Post-COVID-19 Condition: Observational Study in Vietnam
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 835
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: Day 0
According to the WHO definition
Secondary Outcomes
- 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)