Azithromycin for COVID-19 Treatment in Outpatients Nationwide (ACTION)

Thomas M. Lietman

Status and phase: Terminated; Phase 3

Conditions: COVID-19; SARS-CoV-2

Treatments: Drug: Azithromycin; Drug: Placebos

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04332107

20-30504

Details and patient eligibility

About

This individually randomized telemedicine-based trial aims to evaluate the efficacy of a single dose of azithromycin for prevention of progression of COVID-19 in patients with a recent positive SARS-CoV-2 test who are not currently hospitalized.

Full description

Identification of a safe, effective treatment for individuals with mild or moderate COVID-19 that prevents disease progression and reduces hospitalization would reduce the burden on the health system. High dose hydroxychloroquine is being evaluated for SARS-CoV-2 prevention and COVID-19 disease treatment, but has a high risk of a number of potentially severe adverse events. Recent evidence has indicated that the broad-spectrum macrolide azithromycin may have some activity against coronaviruses. Here we propose an individually-randomized, placebo-controlled trial to determine the efficacy of a single dose of azithromycin for prevention of COVID-19.

Potential participants will undergo remote eligibility screening with study staff prior to enrollment. Upon determination of eligibility and signing electronic informed consent documents, participants will be emailed baseline study forms and will be mailed their randomized study treatment. At the end of the study (21 days), participants will be emailed a final study questionnaire. Note that there will no contact between study staff and participants in this trial, minimizing risk of infection spread.

Enrollment: 263 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Evidence of a positive SARS-CoV-2 test and test results received within the previous seven days
• Not currently hospitalized
• Willing and able to receive study drug by mail
• Willing and able to do the study questionnaires at baseline, day 3, 7, 14, 21 days via email or over the phone
• No known allergy or other contraindication to macrolides
• Age 18 years or older at the time of enrollment
• No known history of prolongation of the QT interval (eg. History of torsades de pointes, congenital long QT syndrome, bradyarrhthmia)
• No recent use of hydroxychloroquine within the past 7 days for participants >55 years of age
• Not currently taking nelfinavir or warfarin (Coumadin)
• Provision of informed consent
• Not currently pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

263 participants in 2 patient groups, including a placebo group

Azithromycin

Experimental group

Description:

1.2g of oral azithromycin

Treatment:

Drug: Azithromycin

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebos