Treatment with inhalation of Ciclesonide for patients with coronavirus disease: A randomised open study.
- Conditions
- Covid-19 pneumoniaTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001928-34-SE
- Lead Sponsor
- Capio S:t Görans Sjukhus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 446
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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?<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): 1. Rate of, and time to need for invasive mechanical ventilation and/or death<br>2. Rate of, and time to death<br>3. Rate of, and time to invasive mechanical ventilation<br>4. Need for intensive care (yes/no and time from inclusion to ICU admission)<br>5. Rate of, and time to discharge from hospital<br>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<br>2. 30 days after inclusion<br>3. 30 days after inclusion<br>4. 30 days after inclusion<br>5. 30 days after inclusion<br>6. 1 month and 5-7 months after inclusion