Anti Infective Agents Impact in COVID-19 Pneumonia

COVID Clinical Trial

— AZITHROVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04453501
• Other study ID #: AZITHROVID
• Secondary ID: INDS
• Status: Completed
• Start date: March 2, 2020
• Est. completion date: April 25, 2020

Study information

• Verified date: June 2020
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: April 25, 2020
• Est. primary completion date: April 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• Pneumonia
• Pneumonia, Viral

Intervention

Drug:
• favorable outcome
Whether patient under such regimen had a favorable outcome (no transfer in intensive care unit or death)

Locations

Country	Name	City	State
France	Benjamin Davido	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Favorable outcome	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	Risk factors 1	Studying if biological abnormalities (lymphocyte count or CRP) at admission were associated with an unfavorable outcome	Assessed at day 1
Secondary	Risk factors 2	Studying if comorbidities were associated with an unfavorable outcome	Assessed at day 1
Secondary	Interest of anti-infective agents	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