Proactive Care of Ambulatory COVID19 Patients (AMBU-COVID)
Primary Purpose
Covid19, Azithromycin, Ambulatory
Status
Suspended
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
consultation
Azithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Covid19, azithromycine, ambulatory
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- CHU Amiens
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
azithromycin
symptomatic treatment
Arm Description
azithromycin treatment 500 mg on day 1 then 250 mg the following 4 days from day 2 to day 5, per os.
continuation of symptomatic treatment
Outcomes
Primary Outcome Measures
Length of symptom duration (in days) with azithromycin treatment
Length of symptom duration (in days) with azithromycin treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT04371107
First Posted
April 27, 2020
Last Updated
March 17, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT04371107
Brief Title
Proactive Care of Ambulatory COVID19 Patients
Acronym
AMBU-COVID
Official Title
Proactive Care of Ambulatory COVID19 Patients: Open-labeled Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Suspended
Why Stopped
ANSM notifications
Study Start Date
April 29, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Azithromycin, Ambulatory
Keywords
Covid19, azithromycine, ambulatory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
azithromycin
Arm Type
Experimental
Arm Description
azithromycin treatment 500 mg on day 1 then 250 mg the following 4 days from day 2 to day 5, per os.
Arm Title
symptomatic treatment
Arm Type
Active Comparator
Arm Description
continuation of symptomatic treatment
Intervention Type
Other
Intervention Name(s)
consultation
Intervention Description
Patients are followed up by teleconsultation or remote follow-up until the end of symptoms and for a maximum of 2 months
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
azithromycin treatment 500 mg on day 1 then 250 mg the following 4 days from day 2 to day 5, per os.
Primary Outcome Measure Information:
Title
Length of symptom duration (in days) with azithromycin treatment
Description
Length of symptom duration (in days) with azithromycin treatment
Time Frame
up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Lanoix, Pr
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Proactive Care of Ambulatory COVID19 Patients
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