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Completed

NCT Number: NCT04377711

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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Buffalo

Buffalo, New York, 14203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ciclesonide

Drug

160mcg Inhaler

Other names: Alvesco

Placebo

Drug

Matching Placebo Inhaler

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Covis Pharma S.à.r.l.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 6, 2020
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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