Trial NCT04330586
Publication Song JY, J Clin Med, 2021 (published paper)
Dates: 2020-05-08 to 2021-03-31
Funding: Mixed (National Research Foundation of Korea; Korea University Guro Hospital grant that was underwritten by the SK Chemicals Corporation)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / South Korea Follow-up duration (days): 28 | |
| Inclusion criteria | Aged ≥19 years; mild-to-moderate COVID-19, confirmed by quantitative reverse transcription polymerase chain reaction (qRT-PCR); 3 days of diagnosis or within 7 days from symptom onset; low National Early Warning Score (NEWS) ranging from 0 to 4 |
| Exclusion criteria | oxygen saturation <95% breathing room air; pregnancy or breastfeeding; renal impairment (estimated creatinine clearance <30 mL/min); hepatic dysfunction (alanine aminotransferase or aspartate aminotransferase levels more than five times the upper limit of normal); immunocompromising conditions; severe uncontrolled comorbidities; chronic airway diseases (asthma and chronic obstructive lung disease); and contraindications for use of ciclesonide inhaler. |
| Interventions | |
| Treatment
Ciclesonide 320 mcg inhaled twice daily for 14 days |
|
| Control
Standard care ( / ) Definition of Standard care: Standard care comprised intravenous fluid, supplementary oxygen, and antibiotics, as necessary. Clinical failure was defined as the case of clinical deterioration requiring high-flow nasal oxygen or mechanical ventilation, resulting in salvage treatment with dexamethasone and remdesivir. | |
| Participants | |
| Randomized * participants (n1=* / n2= *) | |
| Characteristics of participants N=* Mean age : NR 20 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Rate of SARS-CoV-2 eradication at day 14 from study enrollment [ Time Frame: Hospital day 14 ] Viral load | |
| In the report SARS-CoV-2 eradication rate based on qRT-PCR on day 14 of study enrollment | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
|
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
High |
| General comment | In addition to the published article, the prospective registry was used in data extraction and assessment of risk of bias. Neither protocol not statistical analysis plan was available. The primary outcome reported reflects that in the registry. There were no substantive differences between the registry and the article in outcomes. During the trial period, evidence of the ineffectiveness of hydroxychloroquine was published and a third ciclesonide plus hydroxychloroquine arm was combined with the ciclesonide alone arm. Eight patients in the ciclesonide group received oral HCQ treatment concomitantly for 10 days. 68 participants were randomized and only 61 were analyzed. Reasons for exclusion from analysis are reported but arms are not indicated. |