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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| Danderyd Hospital | OTHER |
| Centrallasarettet Västerås | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical treatment | Experimental | Treatment with ciclesonide |
|
| Standard of Care | No Intervention | Standard Medical Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide Inhalation Aerosol | Drug | Ciclesonide 320 µg twice daily for 14 days. |
|
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel P Andersson, MD, PhD | Karolinska University Hospital | Principal Investigator |
| Ola Blennow, MD, PhD | Capio S:t Görans Hospital and Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södra Älvsborg hospital | Borås | Sweden | ||||
| Danderyd Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36813503 | Derived | Brodin D, Tornhammar P, Ueda P, Krifors A, Westerlund E, Athlin S, Wojt S, Elvstam O, Neumann A, Elshani A, Giesecke J, Edvardsson-Kallkvist J, Bunpuckdee S, Unge C, Larsson M, Johansson B, Ljungberg J, Lindell J, Hansson J, Blennow O, Andersson DP. Inhaled ciclesonide in adults hospitalised with COVID-19: a randomised controlled open-label trial (HALT COVID-19). BMJ Open. 2023 Feb 22;13(2):e064374. doi: 10.1136/bmjopen-2022-064374. |
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This multicenter study is an open-labelled, randomized clinical trial for 1:1 ratio of ciclesonide or control arm
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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 |
| 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 |
| Visby Hospital | Visby | Sweden |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C120481 | ciclesonide |
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