COVIDAZITHROVIDNCT04453501
Anti Infective Agents Impact in COVID-19 Pneumonia
An observational study of COVID and Pneumonia, Viral, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Pneumonia, Viral
- What is being tested?
- favorable outcome
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2020to 25 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted at Hopital Raymond Poincaré, Garches, France in a medical ward for a COVID-19 pneumonia
Who may be able to join
- 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
Who cannot join
- patient opposed to data collected, or who could not consent because of a serious presentation of the pneumonia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID, Pneumonia, Viral
- Being tested
- favorable outcome
- Keywords
- azithromycin, hydroxychloroquine, COVID-19, pneumonia, hospitalization
- Medical subject headings
- Pneumonia, Viral, COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
favorable outcomeDrug
Whether patient under such regimen had a favorable outcome (no transfer in intensive care unit or death)
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin or non-azithromycin group | Patient who received during admission for a severe COVID-19 pneumonia, azithromycin +/-hydroxychloroquine or no azithromycin. Receives: Drug: favorable outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed within 7 days after admission
Secondary outcomes (3)
Risk factors 1
Studying if biological abnormalities (lymphocyte count or CRP) at admission were associated with an unfavorable outcome
Measured: Assessed at day 1
Risk factors 2
Studying if comorbidities were associated with an unfavorable outcome
Measured: Assessed at day 1
Interest of anti-infective agents
Studying whether any regimen was associated with a favorable outcome (including azithromycin)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start2 Mar 2020
- Primary completion25 Apr 2020
- Study completion25 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453501
- Sponsor's protocol ID
- AZITHROVID
- Other IDs
- INDS
- Acronym
- AZITHROVID
- Status last verified
- Jun 2020
- First submitted
- 25 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Azithromycin With or Without Hydroxychloroquine for the Treatment of COVID-19 Pneumonia : a Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT04453501
- Acronym / sponsor ID
- AZITHROVID / AZITHROVID
- Conditions
- COVID, Pneumonia, Viral
- Keywords
- azithromycin, hydroxychloroquine, COVID-19, pneumonia, hospitalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 25 Apr 2020 (actual)
- Study completion
- 25 Apr 2020 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azithromycin or non-azithromycin group | – | Drug: favorable outcomePatient who received during admission for a severe COVID-19 pneumonia, azithromycin +/-hydroxychloroquine or no azithromycin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted at Hopital Raymond Poincaré, Garches, France in a medical ward for a COVID-19 pneumonia
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- patient opposed to data collected, or who could not consent because of a serious presentation of the pneumonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| favorable outcomeWhether patient under such regimen had a favorable outcome (no transfer in intensive care unit or death) | Drug | Azithromycin or non-azithromycin group |
Primary outcome
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.
3 secondary outcomes
Risk factors 1
Time frame: Assessed at day 1
Risk factors 2
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Pneumonia, Viral, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable outcome (time frame: Assessed within 7 days after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.