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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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 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
Actual Primary Completion Date : August 1, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ciclesonide

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 (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. Need for intensive care [ Time Frame: 30 days after study inclusion ]
    Need for intensive care (yes/no and time to ICU care from inclusion)

  6. 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.



Information from the National Library of Medicine

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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:

  • 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.

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


Locations
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Sweden
Södra Älvsborg hospital
Borås, Sweden
Danderyd Hospital
Danderyd, Sweden
Halmstad hospital
Halmstad, Sweden
Karlskoga Hospital
Karlskoga, Sweden
Capio S:t Görans Hospital
Stockholm, Sweden
Karolinska University Hospital Huddinge
Stockholm, Sweden
Visby Hospital
Visby, Sweden
Västmanland County Hospital Västerås
Västerås, Sweden
Växsjö Hospital
Växjö, Sweden
Örebro University Hospital
Örebro, Sweden
Östersund hospital
Östersund, Sweden
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: February 2, 2022
Last Verified: January 2022
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