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

June 30, 2020 updated by: Centre d'Investigation Clinique et Technologique 805

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Benjamin Davido

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed within 7 days after admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed at day 1
Risk factors 2
Time Frame: Assessed at day 1
Studying if comorbidities were associated with an unfavorable outcome
Assessed at day 1
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)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre d'Investigation Clinique et Technologique 805

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2020

Primary Completion (Actual)

April 25, 2020

Study Completion (Actual)

April 25, 2020

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 1, 2020

Study Record Updates

Last Update Posted (Actual)

July 1, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZITHROVID
  • INDS (Registry Identifier: MR1811190620)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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