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

NCT04377711 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ALV-020-001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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, double-blind, placebo controlled study

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Percentage of Patients With Hospital Admission or Death by Day 30

  Day 30

• All-cause Mortality by Day 30

  Day 30

• COVID-19-related Mortality by Day 30

  Day 30

• Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by Day 30

  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

  By day 30

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Drug: Ciclesonide

Group 2

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ciclesonide DRUG

160mcg Inhaler

Also known as: Alvesco

Group 1

Placebo DRUG

Matching Placebo Inhaler

Group 2

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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:
• 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.

Sponsors & Collaborators

• Covis Pharma S.à.r.l.: lead

Study Sites (1)

University of Buffalo

Buffalo, New York, 14203, United States

Location

Related Publications (3)

• 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.

  PMID: 34807241 DERIVED

• 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.

  PMID: 33388170 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.

  PMID: 32738928 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Trial Interest
• Organization: Covis Pharma

CTInterest@covispharma.com

1-877-374 -4177

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 6, 2020
• Study Start: June 8, 2020
• Primary Completion: January 5, 2021
• Study Completion: January 5, 2021
• Last Updated: February 9, 2023
• Results First Posted: January 6, 2022

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)