Covid-19Phase 2HALTNCT04381364
Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)
A Phase 2 study testing Ciclesonide Inhalation Aerosol in people with Covid-19 and Pneumonia, Viral, run by Ola Blennow, MD, PhD at 11 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, Pneumonia, Viral, Sars-CoV2
- What is being tested?
- Ciclesonide Inhalation Aerosol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 11 sitesSweden
- Study dates
- 29 May 2020to 31 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Sweden11 sites
Södra Älvsborg hospital
Borås
Danderyd Hospital
Danderyd
Halmstad hospital
Halmstad
Karlskoga Hospital
Karlskoga
Örebro University Hospital
Örebro
Östersund hospital
Östersund
Capio S:t Görans Hospital
Stockholm
Karolinska University Hospital Huddinge
Stockholm
Västmanland County Hospital Västerås
Västerås
Växsjö Hospital
Vaxjo
Visby Hospital
Visby
About this study
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.
- Conditions
- Covid-19, Pneumonia, Viral, Sars-CoV2
- Being tested
- Ciclesonide Inhalation Aerosol
- Keywords
- Corona virus, Covid-19, Sars-CoV2, Randomized controlled trial, Human, Intervention study, Corticosteroids
- Medical subject headings
- COVID-19, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclesonide Inhalation AerosolDrug
Also called Alvesco
Ciclesonide 320 µg twice daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Medical treatment | Experimental | Treatment with ciclesonide Receives: Drug: Ciclesonide Inhalation Aerosol |
| Standard of Care | No intervention | Standard Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days after study inclusion
Secondary outcomes (6)
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
Measured: 30 days after study inclusion
All cause death
Rate of and time to (in days) death of any cause
Measured: 30 days after study inclusion
Invasive mechanical ventilation
Rate of and time to (in days) received invasive mechanical ventilation
Measured: 30 days after study inclusion
Remaining dyspnea symptoms
Level of remaining dyspnea symptoms according to the Modified Medical Research Council Dyspnea Scale
Measured: 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)
Measured: 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.
Measured: 30 days after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start29 May 2020
- Primary completion1 Aug 2021
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ola Blennow, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Danderyd Hospital, Centrallasarettet Västerås
- Responsible party
- Sponsor-investigator, Ola Blennow, MD, PhD, St Goran's Hospital
- Investigators
- Daniel P Andersson, MD, PhD, Principal investigator, Karolinska University HospitalOla Blennow, MD, PhD, Principal investigator, Capio S:t Görans Hospital and Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381364
- Sponsor's protocol ID
- 2020-02183
- Acronym
- HALT
- Status last verified
- Jan 2022
- First submitted
- 7 May 2020
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36813503
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)
- ClinicalTrials.gov ID
- NCT04381364
- Acronym / sponsor ID
- HALT / 2020-02183
- Conditions
- Covid-19, Pneumonia, Viral, Sars-CoV2
- Keywords
- Corona virus, Covid-19, Sars-CoV2, Randomized controlled trial, Human, Intervention study, Corticosteroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Ola Blennow, MD, PhDUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Danderyd Hospital, Centrallasarettet Västerås
- Study start
- 29 May 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This multicenter study is an open-labelled, randomized clinical trial for 1:1 ratio of ciclesonide or control arm
| Arm | Type | Receives |
|---|---|---|
| Medical treatment | Experimental | Drug: Ciclesonide Inhalation AerosolTreatment with ciclesonide |
| Standard of Care | No intervention | –Standard Medical Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciclesonide Inhalation AerosolAlso: AlvescoCiclesonide 320 µg twice daily for 14 days. | Drug | Medical treatment |
Primary outcome
Duration of received supplemental oxygen therapy
Time frame: 30 days after study inclusion
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).
6 secondary outcomes
Invasive mechanical ventilation or all-cause death (key secondary outcome)
Time frame: 30 days after study inclusion
All cause death
Time frame: 30 days after study inclusion
Invasive mechanical ventilation
Time frame: 30 days after study inclusion
Remaining dyspnea symptoms
Time frame: 30-35 days and 5-7 months after inclusion
Need for intensive care
Time frame: 30 days after study inclusion
Proportion of discharged from the hospital to their home or a nursery home
Time frame: 30 days after study inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Derived from this study: PubMed 36813503Brodin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel P Andersson, MD, PhD principal investigator
Karolinska University Hospital
Ola Blennow, MD, PhD principal investigator
Capio S:t Görans Hospital and Karolinska University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ciclesonide Inhalation Aerosol in people with Covid-19 and Pneumonia, Viral, run by Ola Blennow, MD, PhD at 11 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of received supplemental oxygen therapy (time frame: 30 days after study inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04381364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.