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STerOids in COVID-19 Study

NCT04416399 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2021-02-08

No results posted yet for this study

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

Interventions

DRUG

Budesonide dry powder inhaler

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

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Mona Bafadhel, MBBS, PhD · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-16
Primary Completion
2021-01-12
Completion
2021-01-12

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04416399 on ClinicalTrials.gov