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Epidemiological Investigation of COVID-19 in Laos Using a One-Health Approach in Human and Animals (LACOVISS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04716543
Recruitment Status : Not yet recruiting
First Posted : January 20, 2021
Last Update Posted : July 1, 2021
Sponsor:
Collaborators:
Institut de Recherche pour le Developpement
Centre d'Infectiologie Charles Mérieux
University Hospital, Caen
Department of livestock and fisheries National animal health laboratory, Vientiane, Laos
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

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.


Condition or disease Intervention/treatment
Influenza -Like Illness Covid19 Diagnostic Test: ILI and COVID-19 detection

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Study Type : Observational
Estimated Enrollment : 5400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: One-health Approach in Epidemiological Investigation of SARS-CoV-2 in Laos
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ILI Investigation
The suspected ILI cases will be first identified using the WHO clinical case definition of ILI and Covid 19 as either with:Acute onset of fever (> 37.5˚C axillary temperature or > 38˚C tympanic temperature) AND cough; OR Acute onset of ANY ONE OR MORE of the following signs or symptoms: Fever, cough, general weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnoea, anosmia (loss of smell) or ageusia (loss of taste); with symptoms with onset within the last 10 days.
Diagnostic Test: ILI and COVID-19 detection

All participants presenting with ILI symptoms will have non-invasive exam for SARS-CoV-2 detection (nasal, throat, swab, saliva) and a questionnaire.

All family members more than 6 months living with SARS-CoV-2 positive individuals will have will have non-invasive exam for SARS-CoV-2 detection (nasal, throat, swab, saliva) and a questionnaire.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Prevalence of SARS-CoV-2 RNA in respiratory samples from influenza-like illness patients from cohort study between 2015 and 2019 [ Time Frame: Months 12 ]
    Number of respiratory samples positive for SARS-CoV-2 over the total number of respiratory samples from the 2015-2019 cohort


Other Outcome Measures:
  1. Prevalence of SARS-CoV-2 RNA in respiratory samples from intrafamilial contacts of influenza-like illness patients (2020-2021) [ Time Frame: Months 12 ]
    Number of SARS-CoV-2 positive samples among the total number of samples collected from participants living within the family nucleus of influenza-like illness patients

  2. Prevalence of SARS-CoV-2 IgG among 1000 individuals randomly selected from the 2020-2121 study cohort. IgG will be assayed in saliva samples [ Time Frame: Months 12 ]
    Number of participants IgG positive over a thousand, randomly selected, participants tested.

  3. Prevalence of SARS-CoV-2 RNA in respiratory and faecal samples collected from companion animals living with influenza-like illness patients [ Time Frame: Months 12 ]
    Number of pet animals positive for SARS-CoV-2 over the total number of pets tested


Biospecimen Retention:   Samples Without DNA
Nasal and saliva swabs


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will cover 1092 households, including 5400 study participants living in 25 villages within the administrative boundaries of the Vientiane metropolitan area.
Criteria

All permanent residents of the household who meet the inclusion criteria of > 6 months old and living in their respective village for at least 6 months will be eligible to participate. All people from the anterior LACORIS study (2015-2019), will be invited to participate to the study.

Over a year, active case finding for influenza-like illness (ILI) will be conducted among the cohort by staff at CILM. The suspected ILI cases will be first identified using the WHO clinical case definition of ILI and Covid 19 as either with:

Acute onset of fever (> 37.5˚C axillary temperature or > 38˚C tympanic temperature) AND cough; OR Acute onset of ANY ONE OR MORE of the following signs or symptoms: Fever, cough, general weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnoea, anosmia (loss of smell) or ageusia (loss of taste).

with symptoms with onset within the last 10 days.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716543


Contacts
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Contact: Eric M LEROY, DVM, PhD +33 467416107 eric.leroy@ird.fr
Contact: Sabrina LOCATELLI, PhD +33 680596357 sabrina.locatelli@ird.fr

Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
Institut de Recherche pour le Developpement
Centre d'Infectiologie Charles Mérieux
University Hospital, Caen
Department of livestock and fisheries National animal health laboratory, Vientiane, Laos
Investigators
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Principal Investigator: Phimpha PABORIBOUNE, MD, PhD Centre d'Infectiologie Lao-Christophe Mérieux
Publications:

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Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT04716543    
Other Study ID Numbers: ANRS COV20 LACOVISS
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: July 1, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ANRS, Emerging Infectious Diseases:
SARS-CoV-2
Lao PDR
One Health
virus
coronavirus
reservoir
animal
antibody
serology
PCR
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases