A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients
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ClinicalTrials.gov Identifier: NCT04377711 |
Recruitment Status :
Completed
First Posted : May 6, 2020
Results First Posted : January 6, 2022
Last Update Posted : January 11, 2022
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: Ciclesonide Drug: Placebo | Phase 3 |
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 |

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

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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 |
Inclusion Criteria
Patients eligible for enrollment in the study must meet all the following criteria:
- Male and female adults and adolescents (12 years of age and above).
- Positive SARS-CoV-2 rapid molecular diagnostic test within 72 hours prior to enrollment.
- Patient is not currently hospitalized or under immediate consideration for hospitalization at the time of enrollment.
- Patient is currently experiencing symptoms of fever, cough, and/or dyspnea.
- Patient has an oxygen saturation level greater than 93%.
- Ability to show adequate use of MDI, including inhalation technique.
- 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:
- 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.
- History of hypersensitivity to ciclesonide.
- Treatment with inhaled or intranasal corticosteroids within 14 days of the screening/ enrollment/randomization visit.
- Treatment with oral corticosteroids within 90 days of the screening/enrollment/randomization visit.
- Participation in any other clinical trial or use of any investigational agent within 30 days of the screening/enrollment/randomization visit.
- Currently receiving treatment with hydroxychloroquine/chloroquine.
- Patients with cystic fibrosis.
- Patients with idiopathic pulmonary fibrosis.

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
United States, New York | |
University of Buffalo | |
Buffalo, New York, United States, 14203 |
Documents provided by Covis Pharma S.à.r.l.:
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |