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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381364
Recruitment Status : Active, not recruiting
First Posted : May 8, 2020
Last Update Posted : February 2, 2022
Sponsor:
Collaborators:
Karolinska University Hospital
Danderyd Hospital
Centrallasarettet Västerås
Information provided by (Responsible Party):
Ola Blennow, MD, PhD, St Goran's Hospital

Tracking Information
First Submitted Date  ICMJE May 7, 2020
First Posted Date  ICMJE May 8, 2020
Last Update Posted Date February 2, 2022
Actual Study Start Date  ICMJE May 29, 2020
Actual Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2022)
  • 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
  • All cause death [ Time Frame: 30 days after study inclusion ]
    Rate of and time to (in days) death of any cause
  • Invasive mechanical ventilation [ Time Frame: 30 days after study inclusion ]
    Rate of and time to (in days) received invasive mechanical ventilation
  • 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
  • Need for intensive care [ Time Frame: 30 days after study inclusion ]
    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 [ 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • Invasive mechanical ventilation or all-cause death [ Time Frame: 30 days after study inclusion ]
    Rate of and time to (in days) received invasive mechanical ventilation or all-cause death
  • All cause death [ Time Frame: 30 days after study inclusion ]
    Rate of and time to (in days) death of any cause
  • Invasive mechanical ventilation [ Time Frame: 30 days after study inclusion ]
    Rate of and time to (in days) received invasive mechanical ventilation
  • Maximum oxygen therapy [ Time Frame: 30 days after study inclusion ]
    Maximum received oxygen therapy during hospitalization in liters per minute
  • Duration of hospitalization [ Time Frame: 30 days after study inclusion ]
    Time (in days) from study inclusion to discharge from hospital.
  • Remaining dyspnea symptoms [ Time Frame: 3 and 6 months after inclusion. (Only for patients hospitalized at S:t Goran's Hospital) ]
    Level of remaining dyspnea symptoms according to the Modified Medical Research Council Dyspnea Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)
Official Title  ICMJE Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid-19
  • Pneumonia, Viral
  • Sars-CoV2
Intervention  ICMJE Drug: Ciclesonide Inhalation Aerosol
Ciclesonide 320 µg twice daily for 14 days.
Other Name: Alvesco
Study Arms  ICMJE
  • Experimental: Medical treatment
    Treatment with ciclesonide
    Intervention: Drug: Ciclesonide Inhalation Aerosol
  • No Intervention: Standard of Care
    Standard Medical Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 18, 2022)
98
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
446
Estimated Study Completion Date  ICMJE January 31, 2022
Actual Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04381364
Other Study ID Numbers  ICMJE 2020-02183
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ola Blennow, MD, PhD, St Goran's Hospital
Original Responsible Party Ola Blennow, MD, PhD, St Goran's Hospital, MD, PhD
Current Study Sponsor  ICMJE Ola Blennow, MD, PhD
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Karolinska University Hospital
  • Danderyd Hospital
  • Centrallasarettet Västerås
Investigators  ICMJE
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
PRS Account St Goran's Hospital
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP