STerOids in COVID-19 Study

Conditions

Coronavirus Infection

Keywords

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

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.

Steven P. Cass, Dan V. Nicolau, Jonathan Baker, Christine Mwasuku, Sanjay Ramakrishnan et al. (11 authors)

ERJ Open Research2024-02-204 citations

10.1183/23120541.00919-2023

Nodal analysis determined nasal mucosal-associated mediators were associated with accelerated clinical recovery from SARS-CoV-2 infection

Steven P. Cass, Jonathan Baker, Christine Mwasuku, Sanjay Ramakrishnan, Mahdi Mahdi et al. (11 authors)

2023-09-09

10.1183/13993003.congress-2023.pa4586

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.

Baker JR, Mahdi M, Nicolau DV, Ramakrishnan S, Barnes PJ, Simpson JL, Cass SP, Russell REK, Donnelly LE, Bafadhel M.

2022-04-0743 citations

10.1016/s2213-2600(22)00002-9

Budesonide: A promising candidate therapeutic for early COVID-19

Shailesh Kumar Patel, Rakesh Kumar, Jigyasa Rana, Aditya Agrawal, Alok Singh et al. (6 authors)

Annals of Medicine and Surgery2021-08-012 citations

10.1016/j.amsu.2021.102605

Inhaled budesonide in the treatment of early COVID-19 (STOIC): a phase 2, open-label, randomised controlled trial.

Ramakrishnan S, Nicolau DV, 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.

2021-04-09287 citations

10.1016/s2213-2600(21)00160-0

PECULIARITIES OF CLINICAL MANAGEMENT OF ASTHMA DURING CORONAVIRUS DISEASE (COVID-19) PANDEMIC

Lyudmyla Konopkina

Ukrainian Pulmonology Journal2021-01-01

10.31215/2306-4927-2021-29-4-44-47

Interventions

DRUGBudesonide dry powder inhaler

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomised, open label parallel group controlled clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Emergency department attendance of hospitalisation related to COVID-19	Day 1 to day 28	Evaluate the effect of intervention on emergency department attendance or hospitalisation related to COVID-19

Secondary

Measure	Time frame	Description
Symptoms as assessed by FluPro questionnaire	Day 1 to day 14	Evaluate the effect of intervention on patient's symptoms as determined by FluPro questionnaire. Higher score meaning worse symptoms.
Nasal/throat swab SARS-CoV-2 viral load	Day 1, 7 and 14	Evaluate the effect of intervention on nasal and throat swab SARS-CoV-2 viral load
Body temperature	Day 1 to day 14	Evaluate the effect of intervention on body temperature
Blood oxygen saturation level	Day 1 to day 14	Evaluate the effect of intervention on blood oxygen level
Symptoms as assessed by common cold questionnaire	Day 1 to day 14	Evaluate the effect of intervention on patient's symptoms as determined by common cold questionnaire. Higher score meaning worse symptoms.

Countries

United Kingdom

Outcome results

None listed