Randomized open label clinical trial carried out at study centers in Sweden, including Karolinska University Hospital, S:t Göran Hospital, Danderyd Hospital and Västmanlands Hospital. Patients with COVID-19 who are hospitalized with oxygen therapy are eligible for inclusion. Subjects are randomized to 14 days of inhalation with ciclesonide 360 µg twice daily or to standard of care. Primary outcome is duration of received supplemental oxygen therapy. Key secondary outcome is a composite outcome of death and received invasive mechanical ventilation within 30 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Ciclesonide 320 µg twice daily for 14 days.
Södra Älvsborg hospital
Borås, Sweden
Danderyd Hospital
Danderyd, Sweden
Halmstad hospital
Halmstad, Sweden
Karlskoga Hospital
Karlskoga, Sweden
Örebro University Hospital
Örebro, Sweden
Östersund hospital
Östersund, Sweden
Capio S:t Görans Hospital
Stockholm, Sweden
Karolinska University Hospital Huddinge
Stockholm, Sweden
Växsjö Hospital
Vaxjo, Sweden
Västmanland County Hospital Västerås
Västerås, Sweden
...and 1 more locations
Duration of received supplemental oxygen therapy
Time (in days) of received supplemental oxygen therapy (defined as being alive and discharged from hospital to home or at least 48 h of not receiving oxygen therapy during hospitalization).
Time frame: 30 days after study inclusion
Invasive mechanical ventilation or all-cause death (key secondary outcome)
Rate of and time to (in days) received invasive mechanical ventilation or all-cause death
Time frame: 30 days after study inclusion
All cause death
Rate of and time to (in days) death of any cause
Time frame: 30 days after study inclusion
Invasive mechanical ventilation
Rate of and time to (in days) received invasive mechanical ventilation
Time frame: 30 days after study inclusion
Remaining dyspnea symptoms
Level of remaining dyspnea symptoms according to the Modified Medical Research Council Dyspnea Scale
Time frame: 30-35 days and 5-7 months after inclusion
Need for intensive care
Need for intensive care (yes/no and time to ICU care from inclusion)
Time frame: 30 days after study inclusion
Proportion of discharged from the hospital to their home or a nursery home
Proportion of patients who are discharged from the hospital to their home or a nursery home and time to discharge.
Time frame: 30 days after study inclusion
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