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Clinical Trials/NCT04716543
NCT04716543UnknownNot Applicable

One-health Approach in Epidemiological Investigation of SARS-CoV-2 in Laos

ANRS, Emerging Infectious Diseases0 sites5,400 target enrollmentStarted: August 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
5,400
Primary Endpoint
Prevalence of SARS-CoV-2 RNA in respiratory samples collected from influenza-like illness patients from cohort study 2020-2021

Study Overview

Brief Summary

The Respiratory infection COVID-19, due to a new coronavirus, SARS-CoV2, appeared in December 2019 in several people who attended the wildlife market in Wuhan, Hubei Province, China. While COVID-19 has spread to nearly 200 countries and caused two millions infections, Lao PDR detected its first confirmed case very recently, on March 20, three months after the start of the outbreak in China. As of April 12th, 2020, Lao PDR has only recorded 18 confirmed cases, a very low number compared to other countries around the world.

However, several key factors suggest that Lao PDR could be much more affected by COVID-19 because of the following reasons: (i) The multiple and massive trans-border movements between Lao PDR and China. (ii) The similar biogeographical and socio-ecological characteristics with South-Western China. (iii) The detection of a high diversity of Betacoronavirus sequences in several species of bats in Lao PDR. (iv) The numerous markets selling high volumes of local wildlife including bats and pangolins.

LACOVISS project aim at investigating, using a ONE-HEALTH approach, this unexpected epidemiological pattern of SARS-CoV-2 in Lao PDR by bringing together an interdisciplinary team of experts in the field from IRD, the University of Caen, the Center of Infectiology Lao-Christophe Mérieux (CILM) and the National animal Health Laboratory (NAHL) in Vientiane. The study will focus on a community-based cohort of 1092 households, including 5400 study participants, followed-up between March 2015 and February 2019 for influenza-like illness investigation and causative agents detection (LACORIS project), located in the Vientiane metropolitan area. The COVID-19 progression in Lao PDR, and track SARS-CoV-2, will be followed retrospectively and prospectively, in all potential actors in SARS-CoV-2 circulation, including humans, domestic animals, and wildlife.

The LACOVISS project will undoubtedly bring new insight in SARS-Cov-2 and SARS-CoV-like circulation in Lao PDR as well as valuable information on the natural history of COVID-19, and on the modalities of the spillover into humans, which are still largely unknown.

Detailed Description

  1. INTRODUCTION

This project is mainly based on two major questions that remain unsolved. The first one is the origin of the outbreak and the events that led to the transmission of SARS-CoV-2 to humans. The second is the striking epidemiological situation in Laos, in which only a few cases have been observed despite similar biogeographical and socio-ecological characteristics shared with South-Western China.The diversity of wild fauna (notably in southern China and in South-East Asia, where bat diversity peaks to over 100 species), associated with the wide circulation of coronaviruses, especially in Laos PDR, and their evolutionary and zoonotic potential, indicate that (past or future) emergences in Laos can be expected. In addition, given the massive population movement between Laos and China, it was expected a significant spread of COVID-19 from China to Laos. In order to respond to these two main questions, the investigators formulate the following working hypotheses to address in this project.

Assumption 1: COVID-19 may massively spread to the Laos population in the near future through the arrival in the country of infected individuals.

Assumption 2: SARS-CoV-2 has been already circulating in Laos before the appearance of COVID-19 outbreak in China.

Assumption 3: SARS-CoV-2 may jump from wildlife and emerge into the Lao human population in the future Assumption 4: Some genetic closely related viruses (SARS-CoV-2-like viruses) have already circulated in Laos. 2. OBJECTIVES

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
6 Months to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Living in their respective village for 6 months or more.
  • Physically reside in the village for more than 80% of the time during the duration of the study.
  • Study subjects ≥ 6 months of age (no upper age limit).
  • Consent form signed by patient, or if under 18 years of age or patients with learning difficulty or other vulnerability with impaired ability to decide on consent, signed by parent or guardian.
  • Agrees to comply with study requirements.

Exclusion Criteria

  • Study subjects under the age of 6 months.
  • Study subjects or parents/guardians that do not accept participation.
  • Study subjects or parents/guardians who refuse to sign informed consent.

Outcomes

Primary Outcomes

Prevalence of SARS-CoV-2 RNA in respiratory samples collected from influenza-like illness patients from cohort study 2020-2021

Time Frame: Months 12

Number of participants SARS-CoV-2 positive among total number of participants tested

Secondary Outcomes

  • Prevalence of SARS-CoV-2 RNA in respiratory samples from influenza-like illness patients from cohort study between 2015 and 2019(Months 12)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

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