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COVID-19 Infection: Exploration of Respiratory Control Center Abnormalities (CRC-COVID)

Primary Purpose

Covid19, Neurological Complication

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
hypoxia : 14.3 and 12.7% FIO2, hypercapnia 7% CO2, inspiratory mechanical constraint
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Covid19 focused on measuring SARS-CoV-2, COVID-19, dyspnea, hypoxic stimulus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • - adult (≥ 18 years old, unprotected);
  • for COVID-19 + patients: COVID-19 + diagnosis; with quantitative or qualitative anomalies in taste and smell; first symptoms appeared in less than 21 days
  • for healthy subjects: have never presented any sign of COVID ; confirmed by recent negative serology
  • understanding French;
  • affiliated to social security;
  • having a BMI between 20 and 30;
  • preferably non-smokers and in the event of recruitment difficulties, smokers but with smoking <5 packs - year
  • signature of the informed consent form

Exclusion Criteria:

  • respiratory signs or symptoms (rhinitis, cough, shortness of breath at rest);
  • temperature above 37.5 ° C;
  • existence of a chronic respiratory pathology (including asthma and COPD in the first row);
  • pregnant women ;
  • protected minors and adults, persons deprived of their liberty;
  • not affiliated to a social security (including AME);
  • contraindication to MRI (pace maker, intracranial implants, etc.).

Sites / Locations

  • Département R3S, hôpital de la pitié-salpêtrière

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

15 COVID positive patients

15 healthy controls

Arm Description

dyspnea rating to various dyspneic stimulus

dyspnea rating to various dyspneic stimulus

Outcomes

Primary Outcome Measures

Intensity of the emotional response to hypoxic exposure (14.3 et 12.7% FIO2)
Slope of the relation between the intensity of a hypoxic stimulus to the intensity of the emotional response (visual analog scale, VAS : 0 is no pain and 10 is the worst pain)

Secondary Outcome Measures

Perception of a hypoxic stimulus induced dyspnea (14.3 et 12.7% FIO2)
ratings of dyspnea immediately after a hypoxic stimulus: Multidisciplinary Dyspnea Profile, MDP : 0 is no change and 10 is unbearable
Perception of a hypercapnic stimulus induced dyspnea (7% CO2)
ratings of dyspnea intensity and unpleasantness during a hypercapnic stimulus (visual analog scale, VAS : 0 is no pain and 10 is the worst pain)
Perception of a hypercapnic stimulus induced dyspnea (7% CO2)
ratings of dyspnea immediately after a hypercapnic stimulus: Multidisciplinary Dyspnea Profile, MDP : 0 is no change and 10 is unbearable
Perception of a inspiratory mechanical constraint induced dyspnea
ratings of dyspnea intensity and unpleasantness during an inspiratory mechanical constraint (visual analog scale, VAS: 0 is no pain and 10 is the worst pain)
Perception of a inspiratory mechanical constraint induced dyspnea
ratings of dyspnea immediately after an inspiratory mechanical constraint induced dyspnea(Multidisciplinary Dyspnea Profile, MDP: 0 is no change and 10 is unbearable)
brain MRI
Multimodal MRI (including anatomical MRI, resting-state functional MRI)

Full Information

First Posted
April 20, 2020
Last Updated
August 27, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04363749
Brief Title
COVID-19 Infection: Exploration of Respiratory Control Center Abnormalities
Acronym
CRC-COVID
Official Title
Do Respiratory Control Center Anomalies Explain the Lack of Respiratory Sensations Perceptions Observed in Patients Affected by COVID-19 ?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
January 11, 2021 (Actual)
Study Completion Date
January 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the present study is to determine whether there is a decrease in the emotional response to experimental induction of dyspnea by hypoxic stimulation in subjects with a "neurological" form of COVID-19, compared to healthy controls.
Detailed Description
SARS CoV-2 infection causes lung damage that can be severe enough to require artificial ventilation. Clinicians taking care of these patients are surprised by the scant respiratory sensations and emotional responses described by patients. This attenuation of respiratory interoception deprives clinicians of the usual warning signs during respiratory decompensation of dyspnea and its aggravation. It may be the result of central nerve damage. This hypothesis is bolstered by the observation that within the multiple clinical forms of COVID-19 infection there are some "neurological" forms (headache, anosmia, agueusia, dizziness, without respiratory signs and with little or no fever), that are most likely the consequence of olfactory penetration of the virus into the central nervous system (mechanism described for SARS CoV-1).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Neurological Complication
Keywords
SARS-CoV-2, COVID-19, dyspnea, hypoxic stimulus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
15 COVID positive patients
Arm Type
Experimental
Arm Description
dyspnea rating to various dyspneic stimulus
Arm Title
15 healthy controls
Arm Type
Active Comparator
Arm Description
dyspnea rating to various dyspneic stimulus
Intervention Type
Other
Intervention Name(s)
hypoxia : 14.3 and 12.7% FIO2, hypercapnia 7% CO2, inspiratory mechanical constraint
Intervention Description
the fraction of inspired oxygen is reduced from ~21% (room air) to 14.3 and 12.7% allowing the SpO2 to decrease to ~75%, rebreathing test allowing the PCO2 to rise to 65 mmHg, inspiratory mechanical constraint with 50 to 75% of maximum inspiratory pressure
Primary Outcome Measure Information:
Title
Intensity of the emotional response to hypoxic exposure (14.3 et 12.7% FIO2)
Description
Slope of the relation between the intensity of a hypoxic stimulus to the intensity of the emotional response (visual analog scale, VAS : 0 is no pain and 10 is the worst pain)
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Perception of a hypoxic stimulus induced dyspnea (14.3 et 12.7% FIO2)
Description
ratings of dyspnea immediately after a hypoxic stimulus: Multidisciplinary Dyspnea Profile, MDP : 0 is no change and 10 is unbearable
Time Frame
5 minutes
Title
Perception of a hypercapnic stimulus induced dyspnea (7% CO2)
Description
ratings of dyspnea intensity and unpleasantness during a hypercapnic stimulus (visual analog scale, VAS : 0 is no pain and 10 is the worst pain)
Time Frame
10 minutes
Title
Perception of a hypercapnic stimulus induced dyspnea (7% CO2)
Description
ratings of dyspnea immediately after a hypercapnic stimulus: Multidisciplinary Dyspnea Profile, MDP : 0 is no change and 10 is unbearable
Time Frame
5 minutes
Title
Perception of a inspiratory mechanical constraint induced dyspnea
Description
ratings of dyspnea intensity and unpleasantness during an inspiratory mechanical constraint (visual analog scale, VAS: 0 is no pain and 10 is the worst pain)
Time Frame
10 min
Title
Perception of a inspiratory mechanical constraint induced dyspnea
Description
ratings of dyspnea immediately after an inspiratory mechanical constraint induced dyspnea(Multidisciplinary Dyspnea Profile, MDP: 0 is no change and 10 is unbearable)
Time Frame
5 minutes
Title
brain MRI
Description
Multimodal MRI (including anatomical MRI, resting-state functional MRI)
Time Frame
1,5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - adult (≥ 18 years old, unprotected); for COVID-19 + patients: COVID-19 + diagnosis; with quantitative or qualitative anomalies in taste and smell; first symptoms appeared in less than 21 days for healthy subjects: have never presented any sign of COVID ; confirmed by recent negative serology understanding French; affiliated to social security; having a BMI between 20 and 30; preferably non-smokers and in the event of recruitment difficulties, smokers but with smoking <5 packs - year signature of the informed consent form Exclusion Criteria: respiratory signs or symptoms (rhinitis, cough, shortness of breath at rest); temperature above 37.5 ° C; existence of a chronic respiratory pathology (including asthma and COPD in the first row); pregnant women ; protected minors and adults, persons deprived of their liberty; not affiliated to a social security (including AME); contraindication to MRI (pace maker, intracranial implants, etc.).
Facility Information:
Facility Name
Département R3S, hôpital de la pitié-salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

COVID-19 Infection: Exploration of Respiratory Control Center Abnormalities

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