Trial ISRCTN86534580 ; EudraCT 2020-001209-22
Publication Butler C, Lancet , 2021 (published paper)
Dates: 2020-05-22 to 2020-11-30
Funding: Public/non profit (UK Research and Innovation and UK Department of Health and Social Care)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
* / UK Follow-up duration (days): 28 | |
| Inclusion criteria | People in the community ; aged 65 years and older, or 50 years and older with comorbidities ; ongoing symptoms from PCR-confirmed or suspected COVID-19 (in accordance with the UK National Health Service [NHS] syndromic case definition of high temperature, a new, continuous cough, or a change in sense of smell or taste) ; Symptoms must have started within the past 14 days ; Comorbidities required for eligibility in those aged 50–65 years were as follows: known weakened immune system due to a serious illness or medication (eg, chemotherapy); known heart disease or a diagnosis of high blood pressure; known asthma or lung disease; known diabetes; known mild hepatic impairment; or known stroke or neurological problems. |
| Exclusion criteria | Already receiving acute antibiotics; contraindication to azithromycin as identified in the summary of product characteristics and British National Formulary |
| Interventions | |
| Treatment
Standard care * |
|
| Control
Azithromycin ( / ) | |
| Participants | |
| Randomized * participants (n1=* / n2= *) | |
| Characteristics of participants N=* Mean age : NR 486 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register 1. Time taken to self-reported recovery, defined as the first instance that a participant reports feeling recovered from possible COVID-19 2. Hospitalisation and/or death | |
| In the report Coprimary endpoints: time to first self-reported recovery within 28 days from random assignment, with time to recovery defined as the first instance that a participant reported feeling recovered; and hospital admission or death within 28 days of random assignment. | |
| 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 |
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| General comment |