Inhalation of Ciclesonide for patients with Covid-19: A randomised open treatment study (HALT Covid-19).

Capio S:t Görans Sjukhus0 个研究点目标入组 446 人开始时间: 2020年4月24日最近更新: 2022年5月16日

试验速览

暂无简介。

•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.

发起方

Capio S:t Görans Sjukhus