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

Phase 2

• Conditions: Sars-CoV2; Covid-19; Pneumonia, Viral
• Interventions: Drug: Ciclesonide Inhalation Aerosol

• Registration Number: NCT04381364
• Lead Sponsor: Ola Blennow, MD, PhD

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 available

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-08
• Study Start: 2020-05-29
• Primary Completion: 2021-08-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-18
• Study Completion: 2022-01-31
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical treatment	Ciclesonide Inhalation Aerosol	Treatment with ciclesonide

Primary Outcome Measures

Name	Time	Method
Duration of received supplemental oxygen therapy	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

Name	Time	Method
Remaining dyspnea symptoms	30-35 days and 5-7 months after inclusion	Level of remaining dyspnea symptoms according to the Modified Medical Research Council Dyspnea Scale
Invasive mechanical ventilation or all-cause death (key secondary outcome)	30 days after study inclusion	Rate of and time to (in days) received invasive mechanical ventilation or all-cause death
Need for intensive care	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	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.
Invasive mechanical ventilation	30 days after study inclusion	Rate of and time to (in days) received invasive mechanical ventilation
All cause death	30 days after study inclusion	Rate of and time to (in days) death of any cause

Trial Locations

Locations (11)

Södra Älvsborg hospital; 🇸🇪 Borås, Sweden

Danderyd Hospital; 🇸🇪 Danderyd, Sweden

Halmstad hospital; 🇸🇪 Halmstad, Sweden

Karlskoga Hospital; 🇸🇪 Karlskoga, Sweden

Karolinska University Hospital Huddinge; 🇸🇪 Stockholm, Sweden

Capio S:t Görans Hospital; 🇸🇪 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