Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)
NCT ID: NCT04381364
Last Updated: 2022-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
98 participants
INTERVENTIONAL
2020-05-29
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Medical treatment
Treatment with ciclesonide
Ciclesonide Inhalation Aerosol
Ciclesonide 320 µg twice daily for 14 days.
Standard of Care
Standard Medical Care
No interventions assigned to this group
Interventions
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Ciclesonide Inhalation Aerosol
Ciclesonide 320 µg twice daily for 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Danderyd Hospital
OTHER
Centrallasarettet Västerås
OTHER
Ola Blennow, MD, PhD
OTHER
Responsible Party
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Ola Blennow, MD, PhD
Principal Investigator
Principal Investigators
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Daniel P Andersson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Ola Blennow, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Capio S:t Görans Hospital and Karolinska University Hospital
Locations
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Södra Älvsborg hospital
Borås, , Sweden
Danderyd Hospital
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
Countries
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References
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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.
Other Identifiers
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2020-02183
Identifier Type: -
Identifier Source: org_study_id
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