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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377711
Recruitment Status : Completed
First Posted : May 6, 2020
Results First Posted : January 6, 2022
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Covis Pharma S.à.r.l.

Study Description
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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

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Ciclesonide Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Treatment
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
Actual Study Start Date : June 8, 2020
Actual Primary Completion Date : January 5, 2021
Actual Study Completion Date : January 5, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ciclesonide

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1
Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI
 Drug: Ciclesonide
160mcg Inhaler
Other Name: Alvesco
Placebo Comparator: Group 2
Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI
 Drug: Placebo
Matching Placebo Inhaler


Outcome Measures
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Primary Outcome Measures :
  1. Time to Alleviation of COVID-19-related Symptoms by Day 30 [ Time Frame: 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 :
  1. Percentage of Patients With Hospital Admission or Death by Day 30 [ Time Frame: 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.

  2. All-cause Mortality by Day 30 [ Time Frame: 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.

  3. COVID-19-related Mortality by Day 30 [ Time Frame: 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.

  4. Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by Day 30 [ Time Frame: 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

  5. 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 [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377711


Locations
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United States, New York
University of Buffalo
Buffalo, New York, United States, 14203
Sponsors and Collaborators
Covis Pharma S.à.r.l.
  Study Documents (Full-Text)

Documents provided by Covis Pharma S.à.r.l.:
Study Protocol and Statistical Analysis Plan  [PDF] December 21, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Covis Pharma S.à.r.l.
ClinicalTrials.gov Identifier: NCT04377711    
Other Study ID Numbers: ALV-020-001
First Posted: May 6, 2020    Key Record Dates
Results First Posted: January 6, 2022
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Ciclesonide
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents