Clinical Trial of Sarilumab in Adults With COVID-19

NCT ID: NCT04357860

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-28
• Study Completion Date: 2021-04-06

Brief 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.

Conditions

SARS-CoV 2; SARS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sarilumab 200 mg

Subjects treated with the best available treatment up to 14 days plus Sarilumab 200 mg single dose.

Group Type: EXPERIMENTAL

Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]

Intervention Type: DRUG

Best available treatment up to 14 days plus Sarilumab 200 mg

Sarilumab 400 mg

Subjects treated with the best available treatment up to 14 days plus Sarilumab 400 mg single dose.

Group Type: EXPERIMENTAL

Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]

Intervention Type: DRUG

Best available treatment up to 14 days plus Sarilumab 400 mg

Control

Subjects treated with the best available treatment up to 14 days.

Group Type: ACTIVE_COMPARATOR

Best available treatment

Intervention Type: DRUG

Best available treatment up to 14 days

Interventions

Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]

Best available treatment up to 14 days plus Sarilumab 200 mg

Intervention Type: DRUG

Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]

Best available treatment up to 14 days plus Sarilumab 400 mg

Intervention Type: DRUG

Best available treatment

Best available treatment up to 14 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Junta de Andalucia

OTHER_GOV

Sponsor Role: collaborator

Red Andaluza de Ensayos Clínicos en Enfermedades Infecciosas (Red ANCRAID)

UNKNOWN

Sponsor Role: collaborator

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julián de la Torre Cisneros, MD

Role: STUDY_DIRECTOR

Hospital Universitario Reina Sofía

Locations

Hospital Universitario Reina Sofía

Córdoba, , Spain

Countries

Spain

References

Merchante N, Carcel S, Garrido-Gracia JC, Trigo-Rodriguez M, Moreno MAE, Leon-Lopez R, Espindola-Gomez R, Alonso EA, Garcia DV, Romero-Palacios A, Perez-Camacho I, Gutierrez-Gutierrez B, Martinez-Marcos FJ, Fernandez-Roldan C, Perez-Crespo PMM, Cano AA, Leon E, Corzo JE, de la Fuente C, Torre-Cisneros J. Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial. Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0210721. doi: 10.1128/AAC.02107-21. Epub 2021 Dec 13.

Reference Type: DERIVED

PMID: 34902262 (View on PubMed)

Leon Lopez R, Fernandez SC, Limia Perez L, Romero Palacios A, Fernandez-Roldan MC, Aguilar Alonso E, Perez Camacho I, Rodriguez-Bano J, Merchante N, Olalla J, Esteban-Moreno MA, Santos M, Luque-Pineda A, Torre-Cisneros J. Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial. BMJ Open. 2020 Nov 14;10(11):e039951. doi: 10.1136/bmjopen-2020-039951.

Reference Type: DERIVED

PMID: 33191263 (View on PubMed)

Other Identifiers

SARICOR

Identifier Type: -

Identifier Source: org_study_id