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

January 18, 2022 updated by: Ola Blennow, MD, PhD
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Borås, Sweden
        • Södra Älvsborg Hospital
      • Danderyd, Sweden
        • Danderyd Hospital
      • Halmstad, Sweden
        • Halmstad Hospital
      • Karlskoga, Sweden
        • Karlskoga Hospital
      • Stockholm, Sweden
        • Capio S:t Görans hospital
      • Stockholm, Sweden
        • Karolinska University Hospital Huddinge
      • Visby, Sweden
        • Visby Hospital
      • Västerås, Sweden
        • Västmanland County Hospital Västerås
      • Växjö, Sweden
        • Växsjö Hospital
      • Örebro, Sweden
        • Örebro University Hospital
      • Östersund, Sweden
        • Östersund hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Medical treatment
Treatment with ciclesonide
Drug: Ciclesonide Inhalation Aerosol
Ciclesonide 320 µg twice daily for 14 days.
Other Names:
  • Alvesco
No Intervention: Standard of Care
Standard Medical Care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
30 days after study inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Invasive mechanical ventilation or all-cause death (key secondary outcome)
Time Frame: 30 days after study inclusion
Rate of and time to (in days) received invasive mechanical ventilation or all-cause death
30 days after study inclusion
All cause death
Time Frame: 30 days after study inclusion
Rate of and time to (in days) death of any cause
30 days after study inclusion
Invasive mechanical ventilation
Time Frame: 30 days after study inclusion
Rate of and time to (in days) received invasive mechanical ventilation
30 days after study inclusion
Remaining dyspnea symptoms
Time Frame: 30-35 days and 5-7 months after inclusion
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
Time Frame: 30 days after study inclusion
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
Time Frame: 30 days after study inclusion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ola Blennow, MD, PhD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karolinska University Hospital
Danderyd Hospital
Centrallasarettet Västerås

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-02183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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