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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ciclesonide
Placebo
Sponsored by
Covis Pharma S.à.r.l.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

12 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Buffalo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI

Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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
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.

Full Information

First Posted
May 5, 2020
Last Updated
February 7, 2023
Sponsor
Covis Pharma S.à.r.l.
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1. Study Identification

Unique Protocol Identification Number
NCT04377711
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
January 5, 2021 (Actual)
Study Completion Date
January 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Covis Pharma S.à.r.l.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double Blind
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI
Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Other Intervention Name(s)
Alvesco
Intervention Description
160mcg Inhaler
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo Inhaler
Primary Outcome Measure Information:
Title
Time to Alleviation of COVID-19-related Symptoms by Day 30
Description
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
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Percentage of Patients With Hospital Admission or Death by Day 30
Description
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.
Time Frame
Day 30
Title
All-cause Mortality by Day 30
Description
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.
Time Frame
Day 30
Title
COVID-19-related Mortality by Day 30
Description
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.
Time Frame
Day 30
Title
Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by Day 30
Description
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
Time Frame
Day 30
Title
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
Description
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.
Time Frame
By day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34807241
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.
Results Reference
derived
PubMed Identifier
33388170
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.
Results Reference
derived
PubMed Identifier
32738928
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.
Results Reference
derived

Learn more about this trial

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

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