Clinical trial NCT04381364: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Covid-19
Pneumonia, Viral
Sars-CoV2
Keywords: Corona virus
Covid-19
Sars-CoV2
Randomized controlled trial
Human
Intervention study
Corticosteroids
Lead sponsor: St Goran's Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Danderyd Hospital
name: Centrallasarettet Västerås
First posted: 2020-05-08
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This multicenter study is an open-labelled, randomized clinical trial for 1:1 ratio of ciclesonide or control arm
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Duration of received supplemental oxygen therapy
timeFrame: 30 days after study inclusion
Secondary outcomes:
measure: Invasive mechanical ventilation or all-cause death (key secondary outcome)
timeFrame: 30 days after study inclusion
measure: All cause death
timeFrame: 30 days after study inclusion
measure: Invasive mechanical ventilation
timeFrame: 30 days after study inclusion
measure: Remaining dyspnea symptoms
timeFrame: 30-35 days and 5-7 months after inclusion
measure: Need for intensive care
timeFrame: 30 days after study inclusion
measure: Proportion of discharged from the hospital to their home or a nursery home
timeFrame: 30 days after study inclusion
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: Södra Älvsborg hospital
city: Danderyd
country: Sweden
facility: Danderyd Hospital
city: Halmstad
country: Sweden
facility: Halmstad hospital
city: Karlskoga
country: Sweden
facility: Karlskoga Hospital
city: Stockholm
country: Sweden
facility: Capio S:t Görans Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Visby
country: Sweden
facility: Visby Hospital
city: Västerås
country: Sweden
facility: Västmanland County Hospital Västerås
city: Växjö
country: Sweden
facility: Växsjö Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
city: Östersund
country: Sweden
facility: Östersund hospital
Study officials:
affiliation: Karolinska University Hospital
name: Daniel P Andersson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Capio S:t Görans Hospital and Karolinska University Hospital
name: Ola Blennow, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: