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Measurement of the Efficacy of MORPHINE in the Early Management of Dyspnea in COVID-19 Positive Patients (CODYS)

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ClinicalTrials.gov Identifier: NCT04522037
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

Morphine is used in the treatment of dyspnea and polypnea with a proven benefit on the improvement of these symptoms, both etiologically and symptomatically. This medication is used in particular in palliative care for this type of symptom.

The Sars CoV2 viral pneumonia table can lead to respiratory distress. In patients with moderate to severe impairment without goal of resuscitation (level of care 3 and 4), the introduction of morphine may sometimes be necessary to relieve respiratory symptoms. These also lead to major exhaustion which can worsen the clinical picture. However, the prescription of morphine is not systematic in front of a respiratory distress table.

The investigators hypothesized that early treatment with morphine lead to a better management of dyspnea, quality of live and survival in COVID-19 positive participants patients when there is not resuscitation objective management (level of care 3 and 4).

The objective is to measure the efficacy of morphine in the early management of dyspnea, quality of life and survival in COVID-19 positive participants patients treated in the Hospices Civils of Lyon during COVID-19 pandemic.


Condition or disease Intervention/treatment
Patients Hospitalized in the Hospices Civils of Lyon COVID-19 Disease Moderate to Severe Dyspnea Without Resuscitation Objective Management Other: No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study of the Measurement of the Efficacy of MORPHINE in the Early Management of Dyspnea in COVID-19 Positive Patients With Moderate to Severe Impairment Without Objective of Resuscitation Management (Level of Care 3 and 4) at the Hospices Civils of Lyon
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
interventional group
patients hospitalized at the hospices civils of Lyon with a level of care 3 or 4 receiving morphinic treatment for COVID-19 disease dyspnea.
 Other: No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups
Respiratory rate is analyzed with the scope (approved by the French national medical authorities)
control group
patients hospitalized at the hospices civils of Lyon with a level of care 3 or 4 not receiving morphinic treatment for COVID-19 disease dyspnea.
 Other: No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups
Respiratory rate is analyzed with the scope (approved by the French national medical authorities)


Outcome Measures
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Primary Outcome Measures :
  1. Title : Reduction of respiratory rate between Hour 0 and Hour 12 at initiation of morphine treatment [ Time Frame: Hour 0 and Hour 12 after initiation of morphinic treatment ]
    The respiratory rate is analyzed at Hour 0 and Hour 12 by a scope.


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:   No
Sampling Method:   Non-Probability Sample
Study Population
patients hospitalized at the hospices civils of Lyon with a level of care 3 or 4 receiving morphinic and not receiving morphinic treatment for COVID-19 disease dyspnea.
Criteria

Inclusion Criteria:

  • Age over 18 years.
  • Having had a Covid-19 respiratory disease confirmed by PCR or TDM or anamnestic criterion for patients living in communities for the elderly (respiratory symptomatology suggestive and at least 3 cases confirmed in the living environment).
  • Having had respiratory severity criteria: respiratory distress syndrome including FR> 25 / min and oxygen-demand> 4 L / min to maintain a SpO2> 90% at inclusion.
  • Having had a defined level of care after collegial discussion notified in the file rejecting the external cardiac massage and admission to the intensive care unit (Level 3 and 4 on the protocols of the Hospices Civils de Lyon).
  • Collection of non-opposition

Exclusion Criteria:

-

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): NCT04522037


Contacts
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Contact: Myriam Legenne 4 72 07 25 79 ext +33 myriam.legenne@chu-lyon.fr

Locations
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France
Hôpital de la Croix Rousse / GHN Recruiting
Lyon, France, 69004
Contact: Myriam Legenne, Dr    4 72 07 25 79 ext +33    myriam.legenne@chu-lyon.fr   
Hôpital Edouard Herriot Recruiting
Lyon, France, 69008
Contact: Sophie Francioni, Dr    4 72 11 96 08 ext +33    sophie.francioni@chu-lyon.fr   
Hôpital Lyon Sud Recruiting
Pierre-Bénite, France, 69445
Contact: Guillaume Economos, Dr    4 78 86 41 48 ext +33    guillaume.economos@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04522037    
Other Study ID Numbers: CODYS_2020
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: July 2020

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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 Hospices Civils de Lyon:
COVID-19 disease
level of care 3 and 4
morphinic treatment
dyspnea
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Morphine
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents