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

Covis Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: Ciclesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04377711

ALV-020-001

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 400 patients

Sex: All

Ages: 12 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI

Treatment:

Drug: Ciclesonide

Group 2

Placebo Comparator group

Description:

Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI

Treatment:

Drug: Placebo