Covid-19 pneumonia
Conditions
Interventions
Trade Name: Alvesco
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: CICLESONIDE
CAS Number: 141845-82-1
Concentration unit: µg microgram(s)
Concentration type: equal
Concent
Sponsors
Capio S:t Görans Sjukhus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients 18 years or older, who have signed informed consent for participation in the study 2. Hospitalized patients who have received oxygen therapy for maximum 48 hours 3. Verified Covid-19: Positive test for Sars-Cov-2-RNA or a positive Sars-Cov2 antigen test from upper respiratory tract 4. Receives oxygen therapy 5. Negative pregnancy test (female subjects of childbearing potential) 6. Female subjects of childbearing potential must use contraceptive method categorized as "highly effective" according to CTFG during study treatment and 7 days after finished treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 178 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 268
Exclusion criteria
Exclusion criteria: 1. Pregnancy, breast feeding or plans for pregnancy. 2. Known intolerance or hypersensitivity to ciclesonide or any of the other components of the study drug 3. Concomitant treatment with cortisone, ketoconazole, itraconazole, ritonavir or nelfinavir 4. Therapy with >8 L oxygen/min or therapy with >50 % oxygen through high flow nasal cannula 5. Ongoing palliative treatment or life expectancy less than 72 hours 6. Expected admission to ICU within 48 hours 7. Active or inactive tuberculosis 8. Severe liver disease (Child-Pugh C) 9. Pulmonary arterial hypertension (PAH) or fibrosis 10. Mental incapacity, unwillingness or language difficulties 11. Participation in another clinical trial within 30 days before inclusion in the present study. Earlier participation in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Can inhalation treatment with ciclesonide decrease the number of days with oxygen therapy for hospitalized patients with Covid-19?;Secondary Objective: - Can inhalation treatment with ciclesonide decrease the risk for intubation and/or death within 30 days? - Can inhalation treatment with ciclesonide decrease respiratory symptoms after 1 month and 5-7 months?;Primary end point(s): Number of days with oxygen therapy (30 days follow up after study inclusion). Terminated oxygen therapy is defined as discharge from hospital, without subsequent rehospitalization with oxygen therapy within 2 days, or at least 2 days without oxygen therapy for hospitalized patients.;Timepoint(s) of evaluation of this end point: 30 days after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Rate of, and time to need for invasive mechanical ventilation and/or death 2. Rate of, and time to death 3. Rate of, and time to invasive mechanical ventilation 4. Need for intensive care (yes/no and time from inclusion to ICU admission) 5. Rate of, and time to discharge from hospital 6. Number of subjects with residual respiratory symptoms measured with the Modified Medical Research Council Dyspnea scale;Timepoint(s) of evaluation of this end point: 1. 30 days after inclusion 2. 30 days after inclusion 3. 30 days after inclusion 4. 30 days after inclusion 5. 30 days after inclusion 6. 1 month and 5-7 months after inclusion | — |
Countries
Sweden
Contacts
Public ContactGunilla Wahlström
Capio S:t Görans Sjukhus
Outcome results
None listed