临床试验/NCT07241975

NCT07241975已完成不适用

Real-world Experience With the Available Outpatient COVID-19 Therapies in Patients With Cancer: an Ambispective Cohort Study

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点分布在 1 个国家目标入组 112 人开始时间: 2022年8月23日最近更新: 2025年11月21日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 112
试验地点: 1
主要终点: evaluate the rate of hospitalization for COVID-19 disease within 14 days in the patients with cancer using COVID-19 early therapies as per indication.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The real-life efficacy of early antiviral therapies in cancer patients with COVID-19 is largely uncharacterized. From these unresolved issues, it is therefore necessary to fill these knowledge gaps by assessing the efficacy and safety of these therapies in combination with anti-cancer therapies.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients ≥ 18 years diagnosed with and/or treated for solid tumors at the department of Oncologia of the Fondazione IRCCS Policlinico San Matteo
•Prospective patients (or their or legal guardians) who have the ability to understand and be willing to sign a written informed consent document
•Retrospective patients who have signed the institutional document allowing the use of their data for research on their disease

排除标准

•Patients who are unable to understand informed consent document

结局指标

主要结局

evaluate the rate of hospitalization for COVID-19 disease within 14 days in the patients with cancer using COVID-19 early therapies as per indication.

时间窗: Data will be collected at T0 = start of COVID-19 therapy T1 = seven days after T0 T2 = 2 weeks after T0 T3 = one month after T0 T4 = + 3 months after T0 T5 = + 6 months after T0 T6 = + 12 months after T0

次要结局

To evaluate the mortality rate for COVID-19 disease(Data will be collected at T0 = start of COVID-19 therapy T1 = seven days after T0 T2 = 2 weeks after T0 T3 = one month after T0 T4 = + 3 months after T0 T5 = + 6 months after T0 T6 = + 12 months after T0)
To evaluate the time to COVID 19 symptoms resolution(Data will be collected at T0 = start of COVID-19 therapy T1 = seven days after T0 T2 = 2 weeks after T0 T3 = one month after T0 T4 = + 3 months after T0 T5 = + 6 months after T0 T6 = + 12 months after T0)
To evaluate the time to nasal swab viral clearance(Data will be collected at T0 = start of COVID-19 therapy T1 = seven days after T0 T2 = 2 weeks after T0 T3 = one month after T0 T4 = + 3 months after T0 T5 = + 6 months after T0 T6 = + 12 months after T0)
To evaluate the time of the re-start of the oncological treatment(Data will be collected at T0 = start of COVID-19 therapy T1 = seven days after T0 T2 = 2 weeks after T0 T3 = one month after T0 T4 = + 3 months after T0 T5 = + 6 months after T0 T6 = + 12 months after T0)
To evaluate the incidence of drug-related adverse events(Data will be collected at T0 = start of COVID-19 therapy T1 = seven days after T0 T2 = 2 weeks after T0 T3 = one month after T0 T4 = + 3 months after T0 T5 = + 6 months after T0 T6 = + 12 months after T0)
To evaluate the incidence of long COVID symptoms according to WHO case definition(Data will be collected at T0 = start of COVID-19 therapy T1 = seven days after T0 T2 = 2 weeks after T0 T3 = one month after T0 T4 = + 3 months after T0 T5 = + 6 months after T0 T6 = + 12 months after T0)

研究者

发起方

Fondazione IRCCS Policlinico San Matteo di Pavia

申办方类型

Other

责任方

Principal Investigator

主要研究者

Angioletta Lasagna

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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