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临床试验/NCT04654416
NCT04654416已完成不适用

Clinical Outcome of Patients With COVID-19 Pneumonia Treated With Corticosteroids and Colchicine in Colombia

Clínica Medellín - Grupo Quirónsalud1 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2020年3月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
301
试验地点
1
主要终点
Outcome

研究概览

简要总结

Cross sectional study of 301 adult patients with Covid-19 Pneumonia treated with corticosteroid and/or colchicine

详细描述

A cross sectional study of 301 adult patients with Covid-19 Pneumonia confirmed by Real-Time Polymerase Chain Reaction for SARS-CoV2 (RT-PCR SARS-CoV2), Berlin protocol, who required hospitalization in three hospitals in Antioquia, Colombia. Patients were treated according to the institutional protocol (from March 20, 2020 to June 30, 2020) with corticosteroid if the patient required supplemental oxygen. From July 1, 2020, the management protocol changed with the addition of colchicine to all patients admitted to the institutions. The treatment was supervised and monitored by the same specialist in infectology of the institutions.

We describe the clinical manifestations and outcomes of the patients who received these treatments. The patient's information was analyzed according to the outcome of interest (alive/dead) with univariate, bivariate, and multivariate measures to adjust the variables that presented statistical association.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

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

入选标准

  • The included patients were older than 18 years hospitalized for Covid-19 Pneumonia, confirmed positive by Real-Time Reverse Transcription Polymerase Chain Reaction for SARS-CoV2 (RT-PCR SARS-Cov2) by Berlin protocol. The samples were taken from a nasopharyngeal swab.
  • The patients should also have radiological confirmation of Pneumonia, mostly chest tomography or chest X-rays, to support the diagnosis of Covid-19 Pneumonia.

排除标准

  • 未提供

研究组 & 干预措施

Steroids

Dexamethasone 6mg intravenous OD for seven to ten days

干预措施: Corticosteroid with or without colchicine (Drug)

Colchicine

Patients treated with colchicine at a dose of 0.5 mg every 12 hours for 7 to 14 days.

干预措施: Corticosteroid with or without colchicine (Drug)

结局指标

主要结局

Outcome

时间窗: March 20 to August 07, 2020

Dead or alive

次要结局

未报告次要终点

研究者

发起方
Clínica Medellín - Grupo Quirónsalud
申办方类型
Other
责任方
Principal Investigator
主要研究者

Miguel Alejandro Pinzón

Internal Medicine - Infectious Diseases Specialist

Clínica Medellín - Grupo Quirónsalud

研究点 (1)

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