Covid19NCT05167357
Coronaltitude - Multicentric Evaluation of the Impact on Hypoxia Sensitivity of Patients With COVID-19
A study testing COVID19 in people with Covid19 and SARS-CoV2 Infection, run by Institut de Formation et de Recherche en Médecine de Montagne at 1 site in France.
Trial summary
In this study, the investigators will examine the extent to which having suffered coronavirus disease 2019 (COVID19) impacts one's sensibility to hypoxia by means of the 'Richalet test'. The aim of the study is to formulate recommendations for advice in altitude mountain medicine for patients having suffered COVID19. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-CoV2 Infection, Hypoxia, Altitude
- What is being tested?
- COVID19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2021to 2 Nov 2021
- Phase
- Interventional
- 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
Who may be able to join
- Subject having suffered COVID19 in the 12 months before inclusion, attested by a positive PCR, positive serology test or positive chest CT scan. (COVID+ group).
- Subject having stayed clear of COVID19 (COVID-/control group).
- Subject having been well informed and having provided written informed consent before participation.
- Subject covered by social security of some sort.
- Subject with an oxygen saturation of SpO2 > 95% in ambient air on day of Richalet test performance.
- Subject presenting with no symptoms of COVID19 (anymore) on the day of the experiment.
- Subject having already performed the Richalet hypoxia exercise test as part of the altitude mountain consultation in the years 2015 to 2019 in any of the 13 hospital centers participating at the study.
Who cannot join
- Subject with a history of respiratory, cardiovascular, neuromuscular, metabolic or renal pathologies.
- Subject with a history of psychiatric or behavioral disorder.
- Subject covered by L1121-5 to L1121-8 sections of the Public Health regulations (Code de la Santé Publique).
- Subject under guardian- or curatorship.
- Subject without social insurance.
- Subjet under the age of 18.
- Subject refusing to participate in the study.
- Subject diagnosed with an infection by a pathogen other than SARS-CoV-2.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Formation et de Recherche en Médecine de Montagne (IFREMMONT)
Chamonix, Auvergne-Rhône-Alpes, 74400
About this study
Official title: Multicentric Evaluation of the Impact on Hypoxia Sensitivity of Patients With COVID-19
In this study, the investigators will examine the extent to which having suffered coronavirus disease 2019 (COVID19) impacts one's sensibility to hypoxia by means of the 'Richalet test'. The aim of the study is to formulate recommendations for advice in altitude mountain medicine for patients having suffered COVID19. To determine any eventual changes in response to hypoxia, performances by participants having suffered COVID-19 and participants having stayed free of COVID-19 will be both compared intra-individually with previous performances (pre-COVID-19 pandemic) and between both groups of subjects. The investigators hypothesize that patients having suffered COVID19 might perform differently on the cardiopulmonary exercise test compared to before the illness. Based on recent research on COVID19 pathophysiology and -patient follow-up, it might be expected that COVID19 alters the response to hypoxia, thus influencing one's acclimatization capabilities at high altitude, albeit reversibly and/or temporarily.
Different alterations of response to hypoxia could be observed. The virus causing COVID19, the "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2), has the potential to significantly damage the nervous system and to affect cardiorespiratory functions. If SARS-CoV-2 does, similarly to MERS and SARS, induce cardiorespiratory and neurological dysfunction, then COVID19 patients may have impaired hypoxia response after infection and perform worse on the 'Richalet test' in comparison to before the illness.
Conversely, reports of high prevalence of dyspnea in patients up to 3 months after SARS-CoV-2 infection, might indicate infection-induced degenerative changes in the carotid bodies, which might lead to sensibilization of the peripheral chemoreceptors to impaired oxygenation. Possibly similar to the impact of aging and smoking on the cardiorespiratory response to hypoxia, this phenomenon of sensibilization could entail an increased hypoxic response in patients having suffered COVID-19. Accordingly, patients might perform better on the 'Richalet test' post-COVID-19 than they did before.
Read the detailed description
In this study, the focus will be on the portion of COVID-19 survivors which contemplates to travel to and (temporarily) reside in high altitude regions (>2500m). It is well known that as altitude increases, the barometric pressure falls, proportionally paralleled by a decreasing partial pressure of oxygen. At high altitude, this leads to a condition which is referred to as a hypobaric hypoxic environment. The dramatic drop in partial pressure of inspired oxygen and subsequent reduction in arterial partial pressure of oxygen implicates significant adjustments for the human body to survive at high altitude. In order to study the possible long-term effects of COVID-19 on oxygen transport physiology in these patients, the investigators will focus on the eventual cardiorespiratory and neurological consequences of SARS-CoV-2 infection and relate them to the physiological demands placed on the body by hypoxia at high altitude. This case-control study will be conducted by means of the 'Richalet Test', a hypoxia cardiorespiratory exercise test which has been validated for mountain medicine consultations to detect patients at risk of developing an inadequate response to hypoxia at high altitude. From the patients who came for consultation between 2015 and 2020, participants have been recruited by mail for the Coronaltitude study. All included participants, divided into those having suffered COVID-19 (COVID+ group) and those having stayed free of COVID-19 (control group), will retake an altitude mountain consultation. Results will be compared in between and within both groups with previous performances to determine if the response to hypoxia has changed in people having undergone COVID-19.
- Conditions
- Covid19, SARS-CoV2 Infection, Hypoxia, Altitude
- Being tested
- COVID19
- Keywords
- Hypoxia, high Altitude, Cardiorespiratory injury, Respiratory Tract Infections, Neurological injury, Neurotropism, Acclimatization, High Altitude Effects, High Altitude Illness, Cardiorespiratory Exercise Test, Covid19, SARS-CoV-2, Hypoxia sensibility, Hypoxic response, Carotid bodies, Chemosensitivity, Covid19, pathophysiology, hypoxia at exercise, hypoxic cardiac response at exercise, hypoxic ventilatory response at exercise
- Medical subject headings
- COVID-19, Altitude Sickness, Hypoxia, Respiratory Tract Infections, Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID19Biological
Also called SARS-CoV-2, Covid, severe acute respiratory syndrome coronavirus 2
Intervention in experimental group (COVID+ group) is the disease itself, compared to the control group (COVID- group). At inclusion, subjects have been asked if they have suffered COVID19 in the 12 months before inclusion, during whichever wave, attested by a positive PCR, positive serology test or positive chest CT scan.
Moreover, the Richalet test is a cardiorespiratory exercise test on an ergocycle (an electrically braked cycloergometer), whilst continuous measurement by a 12-lead ECG, a blood pressure cuff, a metabograph and an ear pulse oximeter. This, to assess cardiac response, ventilatory response and relevant metabolic parameters (CF, RR, SpO2, volume, BP). Subjects breathes through a mask connected to a gas mixer, which provides a gas mixture with 11,5% oxygen (corresponding to ambient air at an altitude of 4800m) in the hypoxia phases.
| Study group | Role | What they receive |
|---|---|---|
| COVID+ group | Experimental | As the performance of the Richalet test is done by both arms, the intervention rather is the having undergone COVID19. Receives: Biological: COVID19 |
| Control group / COVID- group | No intervention | Performance of the Richalet test is done by both arms, the control in this study here is the having stayed clear of COVID19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
desaturation induced by hypoxia at exercise (∆SaO2)
∆SaO2, HCRe and HVRe are considered to be indirect measurements of the chemosensitivity and response to hypoxia. HCRe and HVRe are calculated from the ratio of respective increased parameters (CF and RR) over the decrease in arterial oxygen saturation measured in 5 consecutive phases of the hypoxic exercise test.
Measured: Continuous measuring during the entirety of the hypoxia exercise test over a period of time of around 30 min with cornerstone measurements every 4 min.
hypoxic cardiac response at exercise (HCRe)
See description outcome 1
Measured: Continuous measuring during the entirety of the hypoxia exercise test over a period of time of around 30 min with cornerstone measurements every 4 min.
hypoxic ventilatory response at exercise (HVRe)
see description outcome 1
Measured: Continuous measuring during the entirety of the hypoxia exercise test over a period of time of around 30 min with cornerstone measurements every 4 min.
Secondary outcomes (1)
SHAI prediction score
Calculated by means of obtained results of the Richalet test combined with normalized answers to the altitude mountain consultation questionnaires. In turn, normalized SHAI scores are also compared within and in between both groups in order to evaluate the eventual impact of having suffered COVID19 one one's susceptibility to develop SHAI symptoms. Assessment after each subject has performed the Richalet test - using the by the multiSHAI study validated computation of the SHAI score to define the individual susceptibility to Severe High Altitude Illness (SHAI).
Measured: Assessment over a period of time of a common mountain consultation - around half a day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start13 Jan 2021
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- From the patients who came for consultation between 2015 and 2020, subjects have been recruited by mail for the Coronaltitude study from the 1st of March (2021) on. Subjects have been asked if they have suffered COVID19 in the 12 months before inclusion, during whichever wave, attested by a positive PCR, positive serology test or positive chest CT scan. Both patients answering positively and those answering negatively on the latter question have been included in the study. All included subjects, divided into those having suffered COVID19 (COVID+ group) and those having stayed free of COVID19 (control group), will retake an altitude mountain consultation.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Formation et de Recherche en Médecine de Montagne
- Sponsor type
- University, hospital or other
- Collaborators
- University of Paris 13, Ecole Nationale des Sports de Montagne
- Responsible party
- Principal investigator, Lecoq James François, Institut de Formation et de Recherche en Médecine de Montagne
- Investigators
- François Lecoq-Jammes, Dr., Principal investigator, study coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167357
- Sponsor's protocol ID
- CORONALTITUDE2021
- Status last verified
- Mar 2024
- First submitted
- 5 Sep 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Richalet JP, Pillard F, LE Moal D, Riviere D, Oriol P, Poussel M, Chenuel B, Doutreleau S, Verges S, Demanez S, Vergnion M, Boulet JM, Douard H, Dupre M, Mesland O, Remetter R, Lonsdorfer-Wolf E, Frey A, Vilcoq L, Nedelec Jaffuel A, Debeaumont D, Duperrex G, Lecoq F, Hedon C, Hayot M, Giardini G, Lhuissier FJ. Validation of a Score for the Detection of Subjects with High Risk for Severe High-Altitude Illness. Med Sci Sports Exerc. 2021 Jun 1;53(6):1294-1302. doi: 10.1249/MSS.0000000000002586.
PubMed 33433150Richalet JP, Canoui-Poitrine F. Pro: hypoxic cardiopulmonary exercise testing identifies subjects at risk for severe high altitude illnesses. High Alt Med Biol. 2014 Sep;15(3):315-7. doi: 10.1089/ham.2014.1032. No abstract available.
PubMed 25251925Cao Y, Liu X, Xiong L, Cai K. Imaging and clinical features of patients with 2019 novel coronavirus SARS-CoV-2: A systematic review and meta-analysis. J Med Virol. 2020 Sep;92(9):1449-1459. doi: 10.1002/jmv.25822. Epub 2020 Apr 10.
PubMed 32242947Wiersinga WJ, Rhodes A, Cheng AC, Peacock SJ, Prescott HC. Pathophysiology, Transmission, Diagnosis, and Treatment of Coronavirus Disease 2019 (COVID-19): A Review. JAMA. 2020 Aug 25;324(8):782-793. doi: 10.1001/jama.2020.12839.
PubMed 32648899Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
PubMed 33428867Higgins V, Sohaei D, Diamandis EP, Prassas I. COVID-19: from an acute to chronic disease? Potential long-term health consequences. Crit Rev Clin Lab Sci. 2021 Aug;58(5):297-310. doi: 10.1080/10408363.2020.1860895. Epub 2020 Dec 21.
PubMed 33347790Luks AM, Grissom CK. Return to High Altitude After Recovery from Coronavirus Disease 2019. High Alt Med Biol. 2021 Jun;22(2):119-127. doi: 10.1089/ham.2021.0049. Epub 2021 May 11.
PubMed 33978479Canoui-Poitrine F, Veerabudun K, Larmignat P, Letournel M, Bastuji-Garin S, Richalet JP. Risk prediction score for severe high altitude illness: a cohort study. PLoS One. 2014 Jul 28;9(7):e100642. doi: 10.1371/journal.pone.0100642. eCollection 2014.
PubMed 25068815Coustet B, Lhuissier FJ, Vincent R, Richalet JP. Electrocardiographic changes during exercise in acute hypoxia and susceptibility to severe high-altitude illnesses. Circulation. 2015 Mar 3;131(9):786-94. doi: 10.1161/CIRCULATIONAHA.114.013144. Epub 2015 Jan 5.
PubMed 25561515Richalet JP, Larmignat P, Poitrine E, Letournel M, Canoui-Poitrine F. Physiological risk factors for severe high-altitude illness: a prospective cohort study. Am J Respir Crit Care Med. 2012 Jan 15;185(2):192-8. doi: 10.1164/rccm.201108-1396OC. Epub 2011 Oct 27.
PubMed 22071330Algahtani H, Subahi A, Shirah B. Neurological Complications of Middle East Respiratory Syndrome Coronavirus: A Report of Two Cases and Review of the Literature. Case Rep Neurol Med. 2016;2016:3502683. doi: 10.1155/2016/3502683. Epub 2016 Apr 28.
PubMed 27239356Desforges M, Le Coupanec A, Dubeau P, Bourgouin A, Lajoie L, Dube M, Talbot PJ. Human Coronaviruses and Other Respiratory Viruses: Underestimated Opportunistic Pathogens of the Central Nervous System? Viruses. 2019 Dec 20;12(1):14. doi: 10.3390/v12010014.
PubMed 31861926Li YC, Bai WZ, Hashikawa T. The neuroinvasive potential of SARS-CoV2 may play a role in the respiratory failure of COVID-19 patients. J Med Virol. 2020 Jun;92(6):552-555. doi: 10.1002/jmv.25728. Epub 2020 Mar 11.
PubMed 32104915Montalvan V, Lee J, Bueso T, De Toledo J, Rivas K. Neurological manifestations of COVID-19 and other coronavirus infections: A systematic review. Clin Neurol Neurosurg. 2020 Jul;194:105921. doi: 10.1016/j.clineuro.2020.105921. Epub 2020 May 15.
PubMed 32422545Ellul MA, Benjamin L, Singh B, Lant S, Michael BD, Easton A, Kneen R, Defres S, Sejvar J, Solomon T. Neurological associations of COVID-19. Lancet Neurol. 2020 Sep;19(9):767-783. doi: 10.1016/S1474-4422(20)30221-0. Epub 2020 Jul 2.
PubMed 32622375
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Evaluation of the Impact on Hypoxia Sensitivity of Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05167357
- Acronym / sponsor ID
- CORONALTITUDE2021
- Conditions
- Covid19, SARS-CoV2 Infection, Hypoxia, Altitude
- Keywords
- Hypoxia, high Altitude, Cardiorespiratory injury, Respiratory Tract Infections, Neurological injury, Neurotropism, Acclimatization, High Altitude Effects, High Altitude Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Institut de Formation et de Recherche en Médecine de MontagneUniversity, hospital or other
- Collaborators
- University of Paris 13, Ecole Nationale des Sports de Montagne
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 22 Dec 2021 (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.
In this study, the investigators will examine the extent to which having suffered coronavirus disease 2019 (COVID19) impacts one's sensibility to hypoxia by means of the 'Richalet test'. The aim of the study is to formulate recommendations for advice in altitude mountain medicine for patients having suffered COVID19. To determine any eventual changes in response to hypoxia, performances by participants having suffered COVID-19 and participants having stayed free of COVID-19 will be both compared intra-individually with previous performances (pre-COVID-19 pandemic) and between both groups of subjects. The investigators hypothesize that patients having suffered COVID19 might perform differently on the cardiopulmonary exercise test compared to before the illness. Based on recent research on COVID19 pathophysiology and -patient follow-up, it might be expected that COVID19 alters the response to hypoxia, thus influencing one's acclimatization capabilities at high altitude, albeit reversibly and/or temporarily.
Different alterations of response to hypoxia could be observed. The virus causing COVID19, the "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2), has the potential to significantly damage the nervous system and to affect cardiorespiratory functions. If SARS-CoV-2 does, similarly to MERS and SARS, induce cardiorespiratory and neurological dysfunction, then COVID19 patients may have impaired hypoxia response after infection and perform worse on the 'Richalet test' in comparison to before the illness.
Conversely, reports of high prevalence of dyspnea in patients up to 3 months after SARS-CoV-2 infection, might indicate infection-induced degenerative changes in the carotid bodies, which might lead to sensibilization of the peripheral chemoreceptors to impaired oxygenation. Possibly similar to the impact of aging and smoking on the cardiorespiratory response to hypoxia, this phenomenon of sensibilization could entail an increased hypoxic response in patients having suffered COVID-19. Accordingly, patients might perform better on the 'Richalet test' post-COVID-19 than they did before.
Detailed description
In this study, the focus will be on the portion of COVID-19 survivors which contemplates to travel to and (temporarily) reside in high altitude regions (>2500m). It is well known that as altitude increases, the barometric pressure falls, proportionally paralleled by a decreasing partial pressure of oxygen. At high altitude, this leads to a condition which is referred to as a hypobaric hypoxic environment. The dramatic drop in partial pressure of inspired oxygen and subsequent reduction in arterial partial pressure of oxygen implicates significant adjustments for the human body to survive at high altitude. In order to study the possible long-term effects of COVID-19 on oxygen transport physiology in these patients, the investigators will focus on the eventual cardiorespiratory and neurological consequences of SARS-CoV-2 infection and relate them to the physiological demands placed on the body by hypoxia at high altitude. This case-control study will be conducted by means of the 'Richalet Test', a hypoxia cardiorespiratory exercise test which has been validated for mountain medicine consultations to detect patients at risk of developing an inadequate response to hypoxia at high altitude. From the patients who came for consultation between 2015 and 2020, participants have been recruited by mail for the Coronaltitude study. All included participants, divided into those having suffered COVID-19 (COVID+ group) and those having stayed free of COVID-19 (control group), will retake an altitude mountain consultation. Results will be compared in between and within both groups with previous performances to determine if the response to hypoxia has changed in people having undergone COVID-19.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- From the patients who came for consultation between 2015 and 2020, subjects have been recruited by mail for the Coronaltitude study from the 1st of March (2021) on. Subjects have been asked if they have suffered COVID19 in the 12 months before inclusion, during whichever wave, attested by a positive PCR, positive serology test or positive chest CT scan. Both patients answering positively and those answering negatively on the latter question have been included in the study. All included subjects, divided into those having suffered COVID19 (COVID+ group) and those having stayed free of COVID19 (control group), will retake an altitude mountain consultation.
| Arm | Type | Receives |
|---|---|---|
| COVID+ group | Experimental | Biological: COVID19As the performance of the Richalet test is done by both arms, the intervention rather is the having undergone COVID19. |
| Control group / COVID- group | No intervention | –Performance of the Richalet test is done by both arms, the control in this study here is the having stayed clear of COVID19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject having suffered COVID19 in the 12 months before inclusion, attested by a positive PCR, positive serology test or positive chest CT scan. (COVID+ group).
- Subject having stayed clear of COVID19 (COVID-/control group).
- Subject having been well informed and having provided written informed consent before participation.
- Subject covered by social security of some sort.
- Subject with an oxygen saturation of SpO2 > 95% in ambient air on day of Richalet test performance.
Key exclusion criteria (8 listed)
- Subject with a history of respiratory, cardiovascular, neuromuscular, metabolic or renal pathologies.
- Subject with a history of psychiatric or behavioral disorder.
- Subject covered by L1121-5 to L1121-8 sections of the Public Health regulations (Code de la Santé Publique).
- Subject under guardian- or curatorship.
- Subject without social insurance.
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 |
|---|---|---|
| COVID19Also: SARS-CoV-2, Covid, severe acute respiratory syndrome coronavirus 2Intervention in experimental group (COVID+ group) is the disease itself, compared to the control group (COVID- group). At inclusion, subjects have been asked if they have suffered COVID19 in the 12 months before inclusion, during whichever wave, attested by a positive PCR, positive serology test or positive chest CT scan. Moreover, the Richalet test is a cardiorespiratory exercise test on an ergocycle (an electrically braked cycloergometer), whilst continuous measurement by a 12-lead ECG, a blood pressure cuff, a metabograph and an ear pulse oximeter. This, to assess cardiac response, ventilatory response and relevant metabolic parameters (CF, RR, SpO2, volume, BP). Subjects breathes through a mask connected to a gas mixer, which provides a gas mixture with 11,5% oxygen (corresponding to ambient air at an altitude of 4800m) in the hypoxia phases. | Biological | COVID+ group |
Primary outcome
desaturation induced by hypoxia at exercise (∆SaO2)
Time frame: Continuous measuring during the entirety of the hypoxia exercise test over a period of time of around 30 min with cornerstone measurements every 4 min.
∆SaO2, HCRe and HVRe are considered to be indirect measurements of the chemosensitivity and response to hypoxia. HCRe and HVRe are calculated from the ratio of respective increased parameters (CF and RR) over the decrease in arterial oxygen saturation measured in 5 consecutive phases of the hypoxic exercise test.
hypoxic cardiac response at exercise (HCRe)
Time frame: Continuous measuring during the entirety of the hypoxia exercise test over a period of time of around 30 min with cornerstone measurements every 4 min.
See description outcome 1
hypoxic ventilatory response at exercise (HVRe)
Time frame: Continuous measuring during the entirety of the hypoxia exercise test over a period of time of around 30 min with cornerstone measurements every 4 min.
see description outcome 1
1 secondary outcome
SHAI prediction score
Time frame: Assessment over a period of time of a common mountain consultation - around half a day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 33433150Richalet JP, Pillard F, LE Moal D, Riviere D, Oriol P, Poussel M, Chenuel B, Doutreleau S, Verges S, Demanez S, Vergnion M, Boulet JM, Douard H, Dupre M, Mesland O, Remetter R, Lonsdorfer-Wolf E, Frey A, Vilcoq L, Nedelec Jaffuel A, Debeaumont D, Duperrex G, Lecoq F, Hedon C, Hayot M, Giardini G, Lhuissier FJ. Validation of a Score for the Detection of Subjects with High Risk for Severe High-Altitude Illness. Med Sci Sports Exerc. 2021 Jun 1;53(6):1294-1302. doi: 10.1249/MSS.0000000000002586.
- Background: PubMed 25251925Richalet JP, Canoui-Poitrine F. Pro: hypoxic cardiopulmonary exercise testing identifies subjects at risk for severe high altitude illnesses. High Alt Med Biol. 2014 Sep;15(3):315-7. doi: 10.1089/ham.2014.1032. No abstract available.
- Background: PubMed 32242947Cao Y, Liu X, Xiong L, Cai K. Imaging and clinical features of patients with 2019 novel coronavirus SARS-CoV-2: A systematic review and meta-analysis. J Med Virol. 2020 Sep;92(9):1449-1459. doi: 10.1002/jmv.25822. Epub 2020 Apr 10.
- Background: PubMed 32648899Wiersinga WJ, Rhodes A, Cheng AC, Peacock SJ, Prescott HC. Pathophysiology, Transmission, Diagnosis, and Treatment of Coronavirus Disease 2019 (COVID-19): A Review. JAMA. 2020 Aug 25;324(8):782-793. doi: 10.1001/jama.2020.12839.
- Background: PubMed 33428867Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
- Background: PubMed 33347790Higgins V, Sohaei D, Diamandis EP, Prassas I. COVID-19: from an acute to chronic disease? Potential long-term health consequences. Crit Rev Clin Lab Sci. 2021 Aug;58(5):297-310. doi: 10.1080/10408363.2020.1860895. Epub 2020 Dec 21.
- Background: PubMed 33978479Luks AM, Grissom CK. Return to High Altitude After Recovery from Coronavirus Disease 2019. High Alt Med Biol. 2021 Jun;22(2):119-127. doi: 10.1089/ham.2021.0049. Epub 2021 May 11.
- Background: PubMed 25068815Canoui-Poitrine F, Veerabudun K, Larmignat P, Letournel M, Bastuji-Garin S, Richalet JP. Risk prediction score for severe high altitude illness: a cohort study. PLoS One. 2014 Jul 28;9(7):e100642. doi: 10.1371/journal.pone.0100642. eCollection 2014.
- Background: PubMed 25561515Coustet B, Lhuissier FJ, Vincent R, Richalet JP. Electrocardiographic changes during exercise in acute hypoxia and susceptibility to severe high-altitude illnesses. Circulation. 2015 Mar 3;131(9):786-94. doi: 10.1161/CIRCULATIONAHA.114.013144. Epub 2015 Jan 5.
- Background: PubMed 22071330Richalet JP, Larmignat P, Poitrine E, Letournel M, Canoui-Poitrine F. Physiological risk factors for severe high-altitude illness: a prospective cohort study. Am J Respir Crit Care Med. 2012 Jan 15;185(2):192-8. doi: 10.1164/rccm.201108-1396OC. Epub 2011 Oct 27.
- Background: PubMed 27239356Algahtani H, Subahi A, Shirah B. Neurological Complications of Middle East Respiratory Syndrome Coronavirus: A Report of Two Cases and Review of the Literature. Case Rep Neurol Med. 2016;2016:3502683. doi: 10.1155/2016/3502683. Epub 2016 Apr 28.
- Background: PubMed 31861926Desforges M, Le Coupanec A, Dubeau P, Bourgouin A, Lajoie L, Dube M, Talbot PJ. Human Coronaviruses and Other Respiratory Viruses: Underestimated Opportunistic Pathogens of the Central Nervous System? Viruses. 2019 Dec 20;12(1):14. doi: 10.3390/v12010014.
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Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
François Lecoq-Jammes, Dr. principal investigator
study coordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID19 in people with Covid19 and SARS-CoV2 Infection, run by Institut de Formation et de Recherche en Médecine de Montagne at 1 site in France.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 12 Mar 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
desaturation induced by hypoxia at exercise (∆SaO2) (time frame: Continuous measuring during the entirety of the hypoxia exercise test over a period of time of around 30 min with cornerstone measurements every 4 min.). The study lists 3 primary outcomes in all. 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 NCT05167357, which also lists 37 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 12 Mar 2024.