STerOids in COVID-19 Study

NCT04416399 | Terminated Phase 2

• 1 other identifier: STOIC study
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection

Keywords

CoVID-19; Coronavirus infection; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Emergency department attendance of hospitalisation related to COVID-19

  Evaluate the effect of intervention on emergency department attendance or hospitalisation related to COVID-19

  Day 1 to day 28

Secondary Outcomes (5)

• Body temperature

  Day 1 to day 14

• Blood oxygen saturation level

  Day 1 to day 14

• Symptoms as assessed by common cold questionnaire

  Day 1 to day 14

• Symptoms as assessed by FluPro questionnaire

  Day 1 to day 14

• Nasal/throat swab SARS-CoV-2 viral load

  Day 1, 7 and 14

Study Arms (2)

Inhaled budesonide

EXPERIMENTAL

Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day

Drug: Budesonide dry powder inhaler

Standard of care

NO INTERVENTION

Standard of care

Interventions

Budesonide dry powder inhaler DRUG

Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day

Also known as: Pulmicort

Inhaled budesonide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Oxford Respiratory Trials Unit

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Publications (5)

• Cass SP, Nicolau DV Jr, Baker JR, Mwasuku C, Ramakrishnan S, Mahdi M, Barnes PJ, Donnelly LE, Martinez-Nunez RT, Russell REK, Bafadhel M. Coordinated nasal mucosa-mediated immunity accelerates recovery from COVID-19. ERJ Open Res. 2024 May 13;10(3):00919-2023. doi: 10.1183/23120541.00919-2023. eCollection 2024 May.

  PMID: 38746861 DERIVED

• 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.

  PMID: 35397798 DERIVED

• 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.

  PMID: 33844996 DERIVED

• 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.

  PMID: 33388170 DERIVED

• 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.

  PMID: 32738928 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mona Bafadhel, MBBS, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, open label parallel group controlled clinical trial

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 4, 2020
• Study Start: July 16, 2020
• Primary Completion: January 12, 2021
• Study Completion: January 12, 2021
• Last Updated: February 8, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)