Inhaled budesonide
Budesonide dry powder inhaler (Pulmicort Turbuhaler, AstraZeneca) at a dose of 800μg twice a day (400 micrograms per inhalation, 2 inhalations twice a day).
Usual care
Usual care was supportive therapy, with the National Health Service (NHS) advising patients with COVID-19 symptoms to take anti-pyretics for symptoms of fever (products containing paracetamol, or non-steroidal anti-inflammatories such as aspirin and ibuprofen) and honey for symptoms of cough.
COVID 19 outpatients
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.
Open-label.
Single-center, Oxfordshire, United Kingdom.
Phase II. Participants were seen at their homes at randomisation (day 0), day 7 and day 14 by a trained respiratory research nurse. At day 28, all study participants were seen in the trial centre and serum SARS-CoV-2 antibody testing was performed
The trial was stopped early after independent statistical review concluded that study outcome would not change with further participant enrolment.
PRINCIPLE, 2021 ISRCTN86534580
budesonide (n=1073) vs. standard of care (n=1988)
randomized controlled trial
some concerns about risk of bias
inhaled budesonide (800μg twice daily for 14 days) plus usual care
Inhaled budesonide (800μg twice daily for 14 days) plus usual care;
usual care
several arms: usual care, usual care plus budesonide or usual care plus other interventions