ATOMIC2, Version 1.0 [COVID-19]

• Research type

  Research Study

• Full title

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

• IRAS ID

  282892

• Contact name

  Timothy Hinks

• Contact email

  atomic2@ndorms.ox.ac.uk

• Sponsor organisation

  University of Oxford, Clinical Trials and Research Governance

• Eudract number

  2020-001740-26

• Duration of Study in the UK

  0 years, 11 months, 30 days

• Research summary

  Summary of Research
  Coronavirus-induced disease 2019 (COVID-19) is an infection caused by a virus whose full name is severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This is a new and rapidly-spreading infectious disease. Those people that come into contact with the virus can have symptoms such as a mild fatigue, fever, loss of taste and a persistent cough, which can develop into severe respiratory failure requiring hospitalisation and mechanical ventilation. For those where the symptoms worsen this typically occurs 1 to 2 weeks into coming in contact with the virus. This provides a window of opportunity to potentially treat those patients who present with symptoms before becoming seriously ill to take a drug that might not result in them developing the severe symptoms. The ATOMIC2 study is investigating if a common antibiotic called Azithromycin (AZM) may prevent the patients from getting worse. Azithromycin is a safe, inexpensive, antibiotic that is available worldwide and is often prescribed by doctors across the world and it has been proved to have a wide range of antibacterial, anti-inflammatory and antiviral properties.\n\nIn this study, researchers want to investigate whether the use of a commonly given antibiotic called Azithromycin for 14 days can prevent COVID-19 symptoms from getting worse in patients, who go to the hospital, but doctors decide there is no need to admit them for treatment. The patients will be randomly allocated to receive Azithromycin and standard care or standard care alone. \n

  Summary of Results
  Coronavirus-induced disease 2019 (COVID-19) is an infection caused by a virus whose full name is severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This is a new and rapidly-spreading infectious disease. Those people that come into contact with the virus can have symptoms such as a mild fatigue, fever, loss of taste and a persistent cough, which can develop into severe respiratory failure requiring hospitalisation and mechanical ventilation. For those where the symptoms worsen this typically occurs 1 to 2 weeks into coming in contact with the virus. This provides a window of opportunity to potentially treat those patients who present with symptoms before becoming seriously ill to take a drug that might not result in them developing the severe symptoms. The ATOMIC2 study is investigating if a common antibiotic called Azithromycin (AZM) may prevent the patients from getting worse. Azithromycin is a safe, inexpensive, antibiotic that is available worldwide and is often prescribed by doctors across the world and it has been proved to have a wide range of antibacterial, anti-inflammatory and antiviral properties.

  In this study, researchers want to investigate this medicine in patients who have mild symptoms of COVID-19 who go to the hospital, but who doctors decide there is no need to admit them for treatment. The study will investigate if half the patients are given Azithromycin for 14 days and half the patients do not receive Azithromycin, are there less people after 28 days in one of the groups who go on to develop more severe symptoms from COVID-19.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  20/HRA/2105

• Date of REC Opinion

  5 May 2020

• REC opinion

  Further Information Favourable Opinion