NCT04371107

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
11

participants targeted

Target at below P25 for phase_3 covid19

Timeline
Completed

Started Apr 2020

Longer than P75 for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

April 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

April 27, 2020

Last Update Submit

March 17, 2023

Conditions

Covid19AzithromycinAmbulatory

Keywords

Covid19azithromycineambulatory

Outcome Measures

Primary Outcomes (1)

  • Length of symptom duration (in days) with azithromycin treatment

    Length of symptom duration (in days) with azithromycin treatment

    up to 2 months

Study Arms (2)

azithromycin

EXPERIMENTAL

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

Other: consultationDrug: Azithromycin

symptomatic treatment

ACTIVE COMPARATOR

continuation of symptomatic treatment

Other: consultation

Interventions

consultationOTHER

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

azithromycinsymptomatic treatment
AzithromycinDRUG

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

azithromycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Referral and ConsultationAzithromycin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services AdministrationErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Jean-Philippe Lanoix, Pr

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2020

First Posted

May 1, 2020

Study Start

April 29, 2020

Primary Completion

June 1, 2020

Study Completion

July 1, 2023

Last Updated

March 21, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)