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Multicentric Evaluation of the Impact on Hypoxia Sensitivity of Patients With COVID-19 (CORONALTITUDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05167357
Recruitment Status : Recruiting
First Posted : December 22, 2021
Last Update Posted : December 22, 2021
Sponsor:
Collaborators:
University of Paris 13
Ecole Nationale des Sports de Montagne
Information provided by (Responsible Party):
Lecoq James François, Institut de Formation et de Recherche en Médecine de Montagne

Study Description
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Brief 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. 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

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
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.
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: COVID+ group
As the performance of the Richalet test is done by both arms, the intervention rather is the having undergone COVID19.
 Biological: 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.

Other Names:
  • SARS-CoV-2
  • Covid
  • severe acute respiratory syndrome coronavirus 2
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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


Secondary Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: François LECOQ-JAMMES, Dr. 04 50 53 84 35 f.lecoq1@gmail.com

Locations
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France
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.         
Sponsors and Collaborators
Institut de Formation et de Recherche en Médecine de Montagne
University of Paris 13
Ecole Nationale des Sports de Montagne
Investigators
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Principal Investigator: François Lecoq-Jammes, Dr. study coordinator
More Information
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Publications:

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Responsible Party: Lecoq James François, Medical Doctor, PhD. Chef de pôle urgence et médecine de montagne, Institut de Formation et de Recherche en Médecine de Montagne
ClinicalTrials.gov Identifier: NCT05167357    
Other Study ID Numbers: CORONALTITUDE2021
First Posted: December 22, 2021    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lecoq James François, Institut de Formation et de Recherche en Médecine de Montagne:
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
Additional relevant MeSH terms:
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COVID-19
Altitude Sickness
Hypoxia
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Respiration Disorders