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

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

• Registration Number: NCT04522037
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-08-20
• Last Update Submitted: 2020-08-20
• Study First Posted: 2020-08-21
• Last Update Posted: 2020-08-21
• Primary Completion: 2020-09
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups	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.
interventional group	No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups	patients hospitalized at the hospices civils of Lyon with a level of care 3 or 4 receiving morphinic treatment for COVID-19 disease dyspnea.

Primary Outcome Measures

Name	Time	Method
Title : Reduction of respiratory rate between Hour 0 and Hour 12 at initiation of morphine treatment	Hour 0 and Hour 12 after initiation of morphinic treatment	The respiratory rate is analyzed at Hour 0 and Hour 12 by a scope.

Trial Locations

Locations (3)

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Hôpital de la Croix Rousse / GHN; 🇫🇷 Lyon, France

Hôpital Lyon Sud; 🇫🇷 Pierre-Bénite, France