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Proactive Care of Ambulatory COVID19 Patients (AMBU-COVID)

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ClinicalTrials.gov Identifier: NCT04371107
Recruitment Status : Not yet recruiting
First Posted : May 1, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.


Condition or disease Intervention/treatment Phase
Covid19 Azithromycin Ambulatory Other: consultation Drug: Azithromycin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proactive Care of Ambulatory COVID19 Patients: Open-labeled Randomized Trial
Estimated Study Start Date : April 29, 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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

Active Comparator: symptomatic treatment
continuation of symptomatic treatment
Other: consultation
Patients are followed up by teleconsultation or remote follow-up until the end of symptoms and for a maximum of 2 months




Primary Outcome Measures :
  1. Length of symptom duration (in days) with azithromycin treatment [ Time Frame: up to 2 months ]
    Length of symptom duration (in days) with azithromycin treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371107


Contacts
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Contact: Jean-Philippe Lanoix, Pr (33)322088370 Lanoix.Jean-Philippe@chu-amiens.fr
Contact: Jean-Philippe Lanoix (33)322088370 Lanoix.Jean-Philippe@chu-amiens.fr

Locations
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France
CHU Amiens
Amiens, France, 80480
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Jean-Philippe Lanoix, Pr CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04371107    
Other Study ID Numbers: PI2020_843_0039
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Covid19
azithromycine
ambulatory
Additional relevant MeSH terms:
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Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents