Clinical trial NCT04416399: STerOids in COVID-19 Study
Official title: Use of High Dose Inhaled Corticosteroids as Treatment of Early COVID-19 Infection to Prevent Clinical Deterioration and Hospitalisation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Coronavirus Infection
Keywords: CoVID-19
Coronavirus infection
SARS-CoV-2
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, open label parallel group controlled clinical trial
Primary purpose: TREATMENT

Brief summary: At the time of writing (3/4/2020), close to a million people have been infected by the SARS-CoV-2 coronavirus around the world. The severe clinical condition that leads to deaths is now called CoVID-19. Currently, there are no effective treatments for the early or late stages of this illness. Governments worldwide have undertaken dramatic interventions to try and reduce the rate of spread of this deadly coronavirus.

Early data from multiple studies in China, where the virus originated, show that severe cases of CoVID-19 are not as prevalent in patients with chronic lung diseases as expected. This data has been confirmed by the Italian physicians. The investigators think that the widespread use of inhaled corticosteroids reduces the risk of CoVID-19 pneumonia in patients with chronic lung disease. Early microbiological data also shows that these corticosteroids are effective at slowing down the rate of coronavirus replication on lung cells.

Inhaled corticosteroids are widely used to manage common lung conditions, such as asthma. This type of medicine is among the top 3 most common medication prescribed around the world. Their safety is well understood, and their potential side effects are mild and reversible.

The investigators propose to test this idea that, in participants early in the course of CoVID-19 illness, daily high dose inhaled corticosteroids for 28 days, will reduce the chances of severe respiratory illness needing hospitalisation. We will also study the effect of this inhaled therapy on symptoms and viral load.


Eligibility criteria: 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.

Primary outcomes:
measure: Emergency department attendance of hospitalisation related to COVID-19
timeFrame: Day 1 to day 28
Secondary outcomes:
measure: Body temperature
timeFrame: Day 1 to day 14
measure: Blood oxygen saturation level
timeFrame: Day 1 to day 14
measure: Symptoms as assessed by common cold questionnaire
timeFrame: Day 1 to day 14
measure: Symptoms as assessed by FluPro questionnaire
timeFrame: Day 1 to day 14
measure: Nasal/throat swab SARS-CoV-2 viral load
timeFrame: Day 1, 7 and 14
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Respiratory Trials Unit
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Mona Bafadhel, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baker JR, Mahdi M, Nicolau DV Jr, Ramakrishnan S, Barnes PJ, Simpson JL, Cass SP, Russell REK, Donnelly LE, Bafadhel M. Early Th2 inflammation in the upper respiratory mucosa as a predictor of severe COVID-19 and modulation by early treatment with inhaled corticosteroids: a mechanistic analysis. Lancet Respir Med. 2022 Jun;10(6):545-556. doi: 10.1016/S2213-2600(22)00002-9. Epub 2022 Apr 7.
citation: Ramakrishnan S, Nicolau DV Jr, Langford B, Mahdi M, Jeffers H, Mwasuku C, Krassowska K, Fox R, Binnian I, Glover V, Bright S, Butler C, Cane JL, Halner A, Matthews PC, Donnelly LE, Simpson JL, Baker JR, Fadai NT, Peterson S, Bengtsson T, Barnes PJ, Russell REK, Bafadhel M. Inhaled budesonide in the treatment of early COVID-19 (STOIC): a phase 2, open-label, randomised controlled trial. Lancet Respir Med. 2021 Jul;9(7):763-772. doi: 10.1016/S2213-2600(21)00160-0. Epub 2021 Apr 9.
citation: Farne H, Singanayagam A. Reply. J Allergy Clin Immunol. 2021 Mar;147(3):1117-1118. doi: 10.1016/j.jaci.2020.11.019. Epub 2020 Dec 30. No abstract available.
citation: Nicolau DV, Bafadhel M. Inhaled corticosteroids in virus pandemics: a treatment for COVID-19? Lancet Respir Med. 2020 Sep;8(9):846-847. doi: 10.1016/S2213-2600(20)30314-3. Epub 2020 Jul 30. No abstract available.