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Proactive Care of Ambulatory COVID19 Patients (AMBU-COVID)

C

Centre Hospitalier Universitaire, Amiens

Status and phase

Suspended
Phase 3

Conditions

Ambulatory
Azithromycin
Covid19

Treatments

Drug: Azithromycin
Other: consultation

Study type

Interventional

Funder types

Other

Identifiers

NCT04371107
PI2020_843_0039

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

11 participants in 2 patient groups

azithromycin
Experimental group
Description:
azithromycin treatment 500 mg on day 1 then 250 mg the following 4 days from day 2 to day 5, per os.
Treatment:
Drug: Azithromycin
Other: consultation
symptomatic treatment
Active Comparator group
Description:
continuation of symptomatic treatment
Treatment:
Other: consultation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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