search
Back to results

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

Primary Purpose

Covid-19, Pneumonia, Viral, Sars-CoV2

Status
Active
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Ciclesonide Inhalation Aerosol
Sponsored by
Ola Blennow, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 focused on measuring Corona virus, Covid-19, Sars-CoV2, Randomized controlled trial, Human, Intervention study, Corticosteroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Medical treatment

Standard of Care

Arm Description

Treatment with ciclesonide

Standard Medical Care

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
All cause death
Rate of and time to (in days) death of any cause
Invasive mechanical ventilation
Rate of and time to (in days) received invasive mechanical ventilation
Remaining dyspnea symptoms
Level of remaining dyspnea symptoms according to the Modified Medical Research Council Dyspnea Scale
Need for intensive care
Need for intensive care (yes/no and time to ICU care from 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.

Full Information

First Posted
May 7, 2020
Last Updated
January 18, 2022
Sponsor
Ola Blennow, MD, PhD
Collaborators
Karolinska University Hospital, Danderyd Hospital, Centrallasarettet Västerås
search

1. Study Identification

Unique Protocol Identification Number
NCT04381364
Brief Title
Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)
Acronym
HALT
Official Title
Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ola Blennow, MD, PhD
Collaborators
Karolinska University Hospital, Danderyd Hospital, Centrallasarettet Västerås

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19, Pneumonia, Viral, Sars-CoV2
Keywords
Corona virus, Covid-19, Sars-CoV2, Randomized controlled trial, Human, Intervention study, Corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical treatment
Arm Type
Experimental
Arm Description
Treatment with ciclesonide
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard Medical Care
Intervention Type
Drug
Intervention Name(s)
Ciclesonide Inhalation Aerosol
Other Intervention Name(s)
Alvesco
Intervention Description
Ciclesonide 320 µg twice daily for 14 days.
Primary Outcome Measure Information:
Title
Duration of received supplemental oxygen therapy
Description
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).
Time Frame
30 days after study inclusion
Secondary Outcome Measure Information:
Title
Invasive mechanical ventilation or all-cause death (key secondary outcome)
Description
Rate of and time to (in days) received invasive mechanical ventilation or all-cause death
Time Frame
30 days after study inclusion
Title
All cause death
Description
Rate of and time to (in days) death of any cause
Time Frame
30 days after study inclusion
Title
Invasive mechanical ventilation
Description
Rate of and time to (in days) received invasive mechanical ventilation
Time Frame
30 days after study inclusion
Title
Remaining dyspnea symptoms
Description
Level of remaining dyspnea symptoms according to the Modified Medical Research Council Dyspnea Scale
Time Frame
30-35 days and 5-7 months after inclusion
Title
Need for intensive care
Description
Need for intensive care (yes/no and time to ICU care from inclusion)
Time Frame
30 days after study inclusion
Title
Proportion of discharged from the hospital to their home or a nursery home
Description
Proportion of patients who are discharged from the hospital to their home or a nursery home and time to discharge.
Time Frame
30 days after study inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel P Andersson, MD, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ola Blennow, MD, PhD
Organizational Affiliation
Capio S:t Görans Hospital and Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Södra Älvsborg hospital
City
Borås
Country
Sweden
Facility Name
Danderyd Hospital
City
Danderyd
Country
Sweden
Facility Name
Halmstad hospital
City
Halmstad
Country
Sweden
Facility Name
Karlskoga Hospital
City
Karlskoga
Country
Sweden
Facility Name
Capio S:t Görans Hospital
City
Stockholm
Country
Sweden
Facility Name
Karolinska University Hospital Huddinge
City
Stockholm
Country
Sweden
Facility Name
Visby Hospital
City
Visby
Country
Sweden
Facility Name
Västmanland County Hospital Västerås
City
Västerås
Country
Sweden
Facility Name
Växsjö Hospital
City
Växjö
Country
Sweden
Facility Name
Örebro University Hospital
City
Örebro
Country
Sweden
Facility Name
Östersund hospital
City
Östersund
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs