Covid19RINCOVIDNCT04604249
Prevalence of COVID-19 in High Altitude : Insights From the Highest City of the World
An observational study of Covid19 and High Altitude, run by Centre d'Expertise sur l'Altitude EXALT at 1 site in Peru.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, High Altitude
- What is being tested?
- SARS-CoV-2 rapid diagnostic test (COVID-PRESTO® IgM/IgG, AAZ, Boulogne-Billancourt, France)
- How many people
- 200 participants
- Where
- 1 sitePeru
- Study dates
- 26 Oct 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inhabitants of La Rinconda, coming to a medical consultation connected to a scientific research project (Expedition5300).
Who may be able to join
- Age > 18 years.
Who cannot join
- Age < 18 years.
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of COVID-19 and Risk Factors Associated With Seroconversion in La Rinconada, the Highest City of the World - 5,100 m
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.
- Conditions
- Covid19, High Altitude
- Being tested
- SARS-CoV-2 rapid diagnostic test (COVID-PRESTO® IgM/IgG, AAZ, Boulogne-Billancourt, France)
- Keywords
- Prevalence, Covid-19, SARS-CoV-2, Hight altitude
- Medical subject headings
- COVID-19, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Prevalence of seroconversion for SARS-CoV-2.
Measured: Through study completion, an average of 1 week
Secondary outcomes (1)
2. Occupational and environmental exposures associated with SARS-CoV-2 seroconversion.
Measured: Through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start26 Oct 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Expertise sur l'Altitude EXALT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604249
- Sponsor's protocol ID
- RINCOVID
- Acronym
- RINCOVID
- Status last verified
- Feb 2021
- First submitted
- 25 Oct 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33054403Seclen 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.
PubMed 32971150Segovia-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.
PubMed 32679369Woolcott 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.
PubMed 32815745Intimayta-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.
PubMed 32803989Arias-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.
PubMed 32333993Champigneulle 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.
PubMed 34197184
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of COVID-19 and Risk Factors Associated With Seroconversion in La Rinconada, the Highest City of the World - 5,100 m
- ClinicalTrials.gov ID
- NCT04604249
- Acronym / sponsor ID
- RINCOVID / RINCOVID
- Conditions
- Covid19, High Altitude
- Keywords
- Prevalence, Covid-19, SARS-CoV-2, Hight altitude
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre d'Expertise sur l'Altitude EXALTUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inhabitants of La Rinconda, coming to a medical consultation connected to a scientific research project (Expedition5300).
Key inclusion criteria (1 listed)
- Age > 18 years.
Key exclusion criteria (2 listed)
- Age < 18 years.
- Inability to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-CoV-2 rapid diagnostic test (COVID-PRESTO® IgM/IgG, AAZ, Boulogne-Billancourt, France)Presence of specific SARS-CoV-2 antibodies (IgM or IgG). | Diagnostic test | – |
Primary outcome
1. Prevalence of seroconversion for SARS-CoV-2.
Time frame: Through study completion, an average of 1 week
1 secondary outcome
2. Occupational and environmental exposures associated with SARS-CoV-2 seroconversion.
Time frame: Through study completion, an average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Results publication: PubMed 33054403Castagnetto 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.
- Results publication: PubMed 32971150Seclen 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.
- Results publication: PubMed 32679369Segovia-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.
- Results publication: PubMed 32815745Woolcott 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.
- Results publication: PubMed 32803989Intimayta-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.
- Results publication: PubMed 32333993Arias-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.
- Derived from this study: PubMed 34197184Champigneulle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and High Altitude, run by Centre d'Expertise sur l'Altitude EXALT at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Prevalence of seroconversion for SARS-CoV-2. (time frame: Through study completion, an average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04604249, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.