Trial ISRCTN86534580; EudraCT 2020-001209-22
Publication Yu LM, medRxiv, 2021 (preprint)
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
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.|
|Exclusion criteria||Already already taking inhaled or systemic corticosteroids ; unable to use an inhaler ; inhaled budesonide contraindicated.|
800 mcg (2 x 400 mcg inhalations) twice a day for 14 days.
Standard care ( / )
Definition of Standard care: Usual care in the United Kingdom National Health Service for suspected COVID-19 in the community is largely focused on managing symptoms.
2112 participants (n1=1032 / n2= 1080)
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0
|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.
Yes. In English
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
|General comment||In addition to the pre-print article, the trial registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. PRINCIPLE is an adaptive platform trial. The primary outcome was changed from hospitalization or death within 28 days to first instance that a participant reports feeling recovered on the recommendation of the Trial Management Group and Trial Steering and with ethical approval due to low incidence of the original outcome. The Data Monitoring and Safety Committee determined that the pre-specified superiority criterion was met on time to recovery, in both the SARS-CoV-2 positive population and the overall study population. Recruitment was stopped because the Trial Steering Committee decided that accumulating further data to reach pre-specified futility or superiority criteria on hospitalization/death was unlikely due to the successful vaccine rollout and lower than originally anticipated event rate. Therefore the study did not achieve the target sample size specified in the trial registry.|