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Clinical Trials/NCT04453501
NCT04453501
Completed
Not Applicable

Interest of Azithromycin With or Without Hydroxychloroquine for the Treatment of COVID-19 Pneumonia : a Retrospective Observational Study

Centre d'Investigation Clinique et Technologique 8051 site in 1 country132 target enrollmentMarch 2, 2020

Overview

Phase
Not Applicable
Intervention
favorable outcome
Conditions
COVID
Sponsor
Centre d'Investigation Clinique et Technologique 805
Enrollment
132
Locations
1
Primary Endpoint
Favorable outcome
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2, 2020
End Date
April 25, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre d'Investigation Clinique et Technologique 805
Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

Azithromycin or non-azithromycin group

Patient who received during admission for a severe COVID-19 pneumonia, azithromycin +/-hydroxychloroquine or no azithromycin.

Intervention: favorable outcome

Outcomes

Primary Outcomes

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 Outcomes

  • Interest of anti-infective agents(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)
  • Risk factors 1(Assessed at day 1)
  • Risk factors 2(Assessed at day 1)

Study Sites (1)

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