Proactive Care of Ambulatory COVID19 Patients

Covid19 Clinical Trial

— AMBU-COVID  

Official title:

Proactive Care of Ambulatory COVID19 Patients: Open-labeled Randomized Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04371107
• Other study ID #: PI2020_843_0039
• Status: Suspended
• Phase: Phase 3
• Start date: April 29, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 11
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ambulatory
• Azithromycin
• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of symptom duration (in days) with azithromycin treatment	Length of symptom duration (in days) with azithromycin treatment	up to 2 months