Official Title
Proactive Care of Ambulatory COVID19 Patients: Open-labeled Randomized Trial
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.

Suspended
COVID19
Azithromycin
Ambulatory

Other: consultation

Patients are followed up by teleconsultation or remote follow-up until the end of symptoms and for a maximum of 2 months

Drug: Azithromycin

azithromycin treatment 500 mg on day 1 then 250 mg the following 4 days from day 2 to day 5, per os.

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

CHU Amiens
Amiens, France

Jean-Philippe Lanoix, Pr, Principal Investigator
CHU Amiens

Centre Hospitalier Universitaire, Amiens
NCT Number
Keywords
COVID19
azithromycine
ambulatory
MeSH Terms
COVID-19
Azithromycin