A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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

Key facts

Study ID

NCT04377711

Run by

Covis Pharma S.à.r.l.

People needed

400

Starts

2020-06-08

Expected to finish

2021-01-05

Last updated by the study team

2023-02-09

Who can join

Age: 12 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Buffalo — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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