Secondary Time until improvement in oxygenation Time (in days) until improvement in oxygenation for at least 48 hours:
Time to verify an increase in the SpO2 / FiO2 ratio with respect to the worst SpO2 / FiO2 prior to treatment with Sarilumab and stratified according to levels of IL-6 or DD
Time to absence of oxygen requirement to maintain saturation in ambient air = 93%
Number of days in need of supplemental oxygen
At day 28 or when the subject is discharged (whichever occurs first)
Secondary Proportion of patients requiring invasive mechanical ventilation Proportion of patients requiring invasive mechanical ventilation in the trial At day 28 or when the subject is discharged (whichever occurs first)
Secondary Proportion of patients having negative COVID-19 CRP at each visit Proportion of patients having negative COVID-19 CRP at each visit of the trial At day 28 or when the subject is discharged (whichever occurs first)
Secondary Mean of serum cytokine levels Mean of serum cytokine levels: the panel of cytokines to quantify; IL1-??, IL1-ß, IL6, IL8, IL10, IL12, IL18, IL38, INF?, TNF??, CCL2, CCL3, CCL4, MIF and PAI-1 At day 28 or when the subject is discharged (whichever occurs first)
Secondary Adverse events related to medication and its administration Incidence of adverse events related to medication and its administration At day 28 or when the subject is discharged (whichever occurs first)
Secondary Incidence in the appearance of serious bacterial, fungal or opportunistic infections Incidence in the appearance of serious bacterial, fungal or opportunistic infections in the subjects At day 28 or when the subject is discharged (whichever occurs first)
Secondary Incidence of perforation of the gastrointestinal tract Incidence of perforation of the gastrointestinal tract in subjects At day 28 or when the subject is discharged (whichever occurs first)
Secondary Leukocyte and neutrophil count Leukocyte and neutrophil count mean At day 28 or when the subject is discharged (whichever occurs first)
Secondary Hemoglobin levels Mean hemoglobin levels At day 28 or when the subject is discharged (whichever occurs first)
Secondary Platelet count Platelet count mean At day 28 or when the subject is discharged (whichever occurs first)
Secondary Levels of creatinemia Average levels of creatinemia At day 28 or when the subject is discharged (whichever occurs first)
Secondary Bilirubin levels Average bilirubin levels At day 28 or when the subject is discharged (whichever occurs first)
Secondary ALT and AST levels ALT and AST average levels At day 28 or when the subject is discharged (whichever occurs first)
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