Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)

Study Overview
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Brief Summary
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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.

Official Title
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Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)

Conditions
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Covid-19, Pneumonia, Viral, Sars-CoV2

Intervention / Treatment
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* Drug: Ciclesonide Inhalation Aerosol


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients 18 years of age or older who have given their written consent to participate in the study. Hospitalized and treated with oxygen for a maximum of 48 hours. Verified Covid-19: Positive sample for Sars-Cov2 RNA or a positive Sars-Cov2 antigen test from the upper respiratory tract Receives oxygen treatment. Negative pregnancy test (women of childbearing potential) Willing to exercise contraception categorized as very effective according to the Clinical Trial Facilitation Group during ongoing study treatment + 7 days (Appendix 2). (female research participant of childbearing potential) Exclusion criteria: Pregnancy, breast-feeding or planned pregnancy. Hypersensitivity to ciclesonide or to any of the excipients. Concomitant medication with cortisone, ketoconazole, itraconazole, ritonavir or nelfinavir. Treatment with> 8 l oxygen / min or supply of > 50% oxygen with nasal high-flow cannula Ongoing palliative care or expected survival of less than 72 hours. Expected admission to the intensive care unit within 48 hours. Active or inactive pulmonary tuberculosis. Severe Liver Failure (Child-Pugh C) Diagnosed with pulmonary arterial hypertension (PAH) or fibrosis. Mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study. Participates in or has recently participated in a clinical trial in the last 30 days. Previous participation in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This multicenter study is an open-labelled, randomized clinical trial for 1:1 ratio of ciclesonide or control arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical treatment<br>Treatment with ciclesonide | Drug: Ciclesonide Inhalation Aerosol<br>* Ciclesonide 320 µg twice daily for 14 days.<br>* Other names: Alvesco;|
| No Intervention: Standard of Care<br>Standard Medical Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 30 days after study inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days after study inclusion | 
| All cause death | Rate of and time to (in days) death of any cause | 30 days after study inclusion | 
| Invasive mechanical ventilation | Rate of and time to (in days) received invasive mechanical ventilation | 30 days after study inclusion | 
| Remaining dyspnea symptoms | Level of remaining dyspnea symptoms according to the Modified Medical Research Council Dyspnea Scale | 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) | 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. | 30 days after study inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corona virus, Covid-19, Sars-CoV2, Randomized controlled trial, Human, Intervention study, Corticosteroids