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Anti Infective Agents Impact in COVID-19 Pneumonia (AZITHROVID)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04453501
Recruitment Status : Completed
First Posted : July 1, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

Brief Summary:

During COVID-19 epidemic, hydroxychloroquine was proposed and authorized as a possible key agent in the treatment of COVID-19 hospitalized pneumonia, including in France. Gautret et al. proposed the combination regimen with azithromycin. However only one study reported the interest of azithromycin alone.

Retrospective study reporting the impact of the anti-infective agents used during the pandemic in a tertiary care hospital, using azithromycin with or without hydroxychloroquine.


Condition or disease Intervention/treatment
COVID Pneumonia, Viral Drug: favorable outcome

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Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Interest of Azithromycin With or Without Hydroxychloroquine for the Treatment of COVID-19 Pneumonia : a Retrospective Observational Study
Actual Study Start Date : March 2, 2020
Actual Primary Completion Date : April 25, 2020
Actual Study Completion Date : April 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
Azithromycin or non-azithromycin group
Patient who received during admission for a severe COVID-19 pneumonia, azithromycin +/-hydroxychloroquine or no azithromycin.
Drug: favorable outcome
Whether patient under such regimen had a favorable outcome (no transfer in intensive care unit or death)




Primary Outcome Measures :
  1. Favorable outcome [ Time Frame: Assessed within 7 days after admission ]
    After being admitted, patient was monitored whether he does not required to be transferred in ICU or died because of a severe COVID-19 pneumonia within 7 days. The outcome was purely clinical. If patient was discharged at home after admission and/or was transferred into a rehabilitation center he was considered as a favorable outcome independently of any biological marker.


Secondary Outcome Measures :
  1. Risk factors 1 [ Time Frame: Assessed at day 1 ]
    Studying if biological abnormalities (lymphocyte count or CRP) at admission were associated with an unfavorable outcome

  2. Risk factors 2 [ Time Frame: Assessed at day 1 ]
    Studying if comorbidities were associated with an unfavorable outcome

  3. Interest of anti-infective agents [ Time Frame: From date of inclusion until the date of first documented progression to ICU or date of death from any cause, whichever came first, assessed up to 2 months ]
    Studying whether any regimen was associated with a favorable outcome (including azithromycin)



Information from the National Library of Medicine

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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
All patients admitted at Hopital Raymond Poincaré, Garches, France in a medical ward for a COVID-19 pneumonia
Criteria

Inclusion Criteria:

  • aged over 18 years old
  • hospitalized for a COVID-19 pneumonia documented by PCR or lung tomodensitometry,
  • admitted outside an intensive care unit, in a medicine ward

Exclusion Criteria:

  • patient opposed to data collected, or who could not consent because of a serious presentation of the pneumonia

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): NCT04453501


Locations
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France
Benjamin Davido
Garches, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
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Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT04453501    
Other Study ID Numbers: AZITHROVID
INDS ( Registry Identifier: MR1811190620 )
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Centre d'Investigation Clinique et Technologique 805:
azithromycin
hydroxychloroquine
COVID-19
pneumonia
hospitalization
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases