Antiviral and Immunomodulatory Interferon-Beta in high-risk COVID-19 patients - ANTIICIPATE

Istituto di Farmacologia Traslazionale - CNR0 个研究点目标入组 60 人2020年11月23日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: SARS-CoV 2 infection characterized by a National Early Warning Score lower or equal to 2 and symptoms present for less than 7 days
发起方: Istituto di Farmacologia Traslazionale - CNR
入组人数: 60
状态: 进行中（未招募）
最后更新: 5年前

暂无简介。

注册库

who.int

开始日期

2020年11月23日

结束日期

待定

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Istituto di Farmacologia Traslazionale - CNR

•\>\= 65 years of age at time of enrolment;
•Laboratory\-confirmed SARS\-CoV 2 infection as determined by PCR, in any specimen \< 72 hours prior to randomization
•Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures;
•Understands and agrees to comply with planned study procedures;
•Agrees to the collection of nasopharyngeal swabs and venous blood samples per protocol
•Being symptomatic for less than 7 days before starting therapy;
•NEWS score \=2
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) no

•Hospitalized patients with illness of any duration, and at least one of the following:
•\-Clinical assessment (evidence of rales/crackles on exam) AND SpO2 \= 94% on room air at rest or after walking test,
•\-Acute respiratory failure requiring mechanical ventilation and/or supplemental oxygen.
•Patients currently using interferon\-beta (e.g., multiple sclerosis patients);
•Patients treated with chemotherapy and/or immunosuppressive agents;
•Patients with chronic kidney diseases
•Known allergy or hypersensitivity to interferon (including asthma);
•Any autoimmune disease (resulting from patient anamnesis)
•Patients with signs of dementia or neurocognitive disorders
•Patients with current severe depression and/or suicidal ideations