Phase 3
Completed N=400
A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients
Source: ClinicalTrials.gov NCT04377711 ↗Enrolled (actual)
400
Serious AEs
2.5%
Results posted
Jan 2022
Primary outcomePrimary: Time to Alleviation of COVID-19-related Symptoms by Day 30 — 19.0; 19.0 days
◆ Published Evidence
Highly cited
106citations · ~27 / year
Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19: A Randomized Clinical Trial.
Summary
The purpose of this study is to assess the safety and efficacy of Alvesco (ciclesonide) Inhalation Aerosol in non hospitalized patients with symptomatic COVID-19 infection in a multicenter, randomized, double-blind, placebo controlled study
Linked Publications (3)
-
Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19: A Randomized Clinical Trial.
-
Inhaled corticosteroids in virus pandemics: a treatment for COVID-19?
-
Reply.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Alleviation of COVID-19-related Symptoms by Day 30 |
19.0; 19.0 | — |
| SECONDARY Percentage of Patients With Hospital Admission or Death by Day 30 |
1.5; 3.4 | — |
| SECONDARY All-cause Mortality by Day 30 |
0; 0 | — |
| SECONDARY COVID-19-related Mortality by Day 30 |
0; 0 | — |
| SECONDARY Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by Day 30 |
1.0; 5.4 | — |
| SECONDARY Percentage of Patients With Alleviation of COVID-19-related Symptoms Defined as Symptom-free for a Continuous Period of More Than 24 Hours (ie, Later Than 3 AM/PM Assessments) by Day 7, by Day 14, and by Day 30 |
139; 129 | — |
Eligibility Criteria
Inclusion Criteria
Patients eligible for enrollment in the study must meet all the following criteria:
- Male and female adults and adolescents (12 years of age and above).
- Positive SARS-CoV-2 rapid molecular diagnostic test within 72 hours prior to enrollment.
- Patient is not currently hospitalized or under immediate consideration for hospitalization at the time of enrollment.
- Patient is currently experiencing symptoms of fever, cough, and/or dyspnea.
- Patient has an oxygen saturation level greater than 93%.
- Ability to show adequate use of MDI, including inhalation technique.
- Patient, parent/legal guardian, or legally-authorized representative must have signed a written informed consent before administration of any study-specific procedures.
Exclusion Criteria
Patients meeting any of the following criteria are not eligible for participation in the study:
- Existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.
- History of hypersensitivity to ciclesonide.
- Treatment with inhaled or intranasal corticosteroids within 14 days of the screening/ enrollment/randomization visit.
- Treatment with oral corticosteroids within 90 days of the screening/enrollment/randomization visit.
- Participation in any other clinical trial or use of any investigational agent within 30 days of the screening/enrollment/randomization visit.
- Currently receiving treatment with hydroxychloroquine/chloroquine.
- Patients with cystic fibrosis.
- Patients with idiopathic pulmonary fibrosis.
Data sourced from ClinicalTrials.gov (NCT04377711) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.