COVID-19Phase 2NCT04330586
A Trial of Ciclesonide in Adults With Mild-to-moderate COVID-19
A Phase 2 study testing Ciclesonide Metered Dose Inhaler [Alvesco] in people with COVID-19, run by Korea University Guro Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Ciclesonide Metered Dose Inhaler [Alvesco]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2020to 31 Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial of Ciclesonide to Assess The Antiviral Effect for Adults With Mild-to-moderate COVID-19
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.
- Conditions
- COVID-19
- Being tested
- Ciclesonide Metered Dose Inhaler [Alvesco]
- Keywords
- SARS-CoV-2, Ciclesonide, Viral load, Coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclesonide Metered Dose Inhaler [Alvesco]Drug
Ciclesonide 320ug oral inhalation q12h for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Ciclesonide | Experimental | Ciclesonide 320ug oral inhalation q12h for 14 days Receives: Drug: Ciclesonide Metered Dose Inhaler [Alvesco] |
| Control | No intervention | Standard care without ciclesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of SARS-CoV-2 eradication at day 14 from study enrollment
Viral load
Measured: Hospital day 14
Secondary outcomes (5)
Rate of SARS-CoV-2 eradication at day 7 from study enrollment
Viral load
Measured: Hospital day 7
Time to SARS-CoV-2 eradication (days)
Viral load
Measured: Hospital day 1, 4, 7, 10, 14, 21
Viral load area-under-the-curve (AUC) reduction versus control
Viral load change
Measured: Hospital day 1, 4, 7, 10, 14, 21
Time to clinical improvement (days)
Resolution of all systemic and respiratory symptoms for ≥2 consecutive days
Measured: Up to 28 days
Proportion of clinical failure
High-flow oxygen therapy or mechanical ventilation requiring salvage therapy
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Apr 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This multicenter study is an open-labelled, randomized clinical trial for 1:1 ratio of ciclesonide or control arm (standard care)
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Joo Kim, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330586
- Sponsor's protocol ID
- KUMC-COVID-19
- Status last verified
- Jun 2021
- First submitted
- 31 Mar 2020
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34441840Farne 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.
PubMed 33388170Nicolau 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.
PubMed 32738928
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Ciclesonide to Assess The Antiviral Effect for Adults With Mild-to-moderate COVID-19
- ClinicalTrials.gov ID
- NCT04330586
- Acronym / sponsor ID
- KUMC-COVID-19
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Ciclesonide, Viral load, Coronavirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This multicenter study is an open-labelled, randomized clinical trial for 1:1 ratio of ciclesonide or control arm (standard care)
| Arm | Type | Receives |
|---|---|---|
| Ciclesonide | Experimental | Drug: Ciclesonide Metered Dose Inhaler [Alvesco]Ciclesonide 320ug oral inhalation q12h for 14 days |
| Control | No intervention | –Standard care without ciclesonide |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- Hypoxia (SaO2 <95%)
- Unable to take oral medication
- Unable to use inhaler
- Pregnancy or breast feeding
- Immunocompromising conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciclesonide Metered Dose Inhaler [Alvesco]Ciclesonide 320ug oral inhalation q12h for 14 days | Drug | Ciclesonide |
Primary outcome
Rate of SARS-CoV-2 eradication at day 14 from study enrollment
Time frame: Hospital day 14
Viral load
5 secondary outcomes
Rate of SARS-CoV-2 eradication at day 7 from study enrollment
Time frame: Hospital day 7
Time to SARS-CoV-2 eradication (days)
Time frame: Hospital day 1, 4, 7, 10, 14, 21
Viral load area-under-the-curve (AUC) reduction versus control
Time frame: Hospital day 1, 4, 7, 10, 14, 21
Time to clinical improvement (days)
Time frame: Up to 28 days
Proportion of clinical failure
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Derived from this study: PubMed 34441840Song 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.
- Derived from this study: PubMed 33388170Farne 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.
- Derived from this study: PubMed 32738928Nicolau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ciclesonide Metered Dose Inhaler [Alvesco] in people with COVID-19, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of SARS-CoV-2 eradication at day 14 from study enrollment (time frame: Hospital day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04330586, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.