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临床试验/NCT06022211
NCT06022211尚未招募不适用

Post-COVID-19 Condition: Observational Study in Vietnam

ANRS, Emerging Infectious Diseases0 个研究点目标入组 835 人开始时间: 2023年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
835
主要终点
The primary endpoint is the proportion of participants who present a post-COVID-19 condition in adult patients with confirmed mild, moderate, and severe COVID-19 in Hai Phong, Vietnam.

研究概览

简要总结

The primary objective of this study is to estimate the prevalence of the post-COVID-19 condition in confirmed mild, moderate, and severe COVID-19 adult patients in Hai Phong, Vietnam.

详细描述

It is a cross-sectional study implemented in Hai Phong (Vietnam) by the Infectious and Tropical Diseases Department of Viet Tiep 2 hospital and the Department of Public Health of the Hai Phong University of Medicine and Pharmacy (HPMU).

The aim is to enroll moderate and severe COVID-19 patients from the 2 following provincial hospitals, Viet Tiep hospital and Kien An hospital, and mild COVID-19 patients from the community level in Hai Phong to assess the burden of post-COVID-19 condition in each patient group (mild, moderate or severe acute COVID-19).

835 participants are aimed to be interviewed through phone calls: 196 participants with mild disease, 289 participants with moderate disease, and 350 participants with severe disease. In case of suspected post-COVID-19 condition, the participant will be proposed to come to Viet Tiep 2 hospital for a study visit i) to confirm the post-COVID-19 condition, ii) to describe symptoms, iii) to evaluate the functional limitations related to the post-COVID-19 condition, and iv) to assess the determinants of the post-COVID-19 condition in patients with mild, moderate, and severe acute COVID-19.

研究设计

研究类型
Observational
观察模型
Other
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

  • Adults aged 18 years or more;
  • With a history of documented COVID-19 as confirmed by either a positive SARS-CoV-2 RT-PCR or antigenic test, 3-12 months before inclusion;
  • Hospitalised in Viet Tiep 2 hospital or Kien An hospital (tertiary care hospitals) with moderate or severe COVID-19 or registered in provincial CDC health system for mild COVID-19;
  • Accepting to participate in the study;

排除标准

  • Not able to understand or answer a quick phone questionnaire;
  • Individuals who refuse or cannot come to Viet Tiep 2 hospital in case of the suspected post-COVID-19 condition.

结局指标

主要结局

The primary endpoint is the proportion of participants who present a post-COVID-19 condition in adult patients with confirmed mild, moderate, and severe COVID-19 in Hai Phong, Vietnam.

时间窗: Day 0

According to the WHO definition

次要结局

  • Functional limitations among participants with the post-COVID-19 condition.(Day 0)
  • Factors related to occurrence of post-COVID-19 condition in adults after mild, moderate, and severe acute COVID-19.(Day 0)
  • Type and frequency of symptoms of the post-COVID-19 condition.(Day 0)

研究者

申办方类型
Other Gov
责任方
Sponsor

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