Post-COVID-19 Condition: Observational Study in Vietnam

Sponsor
ANRS, Emerging Infectious Diseases (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06022211
Collaborator
(none)
835
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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
    Anticipated Enrollment :
    835 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Post-COVID-19 Condition: Observational Study in Vietnam
    Anticipated Study Start Date :
    Dec 1, 2023
    Anticipated Primary Completion Date :
    May 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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. [Day 0]

      According to the WHO definition

    Secondary Outcome Measures

    1. Type and frequency of symptoms of the post-COVID-19 condition. [Day 0]

    2. Functional limitations among participants with the post-COVID-19 condition. [Day 0]

    3. Factors related to occurrence of post-COVID-19 condition in adults after mild, moderate, and severe acute COVID-19. [Day 0]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • ANRS, Emerging Infectious Diseases

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ANRS, Emerging Infectious Diseases
    ClinicalTrials.gov Identifier:
    NCT06022211
    Other Study ID Numbers:
    • ANRS 0268s POSTCOVIET
    First Posted:
    Sep 1, 2023
    Last Update Posted:
    Sep 1, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 1, 2023