CTRI/2020/10/028581.

Study name	Clinical trial to study the effect of budesonide taken through inhalation in mild COVID cases
Methods	Trial design: randomised, parallel‐group, controlled trial Sample size: 1000 Setting: outpatient Language: English Number of centres: 4 Type of intervention: treatment
Participants	Inclusion criteria: people with RT‐PCR or rapid antigen confirmed diagnosis of COVID‐19 asymptomatic person with mild symptoms of < 5 days of duration oxygen saturation > 94% on room air no radiological evidence of pneumonia aged > 18 years to 99 years Exclusion criteria: requiring hospitalisation unable to take the drug as directed and comply with study procedure vulnerable population (pregnant women, lactating women, Prisoners, unable to consent) receiving systemic/inhalational steroids
Interventions	Intervention group: inhaled Rotacaps or Dry powder inhalation of budesonide 200 μg twice daily + standard care for 10–14 days depending on onset of symptoms Control group: standard care for mild COVID‐19 cases as provided by the centre Concomitant therapy: no
Outcomes	Primary outcome: hospitalisation with time points of 10–14 days depending on the onset of symptoms Secondary outcomes: none
Starting date	23 October 2020
Contact information	Dr Tushar Patel SPARSH Chest Disease Centre, 100B Swastik Society, Opposite Samved Hospital, Navrangpura, Ahmedabad Respiratory Medicine Department, GCS Hospital, Near Chamunda Bridge, Naroda road, Ahmedabad 380025 Ahmadabad GUJARAT 380009 India drtusharpatel@yahoo.com
Notes	Recruitment status: not yet recruiting Prospective completion date: not reported Date last update was posted: 23 October 2020 Sponsor/funding: Dr Tushar Patel, SPARSH Chest Disease Centre, 100B Swastik Society, Opposite Samved Hospital, Navrangpura, Ahmedabad