Proactive Care of Ambulatory COVID19 Patients

NCT ID: NCT04371107

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE3
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-29
• Study Completion Date: 2023-07-01

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.

Conditions

Covid19; Azithromycin; Ambulatory

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

azithromycin

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

Group Type: EXPERIMENTAL

consultation

Intervention Type: OTHER

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

Azithromycin

Intervention Type: DRUG

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

symptomatic treatment

continuation of symptomatic treatment

Group Type: ACTIVE_COMPARATOR

consultation

Intervention Type: OTHER

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

Interventions

consultation

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

Intervention Type: OTHER

Azithromycin

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Philippe Lanoix, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

CHU Amiens

Amiens, , France

Countries

France

Other Identifiers

PI2020_843_0039

Identifier Type: -

Identifier Source: org_study_id