Evaluation of intranasal recombinant human interferon alfa-2b in the treatment of acute respiratory viral infections with mild clinical classification. Dose study. NASIRA studio. Phase II-III trial - IFNARI

Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点目标入组 608 人开始时间: 2022年12月6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.- Clinical diagnosis of ARI with mild symptoms (non-sustained fever = 38 ºC, cough, sore throat, sneezing, nasal congestion, mild headache, mild body pain, malaise, diarrhea and/or vomiting. White nasal discharge (clear) or transparent Radiology (Rx) normal Oxygen saturation greater than 95%). 2.- Age between 19 and 80 years, regardless of gender or skin color. 3.- Time not greater than 48 hours from the onset of clinical respiratory symptoms. 4.- Voluntary nature of the patient to participate in the trial.

•1.- Individuals under 19 years of age and over 80. 2.- Individuals with suspected clinical diagnosis of ARI with bacterial etiology. 3.- Individual with a clinical diagnosis of ARI with mild symptoms, without having started treatment in the 48 hours after the onset of symptoms. 4.- Individuals with ARI symptoms in moderate, severe or critical clinical classification. 5.- Individuals with decompensated chronic disease. 6.- Treatment with immunosuppressants in the last month prior to inclusion. 7.- Ongoing treatment, for any reason, with some IFN alpha formulation. 8.- Active use of any other medication or substance intranasally. 9.- Patient diagnosed with Myasthenia Gravis. 10.- Administration of any investigational drug in the 30 days prior to inclusion in the study. 11.- Individuals with hypersensitivity to thiomersal (thimerosal). 12.- Individuals with hypersensitivity to alpha interferon. 13.- Evident mental incapacity to issue consent and act accordingly with the study. 14.- Pregnancy, puerperium or lactation.

发起方

Center for Genetic Engineering and Biotechnology (CIGB)