Intranasal use of recombinant human interferon alfa-2b in the treatment of patients with mild-stage COVID-19. Randomized comparison 5M-10M placebo controlled. (COVID-19) - NASALFERON-T

Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点目标入组 128 人开始时间: 2021年11月12日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•1. Virological diagnosis by RT-PCR of infection with SARS-CoV-2.
•2. Age between 19 and 80 years, without distinction of sex or skin color.
•3. Mild stage COVID-19 patients.
•4. Time no longer than 48 hours from the onset of clinical respiratory symptoms.
•5. Informed consent of the patient or legal representative

•1. Individual with PCR positive for SARS-CoV-2 without having started treatment within 48 hours after the onset of symptoms.
•2. Individuals under the age of 19 and over the age of 80.
•3. Individuals with COVID-19 in moderate, severe or critical stage.
•4. Individuals with decompensated chronic disease.
•5. Immunosuppressant treatment in the last month prior to enrollment.
•6. Ongoing treatment, for any cause, with any IFN formulation.
•7. Use of any other medication or substance intranasally.
•8. Patients with myasthenia gravis.
•9. Administration of an investigational drug in the 30 days prior to inclusion in the study.
•10. Individuals with hypersensitivity to thiomersal (thimerosal).
•11. Individuals with hypersensitivity to interferon alpha.
•12. Obvious mental incapacity to give consent and act accordingly with the study.
•13. Pregnancy, puerperium or lactation

发起方

Center for Genetic Engineering and Biotechnology (CIGB)