Clinical Trial Results:
Use of inhaled corticosteroids as treatment of early COVID-19 infection to prevent clinical deterioration and hospitalisation
Summary
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EudraCT number |
2020-001889-10 |
Trial protocol |
GB |
Global end of trial date |
04 Dec 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Oct 2022
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First version publication date |
11 Oct 2022
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
STOIC
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04416399 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
University of Oxford
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Sponsor organisation address |
Boundary Brook House, Churchill Drive, Oxford, United Kingdom, OX3 7GB
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Public contact |
Magda Laskawiec-Szkonter, Oxford Respiratory Trials Unit, 44 01865227612, magda.laskawiec@ouh.nhs.uk
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Scientific contact |
Magda Laskawiec-Szkonter, Oxford Respiratory Trials Unit, 44 01865227612, magda.laskawiec@ouh.nhs.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
04 Dec 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
04 Dec 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
04 Dec 2020
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
Evaluate the effect of inhaled corticosteroid (ICS) therapy compared to standard care in participants with early CoVID-19 illness in reducing COVID related emergency department presentations and/or hospital admissions.
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Protection of trial subjects |
Informed consent taken
no invasive techniques conducted
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 146
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Worldwide total number of subjects |
146
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
136
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From 65 to 84 years |
10
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruited from start date of study from the community, within 7 days of symptom onset of COVID-19. Recruited from Oxfordshire UK | |||||||||
Pre-assignment
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Screening details |
Had to be within 7 days of symptoms of COVID-19. 167 participants screened. 146 randomised | |||||||||
Period 1
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Period 1 title |
Study intervention (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Budesonide | |||||||||
Arm description |
Study drug arm | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Budesonide
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
800mcg 2puffs twice a day
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Arm title
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usual care | |||||||||
Arm description |
standard care | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Budesonide
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Reporting group description |
Study drug arm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
usual care
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Reporting group description |
standard care | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
ITT
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Intention to treat
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End points reporting groups
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Reporting group title |
Budesonide
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Reporting group description |
Study drug arm | ||
Reporting group title |
usual care
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Reporting group description |
standard care | ||
Subject analysis set title |
ITT
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Intention to treat
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End point title |
Treatment failure | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 1 to day 28
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Statistical analysis title |
Primary outcome | ||||||||||||
Comparison groups |
Budesonide v usual care
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Number of subjects included in analysis |
146
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.009 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Parameter type |
Risk difference (RD) | ||||||||||||
Point estimate |
0.123
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0.033 | ||||||||||||
upper limit |
0.213 | ||||||||||||
Variability estimate |
Standard error of the mean
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Adverse events information
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Timeframe for reporting adverse events |
Day 1 to day 28
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
SNOMED CT | |||||||||||||||||||||||||||||||||
Dictionary version |
CTV3
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Reporting groups
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Reporting group title |
Budesonide
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
Reporting group title |
Usual care
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/33844996 |