Trial NCT04381962
Publication Hinks T, Lancet Respir Med, 2021 (published paper)
Dates: 2020-06-03 to 2021-01-29
Funding: Mixed (NIHR Oxford BRC, University of Oxford and Pfizer Inc)
Conflict of interest: Yes
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / UK Follow-up duration (days): 28 | |
Inclusion criteria | aged at least 18 years, assessed by the attending clinical team as appropriate for ambulatory (outpatient) management; clincial diagnosis of highly-probably or confirmed COVID-19 infection with onset of first symptoms within the last 14 days; no medical history that might put the patient at significant risk; able to understand written English and 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-isomaltose insufficiency; currently on macrolide antibiotic (Clarithromycin, Azithromycin, Erythromycin, Telithromycin, Spiramycin); Elevated cardiac troponin at initial assessment suggestive of significant myocarditis; evidence of QTc prolongation: QTc>480ms; Significant electrolyte disturbance (e.g. hypokalemia 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 |
Interventions | |
Treatment
Azithromycin 500 mg orally once daily for 14 days |
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Control
Standard care ( / ) Definition of 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. | |
Participants | |
Randomized 295 participants (n1=147 / n2= 148) | |
Characteristics of participants N=295 Mean age : 45.9 152 males Severity : Mild: n=2 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register Proportion progressing to respiratory failure or death (all clinically-diagnosed participants) [ Time Frame: Determined at day 28 from randomisation.] | |
In the report Proportion of participants with hospital admission or death from any cause within 28 days from randomisation | |
Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated
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Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
General comment |