Anti Infective Agents Impact in COVID-19 Pneumonia

Completed

• Conditions: COVID; Pneumonia, Viral
• Interventions: Drug: favorable outcome

• Registration Number: NCT04453501
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-02
• Primary Completion: 2020-04-25
• Study Completion: 2020-04-25
• Status Verified: 2020-06
• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-30
• Last Update Submitted: 2020-06-30
• Study First Posted: 2020-07-01
• Last Update Posted: 2020-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Azithromycin or non-azithromycin group	favorable outcome	Patient who received during admission for a severe COVID-19 pneumonia, azithromycin +/-hydroxychloroquine or no azithromycin.

Primary Outcome Measures

Name	Time	Method
Favorable outcome	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

Name	Time	Method
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	Studying whether any regimen was associated with a favorable outcome (including azithromycin)
Risk factors 1	Assessed at day 1	Studying if biological abnormalities (lymphocyte count or CRP) at admission were associated with an unfavorable outcome
Risk factors 2	Assessed at day 1	Studying if comorbidities were associated with an unfavorable outcome

Trial Locations

Locations (1)

Benjamin Davido; 🇫🇷 Garches, France