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PROne Positioning in coVID-19 Oxygeno-dependent Patients in Spontaneous Ventilation (PROVID Study) (PROVID)

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ClinicalTrials.gov Identifier: NCT04366856
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The COVID epidemics is responsible for a huge number of death following COVID acute respiratory failure. First instance treatment includes oxygenotherapy up to 15L/min in spontaneous ventilation. However COVID infection can ultimately lead to an acute respiratory distress syndrome (ARDS) requiring mechanical ventilation in the intensive care unit (ICU). Guidelines on ARDS management are based on small ventilation volume (6 mL/kg), a pulmonary end expiratory pressure (PEEP) chosen to get the best pulmonary compliance, a plateau pressure lower than 30 cm of water and daily prone positioning when PaO2/FiO2 ratio is lower than 150. In ventilated ARDS patients, prone positioning has shown survival improvement. Though they applied this optimized management of ARDS patients, Chinese intensivists have recently reported mortality rate higher than 50% in ARDS COVID patients requiring intubation and mechanical ventilation. Before being intubated and admitted to ICU, COVID patients require increasing rate of oxygen delivery. From the start of the epidemics, we have observed that an oxygenotherapy rate higher than 3L/min at the initial phase of the disease was associated with a high risk of severe acute respiratory distress (30%)

The investigators hypothesize that prone positioning in patients in spontaneous ventilation (not tubed) from the stage of oxygenotherapy higher than 3L/min (to get an SpO2 of 95% or higher) would prevent respiratory worsening and the need for intubation. Prone positioning is easy to apply in patients in spontaneous ventilation since they can change position by themselves.


Condition or disease Intervention/treatment Phase
COVID ARDS Behavioral: 1: Prone positioning Behavioral: 2: No instruction regarding positioning Not Applicable

Detailed Description:

Patients admitted to the hospital with laboratory-confirmed SARS-CoV-2 infection as determined by PCR and/or CT scan showing typical radiological findings (ground glass abnormalities) and requiring O2 3L/min to get an SpO2 higher or equal to 95%.

Patients will be randomised for their position : a group with prone positioning at least 6 hours a day during hosital stay until oxygen weaning or intubation (interventional group) and a group with no instruction regarding positioning (control group). In the interventional group, patients will be suggested to spend 6 hours or more in prone position and will report themselves the time spent in prone position each day. In the control group, patients won't be given any instruction regarding positioning.

Patients will be clinically assessed as usual : monitoring 4 to 8 times a day in the ward and continuous monitoring in ICU.

The need for admission to ICU, high flow nasal oxygenation, non invasive ventilation or intubation or the occurrence of death will be recorded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PROne Positioning in coVID-19 Oxygeno-dependent Patients in Spontaneous Ventilation (PROVID Study)
Actual Study Start Date : June 26, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: 1: Prone positioning
the interventional group will be suggested to spend at least 6 hours a day in prone position
Behavioral: 1: Prone positioning
the interventional group will be suggested to spend at least 6 hours a day in prone position

2: No instruction regarding positioning
the control group will get no instruction regarding positioning
Behavioral: 2: No instruction regarding positioning
group with no instruction regarding positioning (control group)




Primary Outcome Measures :
  1. Proportion of patients who meet one or both following criteria: need for intubation (for mechanical ventilation), occurrence of death during hospital stay. [ Time Frame: At day28 ]

Secondary Outcome Measures :
  1. Proportion of patients admitted to ICU (for patients included out of ICU) [ Time Frame: At day28 ]
  2. Days alive and free from non invasive ventilation (NIV) or high flow nasal canula oxygen delivery (HFNC) (for those neither under NIV or HFNC at the time of study inclusion) [ Time Frame: At day28 ]
  3. Days alive and out of ICU [ Time Frame: At day28 ]
  4. Days alive and out of hospital [ Time Frame: At day28 ]
  5. Maximum oxygenotherapy rate during hospital stay [Time Frame: At day28] [ Time Frame: At day28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted to the hospital
  • Laboratory-confirmed SARS-CoV-2 infection as determined by PCR and/or CT scan showing typical radiological findings (ground glass abnormalities)
  • Need for O2 3L/min to get an SpO2 higher or equal to 95%.
  • Patient able to understand and to get in prone postion themself
  • No therapeutic limitation

Exclusion Criteria:

  • Age > 80 years
  • Pregnancy
  • Impossibility to get in prone position

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): NCT04366856


Contacts
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Contact: Anatole HARROIS, MD +33(0)1-45-21-34-41 anatole.harrois@aphp.fr

Locations
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France
Département d'Anesthésie Réanimation - Kremlin Bicêtre Recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Anatole HARROIS, MD, PhD    +33(0)1-45-21-34-41    anatole.harrois@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Anatole HARROIS Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04366856    
Other Study ID Numbers: APHP200504
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: August 19, 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 Assistance Publique - Hôpitaux de Paris:
ARDS
SARS-Cov-2 infection
Prone position
Oxygenotherapy
Intubation