Status:
COMPLETED
A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients
Lead Sponsor:
Covis Pharma S.à.r.l.
Conditions:
COVID-19
Eligibility:
All Genders
12-100 years
Phase:
PHASE3
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...
Detailed Description
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 patient...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2021
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04377711
Start Date
June 8 2020
End Date
January 5 2021
Last Update
February 9 2023
Active Locations (1)
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1
University of Buffalo
Buffalo, New York, United States, 14203