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According to In vitro studies, ciclesonide showed good antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although some cases were reported for the clinical effectiveness of ciclesonide in the treatment of COVID-19, there is no clinical trial to evaluate the antiviral effect on the reduction of viral load in patients with COVID-19. In this study, we aimed to investigate whether ciclesonide inhalation could eradicate SARS-CoV-2 compared to standard supportive care in patients with mild COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciclesonide | Experimental | Ciclesonide 320ug oral inhalation q12h for 14 days |
|
| Control | No Intervention | Standard care without ciclesonide |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide Metered Dose Inhaler [Alvesco] | Drug | Ciclesonide 320ug oral inhalation q12h for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of SARS-CoV-2 eradication at day 14 from study enrollment | Viral load | Hospital day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of SARS-CoV-2 eradication at day 7 from study enrollment | Viral load | Hospital day 7 |
| Time to SARS-CoV-2 eradication (days) | Viral load |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of study drug | Number of adverse events, proportion of early discontinuance | Up to 28 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34441840 | Derived | Song JY, Yoon JG, Seo YB, Lee J, Eom JS, Lee JS, Choi WS, Lee EY, Choi YA, Hyun HJ, Seong H, Noh JY, Cheong HJ, Kim WJ. Ciclesonide Inhaler Treatment for Mild-to-Moderate COVID-19: A Randomized, Open-Label, Phase 2 Trial. J Clin Med. 2021 Aug 12;10(16):3545. doi: 10.3390/jcm10163545. | |
| 33388170 | Derived | Farne H, Singanayagam A. Reply. J Allergy Clin Immunol. 2021 Mar;147(3):1117-1118. doi: 10.1016/j.jaci.2020.11.019. Epub 2020 Dec 30. No abstract available. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C120481 | ciclesonide |
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This multicenter study is an open-labelled, randomized clinical trial for 1:1 ratio of ciclesonide or control arm (standard care)
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| Hospital day 1, 4, 7, 10, 14, 21 |
| Viral load area-under-the-curve (AUC) reduction versus control | Viral load change | Hospital day 1, 4, 7, 10, 14, 21 |
| Time to clinical improvement (days) | Resolution of all systemic and respiratory symptoms for ≥2 consecutive days | Up to 28 days |
| Proportion of clinical failure | High-flow oxygen therapy or mechanical ventilation requiring salvage therapy | Up to 28 days |
| 32738928 | Derived | Nicolau DV, Bafadhel M. Inhaled corticosteroids in virus pandemics: a treatment for COVID-19? Lancet Respir Med. 2020 Sep;8(9):846-847. doi: 10.1016/S2213-2600(20)30314-3. Epub 2020 Jul 30. No abstract available. |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |