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

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ClinicalTrials.gov Identifier: NCT04381364
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : May 10, 2021
Sponsor:
Collaborators:
Karolinska University Hospital
Danderyd Hospital
Centrallasarettet Västerås
Information provided by (Responsible Party):
Ola Blennow, MD, PhD, St Goran's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid-19 Pneumonia, Viral Sars-CoV2 Drug: Ciclesonide Inhalation Aerosol Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 446 participants
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
Official Title: Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)
Actual Study Start Date : May 29, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ciclesonide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Medical treatment
Treatment with ciclesonide
 Drug: Ciclesonide Inhalation Aerosol
Ciclesonide 320 µg twice daily for 14 days.
Other Name: Alvesco
No Intervention: Standard of Care
Standard Medical Care


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. Treatment with systemic corticosteroids [ Time Frame: 14 days after study inclusion ]
    Rate of patients receiving treatment with systemic corticosteroids


Secondary Outcome Measures :
  1. 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

  2. All cause death [ Time Frame: 30 days after study inclusion ]
    Rate of and time to (in days) death of any cause

  3. Invasive mechanical ventilation [ Time Frame: 30 days after study inclusion ]
    Rate of and time to (in days) received invasive mechanical ventilation

  4. 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

  5. Time from inclusion to initiation of treatment with systemic corticosteroids [ Time Frame: 14 days after study inclusion ]
    Days from inclusion to initiation of treatment with systemic corticosteroids


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 18 or older who are willing and able to provide written informed consent.
  2. Laboratory-confirmed (PCR-positive) SARS-CoV-2 infection.
  3. Receiving supplemental oxygen therapy with start <48 hours before inclusion.
  4. Negative pregnancy test (women in fertile age).
  5. Agreeing to take highly effective contraceptive measures according to Clinical Trial Facilitation Group criteria during the duration of treatment plus 7 days (women in fertile age).

Exclusion Criteria:

  1. Pregnant or breastfeeding women.
  2. History of hypersensitivity to ciclesonide or other substances included in the treatment.
  3. Ongoing use of corticosteroids, ketokonazol, itrakonazol, ritonavir or nelfinavir.
  4. Receiving >8 l oxygen/min or >50 % oxygen with nasal high flow therapy.
  5. Ongoing or planned palliative care or an expected survival of less than 72 h.
  6. Expected admission to intensive care unit within 48 h.
  7. Active or inactive pulmonary tuberculosis.
  8. Severe liver failure (Child-Pugh C)
  9. Pulmonary arterial hypertension (PAH) or fibrosis.
  10. Cognitive or physical impairment or insufficient language skills which precludes understanding of information given about the study.
  11. Participation in a clinical trial within the past 30 days.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381364


Contacts
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Contact: Daniel Brodin, MD +46736313527 daniel.brodin@capiostgoran.se
Contact: Daniel P Andersson, MD, PhD +46704490004 daniel.p.andersson@ki.se

Locations
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Sweden
Danderyd Hospital Recruiting
Danderyd, Sweden
Contact: Eli Westerlund, MD, PhD         
Capio S:t Görans Hospital Recruiting
Stockholm, Sweden
Contact: Daniel Brodin, MD       daniel.brodin@capiostgoran.se   
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Daniel P Andersson, MD, PhD       daniel.p.andersson@ki.se   
Visby Hospital Recruiting
Visby, Sweden
Contact: Jonas Lindell, MD         
Västmanland County Hospital Västerås Recruiting
Västerås, Sweden
Contact: Anders Krifors, MD       anders.krifors@regionvastmanland.se   
Örebro University Hospital Recruiting
Örebro, Sweden
Contact: Simon Athlin, MD, PhD         
Sponsors and Collaborators
Ola Blennow, MD, PhD
Karolinska University Hospital
Danderyd Hospital
Centrallasarettet Västerås
Investigators
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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
More Information
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Responsible Party: Ola Blennow, MD, PhD, Principal Investigator, St Goran's Hospital
ClinicalTrials.gov Identifier: NCT04381364    
Other Study ID Numbers: 2020-02183
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ola Blennow, MD, PhD, St Goran's Hospital:
Corona virus
Covid-19
Sars-CoV2
Randomized controlled trial
 Human
Intervention study
Corticosteroids
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Respiratory Tract Infections
Infections
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents