Trial ISRCTN86534580; EudraCT 2020-001209-22
Publication Yu LM, Lancet, 2021 (published paper)
Dates: 2020-11-27 to 2021-03-31
Funding: Public/non profit (UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research)
Conflict of interest: Yes
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / UK Follow-up duration (days): 28 | |
Inclusion criteria | People in the community ; aged ≥65 years, or ≥50 years with comorbidities ; ongoing symptoms from polymerase chain reaction (PCR) confirmed or suspected COVID-19 (in accordance with the United Kingdom National Health Service definition of high temperature and/or new, continuous cough and/or change in sense of smell/taste) which started within the past 14 days; Comorbidities required for eligibility in those aged 50–65 years were heart disease, hypertension, asthma or lung disease, diabetes, hepatic impairment, stroke or neurological problems, weakened immune system (eg, receiving chemotherapy), and self-reported obesity or body-mass index of at least 35 kg/m² |
Exclusion criteria | Already already taking inhaled or systemic corticosteroids ; unable to use an inhaler ; inhaled budesonide contraindicated. |
Interventions | |
Treatment
Budesonide 800 mcg (2 x 400 mcg inhalations) twice a day for 14 days. |
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Control
Standard care ( / ) Definition of Standard care: Usual care in the UK National Health Service for suspected COVID-19 in the community is largely focused on managing symptoms with antipyretics, with antibiotics only recommended if bacterial pneumonia is suspected. | |
Participants | |
Randomized 1073 participants (n1=1073 / n2= *) | |
Characteristics of participants N=1073 Mean age : NR 835 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. Both collected within 28 days of randomization (ISRCTN). | |
In the report 1) Time to first reported recovery defined as the first instance that a participant reports feeling recovered; and 2) Hospitalization or death related to COVID-19. | |
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 |