Clinical trial NCT04330586: A Trial of Ciclesonide in Adults With Mild-to-moderate COVID-19
Official title: A Trial of Ciclesonide to Assess The Antiviral Effect for Adults With Mild-to-moderate COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: SARS-CoV-2
Ciclesonide
Viral load
Coronavirus
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 68
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
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 (standard care)
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients with mild COVID-19 (NEWS scoring system 0-4)
* Patient within 7 days from symptom onset or Patient within 48 hous after laboratory diagnosis (SARS-CoV-2 RT-PCR)

Exclusion Criteria:

* Hypoxia (SaO2 \<95%)
* Unable to take oral medication
* Unable to use inhaler
* Pregnancy or breast feeding
* Immunocompromising conditions
* Moderate/severe renal dysfunction : creatinine clearance (CCL) \< 30 mL/min
* Moderate/severe liver dysfunction: AST or ALT \> 5 times upper normal limit
* Asthma or chronic obstructive lung disease

Primary outcomes:
measure: Rate of SARS-CoV-2 eradication at day 14 from study enrollment
timeFrame: Hospital day 14
Secondary outcomes:
measure: Rate of SARS-CoV-2 eradication at day 7 from study enrollment
timeFrame: Hospital day 7
measure: Time to SARS-CoV-2 eradication (days)
timeFrame: Hospital day 1, 4, 7, 10, 14, 21
measure: Viral load area-under-the-curve (AUC) reduction versus control
timeFrame: Hospital day 1, 4, 7, 10, 14, 21
measure: Time to clinical improvement (days)
timeFrame: Up to 28 days
measure: Proportion of clinical failure
timeFrame: Up to 28 days
Other outcomes:
measure: Safety and tolerability of study drug
timeFrame: Up to 28 days
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.