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History of Changes for Study: NCT04377711
A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients
Latest version (submitted January 6, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 5, 2020 None (earliest Version on record)
2 May 19, 2020 Outcome Measures, Eligibility and Study Status
3 June 9, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 April 9, 2021 Recruitment Status, Study Status, Outcome Measures, Contacts/Locations and Study Design
5 April 13, 2021 Outcome Measures and Study Status
6 August 10, 2021 Study Status and Document Section
7 December 8, 2021
Quality Control Review has not concluded Returned: December 14, 2021
Outcome Measures, Study Status, Arms and Interventions and Study Description
8 December 17, 2021
Quality Control Review has not concluded Returned: December 29, 2021
Outcome Measures, Adverse Events, Participant Flow and Study Status
9 January 4, 2022 Study Status, Outcome Measures
10 January 6, 2022 Study Status
Comparison Format:

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Changes (Side-by-Side) for Study: NCT04377711
June 9, 2020 (v3) -- April 9, 2021 (v4)

Changes in: Study Status, Study Design, Outcome Measures and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: ALV-020-001 ALV-020-001
Brief Title: A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients 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 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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2020 April 2021
Overall Status: RecruitingCompleted
Study Start: June 8, 2020 June 8, 2020
Primary Completion: September 1, 2020 [Anticipated] January 5, 2021 [Actual]
Study Completion: December 1, 2020 [Anticipated] January 5, 2021 [Actual]
First Submitted: May 5, 2020 May 5, 2020
First Submitted that
Met QC Criteria:
May 5, 2020 May 5, 2020
First Posted: May 6, 2020 [Actual] May 6, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
June 9, 2020 April 9, 2021
Last Update Posted: June 11, 2020 [Actual] April 14, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Covis Pharma S.à.r.l. Covis Pharma S.à.r.l.
Responsible Party: Sponsor Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: YesYes
U.S. FDA-regulated Device: NoNo
Data Monitoring:
Open or close this module 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 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:
Open or close this module Conditions
Conditions: COVID-19 COVID-19
Keywords:
Open or close this module Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 3Phase 3
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 22
Masking: Double (Participant, Investigator)Double (Participant, Investigator)
Allocation: RandomizedRandomized
Enrollment: 400 [Anticipated] 400 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of patients hospital admission or death by day 30
[ Time Frame: Day 30 ]

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 ]

Per above
1 2. All-cause mortality by day 30
[ Time Frame: Day 30 ]

All-cause mortality by day 30
[ Time Frame: Day 30 ]

Per above
2 3. COVID-19-related mortality by day 30
[ Time Frame: Day 30 ]

COVID-19-related mortality by day 30
[ Time Frame: Day 30 ]

Per above
3 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 ]

Percentage of patients with subsequent emergency department visit or hospital admission for reasons attributable to COVID-19 by day 30
[ Time Frame: Day 30 ]

Per above
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: Day 30 ]

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, 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
4 6. Time to hospital admission or death
[ Time Frame: Day 30 ]

Time to hospital admission or death
[ Time Frame: Day 30 ]

Per above
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 7. Change from baseline in oxygen saturation levels
[ Time Frame: Day 30 ]

Change from baseline in oxygen saturation levels
[ Time Frame: Day 30 ]

Per above
7 8. Change from baseline in COVID-19 viral load in nasopharyngel sample nasal secretions at day 30
[ Time Frame: Day 30 ]

Change from baseline in COVID-19 viral load in nasopharyngeal sample at day 30
[ Time Frame: Day 30 ]

Per above
8 . Safety will be assessed based on adverse events.
[ Time Frame: Day 60 ]

Open or close this module Eligibility
Minimum Age: 12 Years 12 Years
Maximum Age: 100 Years 100 Years
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
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.

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.
Open or close this module Contacts/Locations
Locations: United States, New YorkUnited States, New York
University of Buffalo
[Recruiting]
Buffalo, New York, United States, 14203
Contact:Contact: Dr Clemency, MD 716-604-7554 bc34@buffalo.edu
University of Buffalo
Buffalo, New York, United States, 14203
Open or close this module IPDSharing
Plan to Share IPD: No No
Open or close this module References
Links:
Available IPD/Information:

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