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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 : Not yet recruiting
First Posted : May 6, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Covis Pharma S.à.r.l.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 26, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ciclesonide

Arm Intervention/treatment
Active Comparator: Group 1
Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI
Drug: Ciclesonide
160mcg Inhaler

Placebo Comparator: Group 2
Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI
Drug: Placebo
Matching Placebo Inhaler




Primary Outcome Measures :
  1. Percentage of patients hospital admission or death by day 30 [ Time Frame: Day 30 ]

Secondary Outcome Measures :
  1. All-cause mortality by day 30 [ Time Frame: Day 30 ]
  2. COVID-19-related mortality by day 30 [ Time Frame: Day 30 ]
  3. Percentage of patients with subsequent emergency department visit or hospital admission for reasons attributable to COVID 19 by day 30 [ Time Frame: Day 30 ]
  4. Time to hospital admission or death [ Time Frame: Day 30 ]
  5. 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 ]
  6. Change from baseline in oxygen saturation levels [ Time Frame: Day 30 ]
  7. Change from baseline in COVID-19 viral load in nasopharyngel sample nasal secretions at day 30 [ Time Frame: Day 30 ]
  8. Safety will be assessed based on adverse events. [ Time Frame: Day 60 ]


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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.
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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
Last Update Posted: May 21, 2020
Last Verified: May 2020
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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Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents