A Multicentre Open-label Two-arm Randomised Superiority Clinical Trial of Azithromycin Versus Usual Care In Ambulatory COVID19 (ATOMIC2)

NCT04381962

Last updated date
Study Location
Horton General Hospital
Banbury, Oxfordshire, OX3 9DU, United Kingdom
Contact
01865 227 374

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
COVID-19
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or Female, aged at least 18 years

- Assessed by the attending clinical team as appropriate for initial ambulatory (outpatient) management

- A clinical diagnosis of highly-probable COVID-19 infection (diagnosis by the attending clinical team)

- No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial

- Able to understand written English (for the information and consent process) and be able to give informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Known hypersensitivity to any Macrolide including Azithromycin, Ketolide antibiotic,
or the excipients including an allergy to soya or peanuts.


- Known fructose intolerance, glucose-galactose malabsorption or
sucrose-isomaltase-insufficiency


- Currently on a Macrolide antibiotic (Clarithromycin, Azithromycin, Erythromycin,
Telithromycin, Spiramycin)


- On any SSRI (Selective Serotonin Reuptake Inhibitor)


- Elevated cardiac troponin at initial assessment suggestive of significant myocarditis
(if clinically the clinical team have felt it appropriate to check the patient's
troponin levels)


- Evidence of QTc prolongation: QTc>480ms


- Significant electrolyte disturbance (e.g. hypokalaemia K+<3.5 mmol/L)


- Clinically relevant bradycardia (P<50 bpm), non-sustained ventricular tachycardia or
unstable severe cardiac insufficiency


- Currently on hydroxychloroquine or chloroquine

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Multicentre Open-label Two-arm Randomised Superiority Clinical Trial of Azithromycin Versus Usual Care In Ambulatory COVID19 (ATOMIC2)
Official Title  ICMJE A Multi-centre Open-label Two-arm Randomised Superiority Clinical Trial of Azithromycin Versus Usual Care In Ambulatory COVID-19 (ATOMIC2)
Brief Summary A multi-centre open-label two-arm randomised superiority clinical trial of two weeks of oral Azithromycin 500mg once daily versus usual care in adult patients presenting to secondary care with clinically-diagnosed COVID-19 but assessed as appropriate for initial ambulant (outpatient) management, in preventing progression to respiratory failure or death.
Detailed Description

Hypothesis: Use of Azithromycin 500 mg once daily for 14 days is effective in preventing and/or reducing the severity of lower respiratory illness of COVID-19 disease at 28 days.

Study design: Multi centre, prospective open label two-arm randomised superiority clinical trial of standard care and Azithromycin with standard care alone for those presenting to hospital with COVID-19 symptoms who are not admitted at initial presentation.

Study setting: Patients being assessed by secondary care NHS hospitals in the UK.

Participants: Adults, ?18 years of age assessed in an acute hospital with clinical diagnosis of COVID-19 infection and where medically it is decided not to admit the patient and for the patient to be managed on an ambulatory (outpatient) care pathway at their usual residence (home or care home).

Study schedule: Enrolment on day 0. Telephone follow up at day 14 day, and day 28. If admitted between randomisation and day 28, data will be collected until hospital discharge.

Intervention: Azithromycin 500 mg orally once daily for 14 days. The first dose will be within 4 hours of randomisation. This is in addition to standard care as per local hospital advice for those patients with suspected COVID who are not admitted: i.e. symptomatic relief with rest, as-required paracetamol (where appropriate) and advice to seek further medical attention if significant worsening of breathlessness.

Comparator: Standard care as per local hospital advice for those patients with suspected COVID who are not admitted: i.e. symptomatic relief with rest, as-required paracetamol (where appropriate) and advice to seek further medical attention if significant worsening of breathlessness.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Open label, Two-arm, Randomised Superiority Trial
Masking: None (Open Label)
Masking Description:
This is an open-label study. However, while the study is in progress, access to tabular results by allocated treatment allocation will not be available to the research team, patients, or members of the Steering Committee (unless the DSMC advises otherwise).
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Drug: Azithromycin Capsule
Azithromycin 500 mg OD PO 14 days
Study Arms  ICMJE
  • Experimental: Azithromycin
    Azithromycin 2x250mg capsules to be taken orally once daily for 14 days. The first dose will be within 4 hours of randomisation. This is in addition to standard care as per local hospital advice for those patients with suspected COVID who are not admitted: i.e. symptomatic relief with rest, as-required paracetamol (where appropriate) and advice to seek further medical attention if significant worsening of breathlessness.
    Intervention: Drug: Azithromycin Capsule
  • No Intervention: Usual standard care
    Standard care as per local hospital advice for those patients with suspected COVID who are not admitted: i.e. symptomatic relief with rest, as-required paracetamol (where appropriate) and advice to seek further medical attention if significant worsening of breathlessness.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 13, 2020
Estimated Primary Completion Date September 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or Female, aged at least 18 years
  • Assessed by the attending clinical team as appropriate for initial ambulatory (outpatient) management
  • A clinical diagnosis of highly-probable COVID-19 infection (diagnosis by the attending clinical team)
  • No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial
  • Able to understand written English (for the information and consent process) and be able to give informed consent

Exclusion Criteria:

  • Known hypersensitivity to any Macrolide including Azithromycin, Ketolide antibiotic, or the excipients including an allergy to soya or peanuts.
  • Known fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase-insufficiency
  • Currently on a Macrolide antibiotic (Clarithromycin, Azithromycin, Erythromycin, Telithromycin, Spiramycin)
  • On any SSRI (Selective Serotonin Reuptake Inhibitor)
  • Elevated cardiac troponin at initial assessment suggestive of significant myocarditis (if clinically the clinical team have felt it appropriate to check the patient's troponin levels)
  • Evidence of QTc prolongation: QTc>480ms
  • Significant electrolyte disturbance (e.g. hypokalaemia K+<3.5 mmol/L)
  • Clinically relevant bradycardia (P<50 bpm), non-sustained ventricular tachycardia or unstable severe cardiac insufficiency
  • Currently on hydroxychloroquine or chloroquine
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lucy Cureton01865 227 374[email protected]
Contact: Timothy SC Hinks, MD PhD+44 (0)1865 220885[email protected]
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04381962
Other Study ID Numbers  ICMJE ATOMIC2
2020-001740-26 ( EudraCT Number )
282892 ( Other Identifier: IRAS )
20/HRA/2105 ( Other Identifier: London-Brent Research Ethics Committee )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Paul Little, MD PhDUniversity of Southampton
PRS Account University of Oxford
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP