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OpenTrials
Completed

NCT Number: NCT04453501

Anti Infective Agents Impact in COVID-19 Pneumonia

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.

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Key information

Conditions

COVID COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Benjamin Davido

Garches, 92380, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

favorable outcome

Drug

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

Primary outcomes

  1. 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

  1. 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

  2. Risk factors 2

    Time frame: Assessed at day 1

    Studying if comorbidities were associated with an unfavorable outcome

  3. 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)

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Registry information

Official study title

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

Acronym: AZITHROVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 1, 2020
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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