The desperation of clinicians when faced with COVID-19 and the dearth of therapeutic options for its treatment have led clinical practice to reach for last-resort approaches, supported by tenuous data or hypotheses.
The need for data-based clinical practice is clear from the initial wide use of hydroxychloroquine, shown subsequently to be harmful,1, 2 and the initial avoidance of oral corticosteroids, shown subsequently to be beneficial.3
Now practice is changing toward the usual measured approach of gathering data and using restraint, trying above all to do no harm in this viral illness.
Platforms for remarkable well designed pragmatic pandemic research, such as PRINCIPLE and the earlier RECOVERY study platform, have emerged to inform practice. The focus of the PRINCIPLE adaptive trial platform on management of COVID-19 in the primary care setting is vital—less than 10% of patients are managed in hospital.
Compared to Monoclonal Antibody treatment (e.g. (REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19. N Engl J Med. 2021 Jan 21;384(3):238-251. https://
Two studies (with slightly different populations and slightly different outcomes) showed benefit for patients with Covid NOT in hospital.
For adults with Covid, inhaled budesonide 800 mcg BID started after ~ 3d of symptoms reduced UC & ED visits and hospitalizations (3% vs 15%) and shortened average recovery (8 vs 12 days) [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. https://pubmed.ncbi.nlm.nih.gov/33844996/
For higher risk adults with Covid, inhaled budesonide 800 mcg BID started after ~ 6 days of symptoms may not have reduced hospitalization or death (6.8% vs 8.8%), but shortened time to recovery by ~ 3 days (11.8 vs 14.7). [Inhaled budesonide for COVID-19 in people at high risk of complications in the community in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial.
Lancet. 2021 Sep 4;398(10303):843-855. doi: 10.1016/S0140-6736(21)01744-X.