Multicentric Evaluation of the Impact on Hypoxia Sensitivity of Patients With COVID-19 (CORONALTITUDE)
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|ClinicalTrials.gov Identifier: NCT05167357|
Recruitment Status : Recruiting
First Posted : December 22, 2021
Last Update Posted : December 22, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Covid19 SARS-CoV2 Infection Hypoxia, Altitude||Biological: COVID19||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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)|
|Masking Description:||All subjects, whether partaking in the COVID+ group or control group, got the same intervention. As such, the 'intervention' rather is the having undergone COVID19 or not. Involving sanitary reasons surrounding the COVID pandemic, a lack of communication concerning the COVID diagnosis between and to any party would have led to unnecessary health endangerment of concerned parties.|
|Official Title:||Multicentric Evaluation of the Impact on Hypoxia Sensitivity of Patients With COVID-19|
|Actual Study Start Date :||March 18, 2021|
|Estimated Primary Completion Date :||November 30, 2022|
|Estimated Study Completion Date :||November 30, 2022|
Experimental: COVID+ group
As the performance of the Richalet test is done by both arms, the intervention rather is the having undergone COVID19.
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.
No Intervention: Control group / COVID- group
Performance of the Richalet test is done by both arms, the control in this study here is the having stayed clear of COVID19.
- desaturation induced by hypoxia at exercise (∆SaO2) [ Time Frame: Assessment for every participant 1.5-3 years after the previous mountain altitude consultation. 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: Assessment for every participant 1.5-3 years after the previous mountain altitude consultation. 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: Assessment for every participant 1.5-3 years after the previous mountain altitude consultation. 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
- SHAI prediction score [ Time Frame: Assessment for every participant 1.5-3 years after the previous mountain altitude consultation and multiSHAI computation. Assessment over a period of time of a common mountain consultation - around half a day. ]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).
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): NCT05167357
|Contact: François LECOQ-JAMMES, Dr.||04 50 53 84 firstname.lastname@example.org|
|Institut de Formation et de Recherche en Médecine de Montagne (IFREMMONT)||Recruiting|
|Chamonix-Mont-Blanc, Auvergne-Rhône-Alpes, France, 74400|
|Sub-Investigator: Jean-Paul Richalet, Prof.|
|Sub-Investigator: Guy Duperrex, Dr.|
|Sub-Investigator: Paul Robach, PhD.|
|Principal Investigator:||François Lecoq-Jammes, Dr.||study coordinator|