A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients

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

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Ciclesonide; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • University of Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group 1; Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI	Drug: Ciclesonide; 160mcg Inhaler; Other Names: Alvesco
PLACEBO_COMPARATOR: Group 2; Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI	Drug: Placebo; Matching Placebo Inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Alleviation of COVID-19-related Symptoms by Day 30	Time to alleviation of COVID-19-related symptoms of cough, dyspnea, chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell, defined as symptom-free for a continuous period of more than 24 hours (ie, later than 3 AM/PM assessments) by day 30	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Hospital Admission or Death by Day 30	Assess whether treatment with ciclesonide MDI (Metered Dose Inhaler) plus standard supportive care reduces the incidence of hospital admissions or death compared with placebo plus standard supportive care in non-hospitalized patients with symptomatic COVID-19 infection.	Day 30
All-cause Mortality by Day 30	Assess whether treatment with ciclesonide MDI plus standard supportive care reduces all-cause mortality compared with placebo plus standard supportive care in non-hospitalized patients with symptomatic COVID-19 infection.	Day 30
COVID-19-related Mortality by Day 30	Assess whether treatment with ciclesonide MDI plus standard supportive care reduces COVID-19-related mortality compared with placebo plus standard supportive care in non-hospitalized patients with symptomatic COVID-19 infection.	Day 30
Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by Day 30	Assess whether treatment with ciclesonide MDI plus standard supportive care reduces the incidence of subsequent emergency department visits or hospital admissions for reasons attributable to COVID-19 compared with placebo plus standard supportive care in non-hospitalized patients with symptomatic COVID-19 infection	Day 30
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	Assess whether treatment with ciclesonide MDI plus standard supportive care increases the percentage of patients with alleviation of COVID 19-related symptoms of cough, dyspnea, chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell compared with placebo plus standard supportive care in non-hospitalized patients with symptomatic COVID-19 infection.	By day 30

Collaborators and Investigators

• Sponsor: Covis Pharma S.à.r.l.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 8, 2020
• Primary Completion (ACTUAL): January 5, 2021
• Study Completion (ACTUAL): January 5, 2021

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (ACTUAL): May 6, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Allergic Agents; Ciclesonide
• Other Study ID Numbers: ALV-020-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No