Randomized open pilot study to evaluate the efficacy of subcutaneous sarilumab in patients with moderate-severe COVID-19 infection.

Rosario García de Vicuña0 个研究点目标入组 30 人开始时间: 2020年4月13日最近更新: 2022年8月8日

试验速览

暂无简介。

•1. Age> 18 years
•2. COVID-19 positive documented by PCR
•3. Documented interstitial pneumonia requiring admission and at least two of the following parameters:
•a. Fever = 37.8ºC in ear
•b. IL-6 in serum = 25 ng / mL (in the absence of a previous dose of prednisone or equivalent> 1 mg / kg) or PCR> 5mg / dL
•c. Lymphocytes <600 mm3
•d. Ferritin> 300 mcg / L that doubles in 24 hours
•e. Ferritin> 600 mcg / L in the first determination and LDH> 250 U / L
•f. D-dimer (> 1 mg / L)
•4. Informed verbal or administration consent under urgent conditions, documented in the medical record.
•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 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Patients who require mechanical ventilation at the time of inclusion.
•2. AST / ALT values greater than 5 times the upper limit of normal.
•3. Neutrophil values below 500 cells / mm3
•4. Platelet values of less than 50,000 cells / mm3
•5. Documented sepsis or high suspicion by pathogens other than COVID-19.
•6. Presence of comorbidities related, according to clinical judgment, with an unfavorable result.
•7. Complicated diverticulitis or intestinal perforation.
•8. Current skin infection (eg, uncontrolled dermopiodermitis).
•9. Immunosuppressive anti-rejection therapy.
•10. Pregnancy or lactation.
•11. Previous treatment with tocilizumab or sarilumab.
•12. Patients participating in some other clinical trial for SARS-CoV-2 infection.
•13. Patients with known hypersensitivity or contraindication to sarilumab or excipients.

发起方

Rosario García de Vicuña