RPCEC00000337已完成1 期
Intranasal administration of recombinant human interferon alfa-2b as prophylaxis of SARS-CoV-2 infection. (COVID-19)
Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 个研究点目标入组 80 人开始时间: 2020年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Prevention
入排标准
- 年龄范围
- 19 years 至 one(—)
- 性别
- All
入选标准
- •1) Individuals aged = 19 years.
- •2) Voluntariness of the subject by signing the informed consent.
排除标准
- •1) Virological diagnosis by RT-PCR of infection to SARS-CoV-2.
- •2) Treatment with immunosuppressants in the last month prior to inclusion.
- •3) Ongoing treatment, for any reason, with any IFN formulation.
- •4) Acute illnesses in the last 30 days.
- •5) Use of any other medication intranasally.
- •6) Subjects who underwent tonsillectomy.
- •7) History of allergic rhinitis and recurrent episodes of nasal bleeding.
- •8) Active chronic asthma.
- •9) Patients with myasthenia gravis.
- •10) Chronic, autoimmune or endocrine-metabolic diseases decompensated at the time of inclusion.
- •11) Administration of an investigational drug in the 30 days prior to inclusion in the study.
- •12) Known hypersensitivity to thiomersal and any of the components of the formulation under study.
- •13) Pregnancy or breastfeeding.
- •14) Obvious mental incapacity to issue consent and act accordingly with the study.
研究者
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