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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pneumonia, Viral; Covid-19; Sars-CoV2
• Intervention / Treatment: Drug: Ciclesonide Inhalation Aerosol

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Borås, Sweden
    • Södra Älvsborg Hospital
  • Danderyd, Sweden
    • Danderyd Hospital
  • Halmstad, Sweden
    • Halmstad Hospital
  • Karlskoga, Sweden
    • Karlskoga Hospital
  • Stockholm, Sweden
    • Capio S:t Görans Hospital
  • Stockholm, Sweden
    • Karolinska University Hospital Huddinge
  • Visby, Sweden
    • Visby Hospital
  • Västerås, Sweden
    • Västmanland County Hospital Västerås
  • Växjö, Sweden
    • Växsjö Hospital
  • Örebro, Sweden
    • Orebro University Hospital
  • Östersund, Sweden
    • Östersund Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical treatment; Treatment with ciclesonide	Drug: Ciclesonide Inhalation Aerosol; Ciclesonide 320 µg twice daily for 14 days.; Other Names: Alvesco
No Intervention: Standard of Care; Standard Medical Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of received supplemental oxygen therapy	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).	30 days after study inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive mechanical ventilation or all-cause death (key secondary outcome)	Rate of and time to (in days) received invasive mechanical ventilation or all-cause death	30 days after study inclusion
All cause death	Rate of and time to (in days) death of any cause	30 days after study inclusion
Invasive mechanical ventilation	Rate of and time to (in days) received invasive mechanical ventilation	30 days after study inclusion
Remaining dyspnea symptoms	Level of remaining dyspnea symptoms according to the Modified Medical Research Council Dyspnea Scale	30-35 days and 5-7 months after inclusion
Need for intensive care	Need for intensive care (yes/no and time to ICU care from inclusion)	30 days after study inclusion
Proportion of discharged from the hospital to their home or a nursery home	Proportion of patients who are discharged from the hospital to their home or a nursery home and time to discharge.	30 days after study inclusion

Collaborators and Investigators

• Sponsor: Ola Blennow, MD, PhD
• 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

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2020
• Primary Completion (Actual): August 1, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Covid-19; Human; Corticosteroids; Sars-CoV2; Intervention study; Corona virus
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; COVID-19; Pneumonia, Viral; Physiological Effects of Drugs; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Allergic Agents; Ciclesonide
• Other Study ID Numbers: 2020-02183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No