NCT04604249

Brief Summary

Since the beginning of 2020, SARS-CoV-2 outbreak spread over the world, conducting in a pandemic state declared by the world health organization in March 2020. Conflicting data have been yet published regarding to the incidence rate of COVID-19 infection in altitude. Mainly based on analysis from national Peru database, some authors argued that COVID-19 disease, as well as case fatality rate was less frequent in altitude. However, epidemiological data are lacking regarding to the prevalence of COVID-19 in altitude, and more specially in high altitude. Aim of this cross-sectional study is to assess the prevalence of seroconversion for the SARS-CoV-2 in the population of La Rinconada, a mining town at 5,100 m, the highest city in the world.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

October 26, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

October 25, 2020

Last Update Submit

February 3, 2021

Conditions

Covid19High Altitude

Keywords

PrevalenceCovid-19SARS-CoV-2Hight altitude

Outcome Measures

Primary Outcomes (1)

  • 1. Prevalence of seroconversion for SARS-CoV-2.

    Through study completion, an average of 1 week

Secondary Outcomes (1)

  • 2. Occupational and environmental exposures associated with SARS-CoV-2 seroconversion.

    Through study completion, an average of 1 week

Interventions

SARS-CoV-2 rapid diagnostic test (COVID-PRESTO® IgM/IgG, AAZ, Boulogne-Billancourt, France)DIAGNOSTIC_TEST

Presence of specific SARS-CoV-2 antibodies (IgM or IgG).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inhabitants of La Rinconda, coming to a medical consultation connected to a scientific research project (Expedition5300).

You may qualify if:

  • \- Age \> 18 years.

You may not qualify if:

  • Age \< 18 years.
  • Inability to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Rinconada

Puno, Peru

Location

Related Publications (7)

  • Castagnetto JM, Segovia-Juarez J, Gonzales GF. Letter to the Editor: COVID-19 Infections Do Not Change with Increasing Altitudes from 1,000 to 4,700 m. High Alt Med Biol. 2020 Dec;21(4):428-430. doi: 10.1089/ham.2020.0173. Epub 2020 Oct 13. No abstract available.

    PMID: 33054403RESULT

  • Seclen SN, Nunez-Robles E, Yovera-Aldana M, Arias-Chumpitaz A. Incidence of COVID-19 infection and prevalence of diabetes, obesity and hypertension according to altitude in Peruvian population. Diabetes Res Clin Pract. 2020 Nov;169:108463. doi: 10.1016/j.diabres.2020.108463. Epub 2020 Sep 22.

    PMID: 32971150RESULT

  • Segovia-Juarez J, Castagnetto JM, Gonzales GF. High altitude reduces infection rate of COVID-19 but not case-fatality rate. Respir Physiol Neurobiol. 2020 Oct;281:103494. doi: 10.1016/j.resp.2020.103494. Epub 2020 Jul 15.

    PMID: 32679369RESULT

  • Woolcott OO, Bergman RN. Mortality Attributed to COVID-19 in High-Altitude Populations. High Alt Med Biol. 2020 Dec;21(4):409-416. doi: 10.1089/ham.2020.0098. Epub 2020 Aug 17.

    PMID: 32815745RESULT

  • Intimayta-Escalante C, Rojas-Bolivar D, Hancco I. Letter to the Editor: Influence of Altitude on the Prevalence and Case Fatality Rate of COVID-19 in Peru. High Alt Med Biol. 2020 Dec;21(4):426-427. doi: 10.1089/ham.2020.0133. Epub 2020 Aug 14. No abstract available.

    PMID: 32803989RESULT

  • Arias-Reyes C, Zubieta-DeUrioste N, Poma-Machicao L, Aliaga-Raduan F, Carvajal-Rodriguez F, Dutschmann M, Schneider-Gasser EM, Zubieta-Calleja G, Soliz J. Does the pathogenesis of SARS-CoV-2 virus decrease at high-altitude? Respir Physiol Neurobiol. 2020 Jun;277:103443. doi: 10.1016/j.resp.2020.103443. Epub 2020 Apr 22.

    PMID: 32333993RESULT

  • Champigneulle B, Hancco I, Renan R, Doutreleau S, Stauffer E, Pichon A, Brugniaux JV, Pere H, Bouzat P, Veyer D, Verges S. High-Altitude Environment and COVID-19: SARS-CoV-2 Seropositivity in the Highest City in the World. High Alt Med Biol. 2024 Sep;25(3):218-222. doi: 10.1089/ham.2021.0020. Epub 2021 Jul 1.

    PMID: 34197184DERIVED

MeSH Terms

Conditions

COVID-19Altitude Sickness

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2020

First Posted

October 27, 2020

Study Start

October 26, 2020

Primary Completion

November 30, 2021

Study Completion

December 31, 2021

Last Updated

February 4, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

PE(1)