Evaluation of intranasal recombinant human interferon alfa-2b in the treatment of acute respiratory viral infections with mild clinical classification. Dose and frequency study. INDIRA study. Phase II-III trial - NASALFERON-ARI

Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点目标入组 495 人开始时间: 2022年7月29日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

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 AKI with mild symptoms (non-sustained fever = 38 ºC, cough, sore throat, sneezing, nasal congestion, mild headache, mild body aches, 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 sex or skin color.
•3.- Time not greater than 48 hours from the onset of clinical respiratory symptoms.
•4.- Willingness 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 AKI with bacterial etiology.
•3.- Individual with a clinical diagnosis of AKI with mild symptoms, without having started treatment within 48 hours after the onset of symptoms.
•4.- Individuals with symptoms of AKI in moderate, severe or critical clinical classification.
•5.- Individuals with chronic decompensated disease.
•6.- Treatment with immunosuppressants in the last month prior to inclusion.
•7.- Ongoing treatment, for any reason, with any formulation of IFN alpha.
•8.- Active use of some other drug or substance intranasally.
•9.- Patient diagnosed with Myasthenia Gravis.
•10.- Administration of an investigational drug in the 30 days prior to inclusion in the study.
•11.- Individuals with hypersensitivity to thiomersal (thimerosal).
•12.- Individuals with hypersensitivity to interferon alfa.
•13.- Evident mental inability to give consent and act accordingly with the study.
•14.- Pregnancy, puerperium or lactation.

发起方

Center for Genetic Engineering and Biotechnology (CIGB)