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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04604249
Other study ID # RINCOVID
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 26, 2020
Est. completion date December 31, 2021

Study information

Verified date February 2021
Source Centre d'Expertise sur l'Altitude EXALT
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date December 31, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18 years. Exclusion Criteria: - Age < 18 years. - Inability to give informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
SARS-CoV-2 rapid diagnostic test (COVID-PRESTO® IgM/IgG, AAZ, Boulogne-Billancourt, France)
Presence of specific SARS-CoV-2 antibodies (IgM or IgG).

Locations

Country Name City State
Peru La Rinconada Puno

Sponsors (1)

Lead Sponsor Collaborator
Centre d'Expertise sur l'Altitude EXALT

Country where clinical trial is conducted

Peru, 

References & Publications (6)

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 — View Citation

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. — View Citation

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. — View Citation

Seclén 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 1. Prevalence of seroconversion for SARS-CoV-2. Through study completion, an average of 1 week
Secondary 2. Occupational and environmental exposures associated with SARS-CoV-2 seroconversion. Through study completion, an average of 1 week
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