Trial NCT04416399
Publication STOIC - 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

Participants
Randomized
participants :
Budesonide=73
Standard care =73
Characteristics of participants
N= 146
Mean age : NR
62 males
Severity : Mild: n= 146/ Asymptomatic: n=0
Number of vaccinated participants: NR
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 willing stated in the publication:

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.