Clinical trial NCT04377711: A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Ciclesonide Metered-Dose Inhaler in Non-hospitalized Patients 12 Years of Age and Older With Symptomatic COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: Covis Pharma S.à.r.l.
Sponsor class: INDUSTRY
First posted: 2020-05-06
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy, and safety study of ciclesonide MDI for the treatment of symptomatic COVID-19 infection. Enrolled patients were male and female adults and adolescents 12 years of age or older with confirmed COVID-19 infection who were currently exhibiting symptoms of the disease and who were not currently hospitalized or under immediate consideration for hospitalization at the time of enrollment. The study consisted of an initial screening/enrollment/randomization visit, a 30-day treatment period, and a follow-up period.

Eligibility criteria: Inclusion Criteria

Patients eligible for enrollment in the study must meet all the following criteria:

1. Male and female adults and adolescents (12 years of age and above).
2. Positive SARS-CoV-2 rapid molecular diagnostic test within 72 hours prior to enrollment.
3. Patient is not currently hospitalized or under immediate consideration for hospitalization at the time of enrollment.
4. Patient is currently experiencing symptoms of fever, cough, and/or dyspnea.
5. Patient has an oxygen saturation level greater than 93%.
6. Ability to show adequate use of MDI, including inhalation technique.
7. 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:

1. 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.
2. History of hypersensitivity to ciclesonide.
3. Treatment with inhaled or intranasal corticosteroids within 14 days of the screening/ enrollment/randomization visit.
4. Treatment with oral corticosteroids within 90 days of the screening/enrollment/randomization visit.
5. Participation in any other clinical trial or use of any investigational agent within 30 days of the screening/enrollment/randomization visit.
6. Currently receiving treatment with hydroxychloroquine/chloroquine.
7. Patients with cystic fibrosis.
8. Patients with idiopathic pulmonary fibrosis.

Primary outcomes:
measure: Time to Alleviation of COVID-19-related Symptoms by Day 30
timeFrame: Day 30
Secondary outcomes:
measure: Percentage of Patients With Hospital Admission or Death by Day 30
timeFrame: Day 30
measure: All-cause Mortality by Day 30
timeFrame: Day 30
measure: COVID-19-related Mortality by Day 30
timeFrame: Day 30
measure: Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by Day 30
timeFrame: Day 30
measure: 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
timeFrame: By day 30
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
Study officials:
References:
citation: Clemency BM, Varughese R, Gonzalez-Rojas Y, Morse CG, Phipatanakul W, Koster DJ, Blaiss MS. Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19: A Randomized Clinical Trial. JAMA Intern Med. 2022 Jan 1;182(1):42-49. doi: 10.1001/jamainternmed.2021.6759.
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.