Clinical Trial of Sarilumab in Adults With COVID-19

NCT04357860 | Completed Phase 2 DMC

• 1 other identifier: SARICOR
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Crude mortality

  At day 28 or when the subject is discharged (whichever occurs first)

• Time to clinical improvement

  At day 28 or when the subject is discharged (whichever occurs first)

• Time until improvement in oxygenation

  At day 28 or when the subject is discharged (whichever occurs first)

• Proportion of patients requiring invasive mechanical ventilation

  At day 28 or when the subject is discharged (whichever occurs first)

• Proportion of patients having negative COVID-19 CRP at each visit

  At day 28 or when the subject is discharged (whichever occurs first)

Study Arms (3)

Sarilumab 200 mg

EXPERIMENTAL

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

Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]

Sarilumab 400 mg

EXPERIMENTAL

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

Drug: Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]

Control

ACTIVE COMPARATOR

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

Drug: Best available treatment

Interventions

Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA] DRUG

Best available treatment up to 14 days plus Sarilumab 200 mg

Sarilumab 200 mg

Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA] DRUG

Best available treatment up to 14 days plus Sarilumab 400 mg

Sarilumab 400 mg

Best available treatment DRUG

Best available treatment up to 14 days

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead
• Junta de Andalucia: collaborator
• Red Andaluza de Ensayos Clínicos en Enfermedades Infecciosas (Red ANCRAID): collaborator

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Related Publications (2)

• 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.

  PMID: 34902262 DERIVED

• 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.

  PMID: 33191263 DERIVED

MeSH Terms

Interventions

sarilumab

Study Officials

• Julián de la Torre Cisneros, MD

  Hospital Universitario Reina Sofía

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: April 28, 2020
• Primary Completion: March 9, 2021
• Study Completion: April 6, 2021
• Last Updated: July 7, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the end of the trial.
• Access Criteria: Contact uicec@imibic.org

Locations

ES (1)