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

• ClinicalTrials.gov Identifier: NCT04381364
• Recruitment Status: Active, not recruiting
• First Posted: May 8, 2020
• Last Update Posted: February 2, 2022
• Sponsor: Ola Blennow, MD, PhD
• 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: May 7, 2020
• First Posted Date: May 8, 2020
• Last Update Posted Date: February 2, 2022
• Actual Study Start Date: May 29, 2020
• Actual Primary Completion Date: August 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)
• Official Title: 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: Interventional
• Study Phase: Phase 2

Study Design

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

• Covid-19
• Pneumonia, Viral
• Sars-CoV2

Intervention

Drug: Ciclesonide Inhalation Aerosol

Ciclesonide 320 µg twice daily for 14 days.

Other Name: Alvesco

Study Arms

• Experimental: Medical treatment
  Treatment with ciclesonide
  Intervention: Drug: Ciclesonide Inhalation Aerosol
• No Intervention: Standard of Care
  Standard Medical Care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 18, 2022): 98
• Original Estimated Enrollment (submitted: May 7, 2020): 446
• Estimated Study Completion Date: January 31, 2022
• Actual Primary Completion Date: August 1, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT04381364
• Other Study ID Numbers: 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

• 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: Ola Blennow, MD, PhD
• Original Study Sponsor: Same as current

Collaborators

• Karolinska University Hospital
• Danderyd Hospital
• Centrallasarettet Västerås

Investigators

• 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