NCT04381364.

Study name	Inhalation of ciclesonide for patients with COVID‐19: a randomised open treatment study (HALT COVID‐19)
Methods	Trial design: randomised, multicentre, open‐label Sample size: 446 Setting: inpatient Language: English Number of centres: 6 centres recruiting Type of intervention: treatment
Participants	Inclusion criteria: aged ≥ 18 year who are willing and able to provide written informed consent laboratory‐confirmed (PCR‐positive) SARS‐CoV‐2 infection receiving supplemental oxygen therapy with start < 48 hours before inclusion negative pregnancy test (women of fertile age) agreeing to take highly effective contraceptive measures according to Clinical Trial Facilitation Group criteria during the duration of treatment plus 7 days (women of fertile age) Exclusion criteria: pregnant or breastfeeding women history of hypersensitivity to ciclesonide or other substances included in the treatment ongoing use of corticosteroids, ketoconazole, itraconazole, ritonavir, or nelfinavir receiving oxygen > 8 L/minute or > 50% oxygen with nasal high flow therapy ongoing or planned palliative care or an expected survival of < 72 hours expected admission to intensive care unit within 48 hours active or inactive pulmonary tuberculosis severe liver failure (Child‐Pugh C) pulmonary arterial hypertension or fibrosis cognitive or physical impairment or insufficient language skills which precludes understanding of information given about the study participation in a clinical trial within past 30 days
Interventions	Intervention group: inhaled ciclesonide 320 µg twice daily for 14 days Control group: standard care Concomitant therapy: no
Outcomes	Primary outcome: duration of received supplemental oxygen therapy 30 days after study inclusion Secondary outcome: invasive mechanical ventilation or all‐cause death (key secondary outcome) 30 days after study inclusion; all‐cause mortality 30 days after study inclusion; invasive mechanical ventilation 30 days after study inclusion; remaining dyspnoea symptoms at 30–35 days and 5–7 months after inclusion
Starting date	29 May 2020
Contact information	Daniel Brodin, MD; +46736313527; daniel.brodin@capiostgoran.se Daniel P Andersson, MD, PhD; +46704490004; daniel.p.andersson@ki.se
Notes	Recruitment status: recruiting Prospective completion date: 1 December 2021 Date last update was posted: 10 May 2021 Sponsor/funding: Ola Blennow, St Goran's Hospital, Stockholm, Sweden