Clinical Trial of Sarilumab in Adults With COVID-19 (SARICOR)

Maimónides Biomedical Research Institute of Córdoba

Status and phase: Completed; Phase 2

Conditions: SARS-CoV 2; SARS

Treatments: Drug: Best available treatment; Drug: Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]; Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]

Study type: Interventional

Funder types: Other

Identifiers

NCT04357860

SARICOR

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 3 patient groups

Sarilumab 200 mg

Experimental group

Description:

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

Treatment:

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

Sarilumab 400 mg

Experimental group

Description:

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

Treatment:

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

Control

Active Comparator group

Description:

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

Treatment:

Drug: Best available treatment