STerOids in COVID-19 Study (STOIC)

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University of Oxford

Status and phase

Terminated
Phase 2

Conditions

Coronavirus Infection

Treatments

Drug: Budesonide dry powder inhaler

Study type

Interventional

Funder types

Other

Identifiers

NCT04416399
STOIC study

Details and patient eligibility

About

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.

Enrollment

146 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

146 participants in 2 patient groups

Inhaled budesonide
Experimental group
Description:
Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day
Treatment:
Drug: Budesonide dry powder inhaler
Standard of care
No Intervention group
Description:
Standard of care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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