Covid-19 Living Data

Trial NCT04416399
Publication Ramakrishnan S, Lancet Respir Med, 2021 (published paper)
Dates: 2020-07-16 to 2020-12-09
Funding: Mixed (Oxford NIHR Biomedical Research Centre; AstraZeneca )
Conflict of interest: Yes

Methods
	RCT Blinding: Unblinded
	Location : Single center / UK Follow-up duration (days): 28
Inclusion criteria	Participant is willing and able to give informed consent for participation in the trial; Male or Female, aged 18 years or above; New onset of symptoms suggestive of COVID-19 e.g. new onset cough and/or fever, and/or loss of smell or taste within 7 or fewer days of participant being seen at visit 1; In the Investigator's opinion, is able and willing to comply with all trial requirements
Exclusion criteria	A known allergy to investigational medicine product (IMP) (budesonide); Any known contraindication to any of the IMPs (budesonide); Patient currently prescribed inhaled or systemic corticosteroids; Recent use, within the previous 7 days of inhaled or systemic corticosteroids; Patient needs hospitalisation at time of study consent; Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial; Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
Interventions
	Treatment Budesonide Two 400 mcg inhalations twice a day for up to 28 days
	Control Standard care ( / ) Definition of Standard care: Usual care was supportive therapy, with the National Health Service (NHS) advising patients with COVID-19 symptoms to take anti-pyretics for symptoms of fever (products containing paracetamol, or nonsteroidal anti-inflammatories such as aspirin and ibuprofen) and honey for symptoms of cough
Participants
	Randomized 146 participants (n₁=73 / n₂= 73)
	Characteristics of participants N=146 Mean age : 44.5 62 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0
Primary outcome
	In the register Emergency department attendance of hospitalisation related to COVID-19 [ Time Frame: Day 1 to day 28 ]
	In the report COVID-19-related Urgent Care visit, Emergency Department assessment or hospitalisation
Documents available	Protocol NR Statistical plan Yes Data-sharing stated Yes
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	*
General comment	No review-specific outcome data extracted. Pending contact with authors. In addition to the published/pre-print article, the trial registry, statistical analysis plan and supplementary appendix were used in data extraction and assessment of risk of bias. The study protocol was not available. The trial was stopped early after independent statistical review concluded that study outcome would not change with further participant enrolment. As a result, the target sample size specified in the registry was not achieved. There were no differences between the trial registration and the article in the intervention and control treatments or the participant inclusion and exclusion criteria. Outcomes listed in the registry were reported, but none were relevant for the COVID-19 NMA. Consequently, no outcome data have been extracted for this study. On 13th of April ,2021, this study was updated based on the published report.