Anti Infective Agents Impact in COVID-19 Pneumonia

NCT04453501 | Completed DMC FDA Drug

• 2 other identifiers: AZITHROVIDINDS
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Pneumonia, Viral

Keywords

azithromycin; hydroxychloroquine; COVID-19; pneumonia; hospitalization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Risk factors 1

  Assessed at day 1

• Risk factors 2

  Assessed at day 1

• 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

Study Arms (1)

Azithromycin or non-azithromycin group

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

Drug: favorable outcome

Interventions

favorable outcome DRUG

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

Azithromycin or non-azithromycin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead

Study Sites (1)

Benjamin Davido

Garches, 92380, France

Location

MeSH Terms

Conditions

Pneumonia, Viral; COVID-19; Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 1, 2020
• Study Start: March 2, 2020
• Primary Completion: April 25, 2020
• Study Completion: April 25, 2020
• Last Updated: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)