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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI |
|
| Group 2 | Placebo Comparator | Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide | Drug | 160mcg Inhaler |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 30 |
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Inclusion Criteria
Patients eligible for enrollment in the study must meet all the following criteria:
Exclusion Criteria
Patients meeting any of the following criteria are not eligible for participation in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Buffalo | Buffalo | New York | 14203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34807241 | Derived | 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. | |
| 33388170 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ciclesonide Arm | Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI Ciclesonide: 160mcg Inhaler |
| FG001 | Placebo Arm | Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI Placebo: Matching Placebo Inhaler |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI Ciclesonide: 160mcg Inhaler |
| BG001 | Group 2 | Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI Placebo: Matching Placebo Inhaler |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | 95% Confidence Interval | days | Day 30 |
|
Adverse events were collected during the 30-day treatment period and 60-day follow up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI Ciclesonide: 160mcg Inhaler |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19, renal failure | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Interest | Covis Pharma | 1-877-374 -4177 | CTInterest@covispharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2020 | Aug 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C120481 | ciclesonide |
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Double Blind
| Placebo |
| Drug |
Matching Placebo Inhaler |
|
| 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. | Day 30 |
| 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. | Day 30 |
| 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 | Day 30 |
| 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. | By day 30 |
| 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. |
| 32738928 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Number | percentage of patients | Day 30 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | No | Day 30 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | No | Day 30 |
|
|
|
| Secondary | 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 | Posted | Number | percentage of patients | Day 30 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | By day 30 |
|
|
|
| 0 |
| 197 |
| 3 |
| 197 |
| 22 |
| 197 |
| EG001 | Group 2 | Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI Placebo: Matching Placebo Inhaler | 0 | 203 | 7 | 203 | 29 | 203 |
| COVID-19 pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Animal Bite | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Oxygen saturation decreased | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypoxia | Vascular disorders | Systematic Assessment |
|
| Atrial fibrillation, COVID-19 pneumonia | Cardiac disorders | Systematic Assessment |
|
| COVID-19 (i.e., worsening of COVID-19) | Infections and infestations | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
|
| COVID-19 (ie, worsening of COVID-19 | Infections and infestations | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinus pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Varicella zoster virus infection | Infections and infestations | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Piriformis syndrome | Nervous system disorders | Systematic Assessment |
|
| Chest discomfort | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tendon injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |