A Multicentre Open-label Two-arm Randomised Superiority Clinical Trial of Azithromycin Versus Usual Care In Ambulatory COVID19 (ATOMIC2)
NCT04381962
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- 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
- 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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Descriptive Information | |||||||||
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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
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Condition ICMJE | COVID-19 | ||||||||
Intervention ICMJE | Drug: Azithromycin Capsule
Azithromycin 500 mg OD PO 14 days | ||||||||
Study Arms ICMJE |
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Publications * | Hinks TSC, Barber VS, Black J, Dutton SJ, Jabeen M, Melhorn J, Rahman NM, Richards D, Lasserson D, Pavord ID, Bafadhel M. A multi-centre open-label two-arm randomised superiority clinical trial of azithromycin versus usual care in ambulatory COVID-19: study protocol for the ATOMIC2 trial. Trials. 2020 Aug 17;21(1):718. doi: 10.1186/s13063-020-04593-8. | ||||||||
* 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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | University of Oxford | ||||||||
Study Sponsor ICMJE | University of Oxford | ||||||||
Collaborators ICMJE | Pfizer | ||||||||
Investigators ICMJE |
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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 |