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 人开始时间: 2020年11月23日最近更新: 2021年1月11日

适应症

试验速览

暂无简介。

•>= 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
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•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
•Being concurrently involved in another trial
•HIV infection (based on the anamnesis)
•Use of any antiretroviral medication
•Impaired renal function (eGFR calculated by CKD-EPI Creatinine equation < 30 ml/min);
•Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition);
•Any physical or psychological impediment in a patient that could let the investigator to suspect his/her poor compliance;
•Lack or withdrawal of informed consent

发起方

Istituto di Farmacologia Traslazionale - CNR