Covid19Phase 3AMBU-COVIDNCT04371107
Proactive Care of Ambulatory COVID19 Patients
A Phase 3 study testing consultation and Azithromycin in people with Covid19 and Azithromycin, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
On January 9, 2020, a new emerging virus was identified by WHO as being responsible for grouped cases of pneumonia in China. It is a coronavirus, SARS-CoV-2, responsible for the disease COVID-19 (Coronavirus disease). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Azithromycin, Ambulatory
- What is being tested?
- consultation and Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2020to 1 Jul 2023
- Phase
- Phase 3
- 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
Who may be able to join
- Patients treated at the CHU Amiens Picardie presenting:
- Age ≥18 years
- Showing symptoms of COVID -19 and a positive RT-PCR by nasopharyngeal swab
- Non-severe patient, outpatient (not hospitalized), without oxygen
- Having signed a consent to participate in the study
Who cannot join
- Patient with a contraindication to taking azithromycin, namely: Allergy to macrolides, Severe liver failure.
- In combination with medicines containing cisapride, colchicine, ergotamine or dihydroergotamine
- Pregnant, parturient or breastfeeding women.
- Asymptomatic patients
- Patient unable to be compliant with study protocol
- Patient under guardianship or curators, under the protection of justice or private public law.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proactive Care of Ambulatory COVID19 Patients: Open-labeled Randomized Trial
On January 9, 2020, a new emerging virus was identified by WHO as being responsible for grouped cases of pneumonia in China. It is a coronavirus, SARS-CoV-2, responsible for the disease COVID-19 (Coronavirus disease). The disease is mild in 85% of cases but the proportion of serious cases requiring hospitalization or intensive care (15%) puts stress on health structures and systems around the world.
To limit the influx of patients and avoid overstretching Health systems, containment and social distancing strategies are widely adopted.
It appears crucial to propose the easiest possible therapeutic strategy taking into account the ambulatory nature of the patients. Therefore azithromycin (AZM) is an antibiotic known to have an antiviral effect but also which has anti-inflammatory activity in addition to its antimicrobial effect. Azithromycin targets preferentially pulmonary cells (and particularly of the lines apparently affected in COVID-19 positive cases). The aim of this study is to demonstrate that AZM decreases symptom duration in COVID19 patients and diminishes the viral carriage.
Read the detailed description
On January 9, 2020, a new emerging virus was identified by WHO as being responsible for grouped cases of pneumonia in China. It is a coronavirus, SARS-CoV-2, responsible for the disease COVID-19 (Coronavirus disease). The disease is mild in 85% of cases but the proportion of serious cases requiring hospitalization or intensive care (15%) puts stress on health structures and systems around the world.
To limit the influx of patients and avoid overstretching Health systems, containment and social distancing strategies are widely adopted.
It appears crucial to propose the easiest possible therapeutic strategy taking into account the ambulatory nature of the patients. Treatment must be as safe as possible allowing a wide distribution to the symptomatic population while keeping a favorable risk/benefice balance for a patient with little symptoms.
Several studies show that azithromycin (AZM) has an anti-inflammatory effect. In patients with cystic fibrosis, AZM is known to have an anti-fibrotic effect by targeting myofibroblast cells, which considerably prolongs their lifespan. AZM acts functionally as an anti-inflammatory drug and reduces senescence associated secretory phenotype (SASP) mediators, such as IL-1beta and IL-632. AZM has also been shown to inhibit the replication of certain viruses, such as Zika and Ebola.
Therefore AZM is an antibiotic known to have an antiviral effect but also which has anti-inflammatory activity in addition to its antimicrobial effect. Azithromycin targets preferentially pulmonary cells (and particularly of the lines apparently affected in COVID-19 positive cases) Therefore, the prescription of AZM in COVID-19 + patients aims to increase the antiviral response locally at pulmonary level, while promoting a decrease in the immune response at systemic level.
Its specific effect and excellent clinical tolerance justifies its use as monotherapy in non-severe covid-19 + cases for the present study.
The aim of this study is to demonstrate that AZM decreases symptom duration in COVID19 patients and diminishes the viral carriage.
- Conditions
- Covid19, Azithromycin, Ambulatory
- Being tested
- consultation, Azithromycin
- Keywords
- Covid19, azithromycine, ambulatory
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consultationOther
Patients are followed up by teleconsultation or remote follow-up until the end of symptoms and for a maximum of 2 months
AzithromycinDrug
azithromycin treatment 500 mg on day 1 then 250 mg the following 4 days from day 2 to day 5, per os.
| Study group | Role | What they receive |
|---|---|---|
| azithromycin | Experimental | azithromycin treatment 500 mg on day 1 then 250 mg the following 4 days from day 2 to day 5, per os. Receives: Other: consultation; Drug: Azithromycin |
| symptomatic treatment | Active comparator | continuation of symptomatic treatment Receives: Other: consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of symptom duration (in days) with azithromycin treatment
Length of symptom duration (in days) with azithromycin treatment
Measured: 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 May 2020
- Study start29 Apr 2020
- Primary completion1 Jun 2020
- Study completion1 Jul 2023 (estimated)
Why it stopped: ANSM notifications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Lanoix, Pr, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371107
- Sponsor's protocol ID
- PI2020_843_0039
- Acronym
- AMBU-COVID
- Status last verified
- Mar 2023
- First submitted
- 27 Apr 2020
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Care of Ambulatory COVID19 Patients: Open-labeled Randomized Trial
- ClinicalTrials.gov ID
- NCT04371107
- Acronym / sponsor ID
- AMBU-COVID / PI2020_843_0039
- Conditions
- Covid19, Azithromycin, Ambulatory
- Keywords
- Covid19, azithromycine, ambulatory
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: ANSM notifications
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 1 May 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.
On January 9, 2020, a new emerging virus was identified by WHO as being responsible for grouped cases of pneumonia in China. It is a coronavirus, SARS-CoV-2, responsible for the disease COVID-19 (Coronavirus disease). The disease is mild in 85% of cases but the proportion of serious cases requiring hospitalization or intensive care (15%) puts stress on health structures and systems around the world.
To limit the influx of patients and avoid overstretching Health systems, containment and social distancing strategies are widely adopted.
It appears crucial to propose the easiest possible therapeutic strategy taking into account the ambulatory nature of the patients. Therefore azithromycin (AZM) is an antibiotic known to have an antiviral effect but also which has anti-inflammatory activity in addition to its antimicrobial effect. Azithromycin targets preferentially pulmonary cells (and particularly of the lines apparently affected in COVID-19 positive cases). The aim of this study is to demonstrate that AZM decreases symptom duration in COVID19 patients and diminishes the viral carriage.
Detailed description
On January 9, 2020, a new emerging virus was identified by WHO as being responsible for grouped cases of pneumonia in China. It is a coronavirus, SARS-CoV-2, responsible for the disease COVID-19 (Coronavirus disease). The disease is mild in 85% of cases but the proportion of serious cases requiring hospitalization or intensive care (15%) puts stress on health structures and systems around the world.
To limit the influx of patients and avoid overstretching Health systems, containment and social distancing strategies are widely adopted.
It appears crucial to propose the easiest possible therapeutic strategy taking into account the ambulatory nature of the patients. Treatment must be as safe as possible allowing a wide distribution to the symptomatic population while keeping a favorable risk/benefice balance for a patient with little symptoms.
Several studies show that azithromycin (AZM) has an anti-inflammatory effect. In patients with cystic fibrosis, AZM is known to have an anti-fibrotic effect by targeting myofibroblast cells, which considerably prolongs their lifespan. AZM acts functionally as an anti-inflammatory drug and reduces senescence associated secretory phenotype (SASP) mediators, such as IL-1beta and IL-632. AZM has also been shown to inhibit the replication of certain viruses, such as Zika and Ebola.
Therefore AZM is an antibiotic known to have an antiviral effect but also which has anti-inflammatory activity in addition to its antimicrobial effect. Azithromycin targets preferentially pulmonary cells (and particularly of the lines apparently affected in COVID-19 positive cases) Therefore, the prescription of AZM in COVID-19 + patients aims to increase the antiviral response locally at pulmonary level, while promoting a decrease in the immune response at systemic level.
Its specific effect and excellent clinical tolerance justifies its use as monotherapy in non-severe covid-19 + cases for the present study.
The aim of this study is to demonstrate that AZM decreases symptom duration in COVID19 patients and diminishes the viral carriage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| azithromycin | Experimental | Other: consultation, Drug: Azithromycinazithromycin treatment 500 mg on day 1 then 250 mg the following 4 days from day 2 to day 5, per os. |
| symptomatic treatment | Active comparator | Other: consultationcontinuation of symptomatic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients treated at the CHU Amiens Picardie presenting:
- Age ≥18 years
- Showing symptoms of COVID -19 and a positive RT-PCR by nasopharyngeal swab
- Non-severe patient, outpatient (not hospitalized), without oxygen
- Having signed a consent to participate in the study
Key exclusion criteria (6 listed)
- Patient with a contraindication to taking azithromycin, namely: Allergy to macrolides, Severe liver failure.
- In combination with medicines containing cisapride, colchicine, ergotamine or dihydroergotamine
- Pregnant, parturient or breastfeeding women.
- Asymptomatic patients
- Patient unable to be compliant with study protocol
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 |
|---|---|---|
| consultationPatients are followed up by teleconsultation or remote follow-up until the end of symptoms and for a maximum of 2 months | Other | azithromycin, symptomatic treatment |
| Azithromycinazithromycin treatment 500 mg on day 1 then 250 mg the following 4 days from day 2 to day 5, per os. | Drug | azithromycin |
Primary outcome
Length of symptom duration (in days) with azithromycin treatment
Time frame: up to 2 months
Length of symptom duration (in days) with azithromycin treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- 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.
Jean-Philippe Lanoix, Pr principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing consultation and Azithromycin in people with Covid19 and Azithromycin, run by Centre Hospitalier Universitaire, Amiens 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 5 inclusion and 6 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: paused, as of the sponsor's last update on 21 Mar 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Length of symptom duration (in days) with azithromycin treatment (time frame: up to 2 months). 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 21 Mar 2023.