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

Covid-19 Clinical Trial

— HALT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04381364
• Other study ID #: 2020-02183
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 29, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: January 2022
• Source: St Goran's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: January 31, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ciclesonide Inhalation Aerosol
Ciclesonide 320 µg twice daily for 14 days.

Locations

Country	Name	City	State
Sweden	Södra Älvsborg hospital	Borås
Sweden	Danderyd Hospital	Danderyd
Sweden	Halmstad hospital	Halmstad
Sweden	Karlskoga Hospital	Karlskoga
Sweden	Örebro University Hospital	Örebro
Sweden	Östersund hospital	Östersund
Sweden	Capio S:t Görans Hospital	Stockholm
Sweden	Karolinska University Hospital Huddinge	Stockholm
Sweden	Västmanland County Hospital Västerås	Västerås
Sweden	Växsjö Hospital	Växjö
Sweden	Visby Hospital	Visby

Sponsors (4)

Lead Sponsor	Collaborator
Ola Blennow, MD, PhD	Centrallasarettet Västerås, Danderyd Hospital, Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	All cause death	Rate of and time to (in days) death of any cause	30 days after study inclusion
Secondary	Invasive mechanical ventilation	Rate of and time to (in days) received invasive mechanical ventilation	30 days after study inclusion
Secondary	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
Secondary	Need for intensive care	Need for intensive care (yes/no and time to ICU care from inclusion)	30 days after study inclusion
Secondary	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