A multi-centre open-label two-arm randomised superiority clinical trial of Azithromycin versus usual care in ambulatory COVID-19 (ATOMIC2)

Call for study partners and trial sites
The ATOMIC2 trial is looking for 2 or 3 sites in Latin America or India that are hospitals with large emergency department populations and experienced in Phase III trials. Read more

The purpose of the ATOMIC2 study is to assess whether the use of a commonly given antibiotic called Azithromycin can prevent COVID-19 patients from getting worse, specifically in people who go to hospital but who doctors decide there is no need to admit to hospital for treatment.

Primary objective: To compare the effect of Azithromycin in participants with a clinical diagnosis of COVID-19 in reducing the proportion with either death or hospital admission with respiratory failure requiring Non-Invasive Mechanical Ventilation (NIV) or Invasive Mechanical Ventilation (IMV) over the 28 days from randomization

Type of study: Interventional; Phase II/III, treatment

Treatment tested: Azithromycin

Study documents:
Master protocol

Countries: confirmed: UK; with possible extension to South America and South Asia (looking for new sites)

Sample size: 800

Study participants: Adults, ≥18 years of age with clinically diagnosed COVID-19 infection, managed initially as outpatients

Study status: Recruiting

Principal investigators

More information

Call for study partners and trial sites

The ATOMIC2 trial is an open-label, randomised trial of 2 weeks of Azithromycin in patients with COVID-19 in the first 14 days of symptoms, presenting to hospitals but considered suitable for initial outpatient care, i.e., not immediately requiring oxygen or respiratory support. 

The study is looking for two or three sites in Latin America or India that are hospitals with large emergency department populations. Sites should be experienced in Phase III trials and able to commence enrolment within 2-4 weeks.

The study sponsor, the University of Oxford, can providing funding for the clinical research site team; the study drug; an iPAD for electronic screening/enrolment/CRF/randomisation; electronic (REDCap) database and CRF; sample collection equipment; virtual site initiation visits (90 minutes); and additional online video training for wider team members (33 mins + 15 mins).

Sites would screen patients, consent, randomise, perform telephone follow-up at days 14 and 28, and complete a daily CRF on volunteers who are admitted during the trial period; and collect samples (a throat swab only, to be kept in a freezer and shipped at end of study). Other samples are not required.

Interested sites should contact timothy.hinks@ndm.ox.ac.uk

Please also see the study website for more information.

Last updated: June 2020

Disclaimer
Note that study-related documents posted on the COVID-19 Clinical Research Coalition (COVID-19 CRC) website have been shared by coalition members for information. Some may have been approved by Ethics Review Boards and others may still be in draft form. Documents posted here may have been further amended before being used in the conduct of the respective trials they were designed for. It is recommended that users review these documents carefully and, if they plan to use them, adapt them appropriately for their intended use. The COVID-19 CRC and its members cannot accept any liability for any claim, loss or damages as a result of any reliance placed on, or use of, these documents.


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