Inhaled steroids in the early treatment of COVID-19

A new research paper A new research paper has been recently published in the Lancet. Entitled “Inhaled budesonide in the early treatment of early COVID-19 (STOIC): a phase 2, open-label, randomised control trial” by S Ramakrishnan et al it looks at the use of a steroid inhaler in early COVID-19 infections.

STOIC stands for Steroids in COVID-19.

Why did they do the study?

Multiple early reports of patients admitted to hospital with COVID-19 showed that patients with chronic respiratory disease (such as severe asthma, Chronic Obstructive Pulmonary Disease) were significantly under-represented considering SARS-COV-2 was initially thought to be a respiratory disease. These patients should be amongst the sickest. The team hypothesised that the widespread use of inhaled steroids among these patients was responsible for this finding. They therefore went on to test if inhaled steroids would be an effective treatment for early COVID-19.

What did they do?

They performed an open-label, parallel-group, phase 2, randomised controlled trial of inhaled budesonide, compared with usual care, in adults within 7 days of the onset of mild COVID-19 symptoms. The trial was done in the community in Oxfordshire, UK. Participants were randomly assigned to inhaled budsonide or usual care stratified for age (≤40 years or >40 years), sex (male or female), and number of comorbidities (≤1 and ≥2). Budesonide dry powder was delivered using a turbohaler at a dose of 800 μg per actuation (puff).

Participants were asked to take two puffs twice a day until symptom resolution.

What was the primary outcome measured?

The primary endpoint was COVID-19-related urgent care visit including emergency department assessment or hospitalisation.

What were the secondary outcomes measured?

The secondary outcomes were:

  • Self-reported clinical recovery (symptom resolution). Viral symptoms measured using the Common Cold Questionnare (CCQ) and the InFLUenza Patient Reported Outcome Questionnaire (FLUPro)

  • Body temperature

  • Blood oxygen saturations

  • SARS-CoV-2 viral load.

The trial was stopped early after independent statistical review concluded that study outcome would not change with further participant enrolment. IE they found that budesonide was making a clinical difference.

What did they find?

From July 16 to Dec 9, 2020, 167 participants were recruited and assessed for eligibility. 21 did not meet eligibility criteria and were excluded. 146 participants were randomly assigned—73 to usual care and 73 to budesonide.

  1. The primary outcome, attending the emergency department or hospitalisation, occurred in 15% of patients in the usual care group compared to 3% in the budesonide group. This is 5 times more likely.

  2. From this the team worked out that the number needed to treat with inhaled budesonide to reduce COVID-19 deterioration was eight.

  3. They also found that clinical recovery was 1 day shorter in the budesonide group compared with the usual care group. The average recovery being 7 days.

  4. The mean proportion of days with a fever in the first 14 days was lower in the budesonide group than the usual care group and the proportion of participants with at least 1 day of fever was lower in the budesonide group when compared with the usual care group. As-needed antipyretic medication was required for fewer proportion of days in the budesonide group compared with the usual care group

  5. Fewer participants randomly assigned to budesonide had persistent symptoms at days 14 and 28 compared with participants receiving usual care. ??Long Covid relevance??

  6. The mean total score change in the CCQ and FLUPro over 14 days was significantly better in the budesonide group compared with the usual care group

  7. Blood oxygen saturations and SARS-CoV-2 load, measured by cycle threshold, were not different between the groups.

  8. Budesonide was safe, with only five (7%) participants reporting self-limiting adverse events.

What was the study's take home message?

Early administration of inhaled budesonide reduced the likelihood of needing urgent medical care and reduced time to recovery after early COVID-19.

Of course it will be interesting to see if this trial is continued to see which of these patients went on to develop Long Covid and whether those who had budesonide have a milder or shorter recovery course - especially with regards to inflammatory processes like myocarditis, pericarditis and neuropathies. Interestingly I was offered a short course of prednisolone ( a steroid) at about week four of my acute Covid. I refused it as I was still spiking very high temperatures and felt I was still teeming with virus. Steroids are commonly used, in the tablet form so higher strength, as an immune suppressant and are used for many autoimmune diseases to help with symptoms but they also dampen down the bodies natural immune response and can make infections significantly worse. Only research will tell if I made the wrong decision.

I do wonder though if those of us with LC how many of us would be feeling significantly better if we had been started on steroids, or something similar, a few months into our illness?

Recent medical headlines

'Case-by-case' approach to GPs prescribing budesonide for COVID-19

Inhaled budesonide is not expected to be routinely prescribed for patients receiving treatment in the community for COVID-19 but can be considered 'case-by-case' by GPs, NHS officials have said.


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