Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)
HALT
1 other identifier
interventional
98
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 covid19
Started May 2020
Longer than P75 for phase_2 covid19
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2020
CompletedFirst Posted
Study publicly available on registry
May 8, 2020
CompletedStudy Start
First participant enrolled
May 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedFebruary 2, 2022
January 1, 2022
1.2 years
May 7, 2020
January 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Invasive mechanical ventilation or all-cause death (key secondary outcome)
30 days after study inclusion
All cause death
30 days after study inclusion
Invasive mechanical ventilation
30 days after study inclusion
Remaining dyspnea symptoms
30-35 days and 5-7 months after inclusion
Need for intensive care
30 days after study inclusion
- +1 more secondary outcomes
Study Arms (2)
Medical treatment
EXPERIMENTALTreatment with ciclesonide
Standard of Care
NO INTERVENTIONStandard Medical Care
Interventions
Ciclesonide 320 µg twice daily for 14 days.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ola Blennow, MD, PhDlead
- Karolinska University Hospitalcollaborator
- Danderyd Hospitalcollaborator
- Centrallasarettet Västeråscollaborator
Study Sites (11)
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
Related Publications (1)
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.
PMID: 36813503DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel P Andersson, MD, PhD
Karolinska University Hospital
- PRINCIPAL INVESTIGATOR
Ola Blennow, MD, PhD
Capio S:t Görans Hospital and Karolinska University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 7, 2020
First Posted
May 8, 2020
Study Start
May 29, 2020
Primary Completion
August 1, 2021
Study Completion
January 31, 2022
Last Updated
February 2, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share