Trial ISRCTN86534580
Publication Butler C, Lancet Respir Med, 2021 (published paper)
Dates: 2020-07-24 to 2020-12-14
Funding: Public/non profit (UK Research and Innovation; Department of Health and Social Care; National Institute for Health Research)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / UK Follow-up duration (days): 28 | |
| Inclusion criteria | Living in the community;
aged 65 years or older, or 50 years or older with comorbidities; had ongoing symptoms (for ≤14 days); PCR-confirmed SARS-CoV-2 infection or suspected COVID-19 (in accordance with the UK National Health Service [NHS] definition of high temperature, new continuous cough, or change in sense of smell or taste). Comorbidities required for eligibility in people aged 50–64 years were: weakened immune system; heart disease; hypertension; asthma or lung disease; diabetes; mild hepatic impairment; stroke or neurological problem; self-reported obesity or body-mass index of 35 kg/m² or greater. |
| Exclusion criteria | currently an inpatient in hospital;
almost recovered (general condition much improved and COVID-19 symptoms now mild or almost absent); in the judgement of the recruiting clinician was deemed ineligible; previously been assigned to a group in the PRINCIPLE trial; already taking antibiotics for an acute condition; if doxycycline was contraindicated |
| Interventions | |
| Treatment
Doxycycline Initial dose: 200 mg orally once daily on day 1 Maintenance dose: 100 mg orally once daily for following 6 days |
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| Control
Standard care ( / ) Definition of Standard care: Usual care in the NHS for suspected uncomplicated COVID-19 in the community is largely supportive. Antibiotics are only recommended for suspected COVID-19 pneumonia if bacterial infection is suspected or if the patient is at high risk of adverse outcomes, in which case the guidelines recommend doxycycline | |
| Participants | |
| Randomized 827 participants (n1=827 / n2= *) | |
| Characteristics of participants N=827 Mean age : NR 629 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 Time to first self-reported recovery within 28 days from random assignment; 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 |