Clinical trial NCT04371107: Proactive Care of Ambulatory COVID19 Patients
Official title: Proactive Care of Ambulatory COVID19 Patients: Open-labeled Randomized Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Covid19
Azithromycin
Ambulatory
Keywords: Covid19
azithromycine
ambulatory
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Length of symptom duration (in days) with azithromycin treatment
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Jean-Philippe Lanoix, Pr
role: PRINCIPAL_INVESTIGATOR
References: