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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381364
Recruitment Status : Not yet recruiting
First Posted : May 8, 2020
Last Update Posted : May 12, 2020
Sponsor:
Collaborators:
Karolinska University Hospital
Danderyd Hospital
Centrallasarettet Västerås
Information provided by (Responsible Party):
Ola Blennow, MD, PhD, St Goran's Hospital

Brief Summary:
Randomized open label clinical trial carried out at study centers in Sweden, including Karolinska University Hospital Huddinge, 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 time (in days) 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 ARDS ARDS, Human Sars-CoV2 Coronavirus Infection Corona Virus Infection Drug: Ciclesonide Inhalation Aerosol Phase 2

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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)
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 31, 2020


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



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).


Secondary Outcome Measures :
  1. 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

  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. Maximum oxygen therapy [ Time Frame: 30 days after study inclusion ]
    Maximum received oxygen therapy during hospitalization in liters per minute

  5. Duration of hospitalization [ Time Frame: 30 days after study inclusion ]
    Time (in days) from study inclusion to discharge from hospital.

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 to 85 years of age that are hospitalized and require oxygen therapy.
  • Lab-confirmed (PCR-positive) SARS-CoV-2 infection within <48 h of study enrollment or a clinical diagnosis of COVID-19 by the treating physician based on symptoms and radiological findings within <48 h of study enrollment.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Patients requiring ≥8 L supplemental oxygen at admission or receiving >50% oxygen with nasal high flow therapy.
  • Patients who are hospitalized for palliative care or who have an expected survival of less than 72 h.
  • Patients with cognitive or physical impairment or insufficient language skills which precludes either self-administration of the intervention drug or understanding information given about the study.
  • Ongoing use of corticosteroids, ketokonazol, itrakonazol, ritonavir or nelfinavir.
  • Pregnant or breastfeeding women.
  • Women in child-bearing age not using adequate contraceptive methods
  • History of hypersensitivity to ciclesonide or other substances included in the treatment.
  • Participation in a clinical trial within the past 30 days.

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
Danderyd, Entrévägen 2, Sweden, 18257
Contact: Magnus Bager, MD    +46812358068    magnus.bager@sll.se   
Capio S:t Görans Hospital
Stockholm, Sankt Göransplan 1, Sweden, 11281
Contact: Daniel Brodin, MD    +46736313527    daniel.brodin@capiostgoran.se   
Västmanland County Hospital Västerås
Västerås, Sigtunagatan, Sweden, 72189
Contact: Anders Krifors, MD       anders.krifors@regionvastmanland.se   
Karolinska University Hospital
Stockholm, Sweden, 14186
Contact: Daniel P Andersson, MD, PhD       daniel.p.andersson@ki.se   
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
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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 12, 2020
Last Verified: May 2020
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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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia, Viral
Pneumonia
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents