Status:
UNKNOWN
Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)
Lead Sponsor:
Ola Blennow, MD, PhD
Collaborating Sponsors:
Karolinska University Hospital
Danderyd Hospital
Conditions:
Covid-19
Pneumonia, Viral
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 CO...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT04381364
Start Date
May 29 2020
End Date
January 31 2022
Last Update
February 2 2022
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Södra Älvsborg hospital
Borås, Sweden
2
Danderyd Hospital
Danderyd, Sweden
3
Halmstad hospital
Halmstad, Sweden
4
Karlskoga Hospital
Karlskoga, Sweden