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CompletedNCT04377711Updated Feb 9, 2023Results posted

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

A Phase 3 interventional study of Ciclesonide and Placebo in COVID-19, sponsored by Covis Pharma S.à.r.l.. Completed at 1 site in United States. Open to participants aged 12 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-02-09.

Sponsored by Covis Pharma S.à.r.l. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
12 Years to 100 Years
Sex
All
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Study 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

Read the 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 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.

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Conditions studied

  • COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 400 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Covis Pharma S.à.r.l. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
400 participants (actual)

Study arms

  • Active comparator
    Group 1

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

    Drug: Ciclesonide

  • Placebo comparator
    Group 2

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

    Drug: Placebo

Interventions

  • DrugCiclesonide

    160mcg Inhaler

    Also known as: Alvesco

  • DrugPlacebo

    Matching Placebo Inhaler

06

What researchers measure

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

    Time frame: Day 30

Secondary outcomes

  1. Percentage of Patients With Hospital Admission or Death by 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.

    Time frame: Day 30

  2. All-cause Mortality by 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.

    Time frame: Day 30

  3. COVID-19-related Mortality by 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.

    Time frame: Day 30

  4. Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by 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

    Time frame: Day 30

  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

    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.

    Time frame: By day 30

07

Results

Posted Jan 6, 2022

Participant flow

Participant flow — Overall Study
MilestoneCiclesonide ArmPlacebo Arm
Started197203
Completed178181
Not completed1922

Outcome measures

PrimaryTime 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

Time frame:
Day 30
Reported as:
Median · days
Time to Alleviation of COVID-19-related Symptoms by Day 30
daysCiclesonide ArmPlacebo Arm
Time to Alleviation of COVID-19-related Symptoms by Day 3019.0 (14.0 to 21.0)19.0 (16.0 to 23.0)
SecondaryPercentage of Patients With Hospital Admission or Death by 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.

Time frame:
Day 30
Reported as:
Number · percentage of patients
Percentage of Patients With Hospital Admission or Death by Day 30
percentage of patientsCiclesonide ArmPlacebo Arm
Percentage of Patients With Hospital Admission or Death by Day 301.53.4
SecondaryAll-cause Mortality by 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.

Time frame:
Day 30
Reported as:
Count of participants · Participants
All-cause Mortality by Day 30
ParticipantsCiclesonide ArmPlacebo Arm
All-cause Mortality by Day 3000
SecondaryCOVID-19-related Mortality by 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.

Time frame:
Day 30
Reported as:
Count of participants · Participants
COVID-19-related Mortality by Day 30
ParticipantsCiclesonide ArmPlacebo Arm
COVID-19-related Mortality by Day 3000
SecondaryPercentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by 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

Time frame:
Day 30
Reported as:
Number · percentage of patients
Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by Day 30
percentage of patientsCiclesonide ArmPlacebo Arm
Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by Day 301.05.4
SecondaryPercentage 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

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.

Time frame:
By day 30
Reported as:
Count of participants · Participants
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
ParticipantsCiclesonide ArmPlacebo Arm
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 30139129

Adverse events

Collected over Adverse events were collected during the 30-day treatment period and 60-day follow up period.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 10/197 (0%)3/197 (1.5%)22/197 (11.2%)
Group 20/203 (0%)7/203 (3.4%)29/203 (14.3%)
Most frequent serious events
Most frequent serious events
EventGroup 1Group 2
COVID-19 (i.e., worsening of COVID-19)Infections and infestations0/1972/203
COVID-19, renal failureRenal and urinary disorders1/1970/203
COVID-19 pneumoniaRespiratory, thoracic and mediastinal disorders1/1971/203
Animal BiteInjury, poisoning and procedural complications1/1970/203
Oxygen saturation decreasedRespiratory, thoracic and mediastinal disorders0/1971/203
HypoxiaVascular disorders0/1971/203
Atrial fibrillation, COVID-19 pneumoniaCardiac disorders0/1971/203
Intestinal obstructionGastrointestinal disorders0/1971/203
Most frequent other events
Showing 10 of 40
Most frequent other events
EventGroup 1Group 2
DyspneaRespiratory, thoracic and mediastinal disorders1/1974/203
HeadacheGeneral disorders1/1974/203
Dry MouthGastrointestinal disorders3/1971/203
COVID-19 (ie, worsening of COVID-19Infections and infestations1/1973/203
DysphoniaRespiratory, thoracic and mediastinal disorders2/1970/203
HypoxiaRespiratory, thoracic and mediastinal disorders0/1972/203
COVID-19 pneumoniaInfections and infestations1/1972/203
DyspepsiaGastrointestinal disorders0/1972/203
Nasal congestionRespiratory, thoracic and mediastinal disorders1/1970/203
Productive CoughRespiratory, thoracic and mediastinal disorders1/1970/203

Baseline characteristics

Age, Continuous
Age, Continuous(years)Group 1Group 2Total
Mean43.7 ± 17.5342.9 ± 16.2843.3 ± 16.89
Sex: Female, Male
Sex: Female, Male(Participants)Group 1Group 2Total
Female112109221
Male8594179
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group 1Group 2Total
Hispanic or Latino8686172
Not Hispanic or Latino111117228
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 1Group 2Total
American Indian or Alaska Native000
Asian112
Native Hawaiian or Other Pacific Islander123
Black or African American202747
White174171345
More than one race011
Unknown or Not Reported112
08

Study locations

1 site
  • University of Buffalo
    Buffalo, New York 14203, United States
09

References and documents

Publications

  • 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. PubMed 34807241 ↗
  • 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. PubMed 33388170 ↗
  • 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. PubMed 32738928 ↗

Study documents

  • Protocol and statistical analysis plan · Dec 21, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04377711
Lead sponsor
Covis Pharma S.à.r.l.
Responsible party
Sponsor
First posted
May 6, 2020
Start date
Jun 8, 2020
Primary completion
Jan 5, 2021
Completion
Jan 5, 2021
Results posted
Jan 6, 2022
Last update
Feb 9, 2023

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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