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

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ola Blennow, MD, PhD
• Collaborators: Centrallasarettet Västerås; Danderyd Hospital; Karolinska University Hospital
• Treatments: Ciclesonide

Criteria

Inclusion Criteria:

1. Patients 18 or older who are willing and able to provide written informed consent.

2. Laboratory-confirmed (PCR-positive) SARS-CoV-2 infection.

3. Receiving supplemental oxygen therapy with start <48 hours before inclusion.

4. Negative pregnancy test (women in fertile age).

5. Agreeing to take highly effective contraceptive measures according to Clinical Trial Facilitation Group criteria during the duration of treatment plus 7 days (women in fertile age).

Exclusion Criteria:

1. Pregnant or breastfeeding women.

2. History of hypersensitivity to ciclesonide or other substances included in the treatment.

3. Ongoing use of corticosteroids, ketokonazol, itrakonazol, ritonavir or nelfinavir.

4. Receiving >8 l oxygen/min or >50 % oxygen with nasal high flow therapy.

5. Ongoing or planned palliative care or an expected survival of less than 72 h.

6. Expected admission to intensive care unit within 48 h.

7. Active or inactive pulmonary tuberculosis.

8. Severe liver failure (Child-Pugh C)

9. Pulmonary arterial hypertension (PAH) or fibrosis.

10. Cognitive or physical impairment or insufficient language skills which precludes understanding of information given about the study.

11. Participation in a clinical trial within the past 30 days.