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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377711
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Covis Pharma S.à.r.l.

Tracking Information
First Submitted Date  ICMJE May 5, 2020
First Posted Date  ICMJE May 6, 2020
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE June 8, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2020)
Percentage of patients hospital admission or death by day 30 [ Time Frame: Day 30 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2020)
Percentage of patients with subsequent emergency department visit or hospital admission for reasons attributable to COVID 19 by day 30 [ Time Frame: Day 30 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2020)
  • All-cause mortality by day 30 [ Time Frame: Day 30 ]
  • COVID-19-related mortality by day 30 [ Time Frame: Day 30 ]
  • Percentage of patients with subsequent emergency department visit or hospital admission for reasons attributable to COVID 19 by day 30 [ Time Frame: Day 30 ]
  • Time to hospital admission or death [ Time Frame: Day 30 ]
  • Time to alleviation of COVID-19-related symptoms of cough, dyspnea, chills, and feeling feverish, defined as symptom-free for a continuous period of more than 24 hours (ie, > 3 AM/PM assessments) [ Time Frame: Day 30 ]
  • Change from baseline in oxygen saturation levels [ Time Frame: Day 30 ]
  • Change from baseline in COVID-19 viral load in nasopharyngel sample nasal secretions at day 30 [ Time Frame: Day 30 ]
  • Safety will be assessed based on adverse events. [ Time Frame: Day 60 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2020)
  • Percentage of patients with subsequent emergency department visit or hospital admission for reasons attributable to COVID 19 by day 15 [ Time Frame: Day 15 ]
  • Time to subsequent emergency department visit or hospital admission for reasons attributable to COVID 19 [ Time Frame: Day 30 ]
  • Time to alleviation of COVID-19-related symptoms of cough, dyspnea, chills, and feeling feverish, defined as symptom-free for a continuous period of more than 24 hours (ie, > 3 AM/PM assessments) [ Time Frame: Day 30 ]
  • Number of alive, hospital admission-free days [ Time Frame: Day 30 ]
  • Change from baseline in oxygen saturation levels [ Time Frame: Day 30 ]
  • Change from baseline in COVID-19 viral load in nasopharyngel sample nasal secretions at day 30 [ Time Frame: Day 30 ]
  • Safety will be assessed based on adverse events. [ Time Frame: Day 60 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double Blind
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Ciclesonide
    160mcg Inhaler
  • Drug: Placebo
    Matching Placebo Inhaler
Study Arms  ICMJE
  • Active Comparator: Group 1
    Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI
    Intervention: Drug: Ciclesonide
  • Placebo Comparator: Group 2
    Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2020)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04377711
Other Study ID Numbers  ICMJE ALV-020-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Covis Pharma S.à.r.l.
Study Sponsor  ICMJE Covis Pharma S.à.r.l.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Covis Pharma S.à.r.l.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP