COVID-19
Conditions
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
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.
Interventions
DRUGCiclesonide
160mcg Inhaler
DRUGPlacebo
Matching Placebo Inhaler
Sponsors
Covis Pharma S.à.r.l.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Age
12 Years to 100 Years
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Alleviation of COVID-19-related Symptoms by Day 30 | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Hospital Admission or Death by Day 30 | 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. |
| All-cause Mortality by Day 30 | 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. |
| COVID-19-related Mortality by Day 30 | 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. |
| Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by Day 30 | 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 |
| 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI
Ciclesonide: 160mcg Inhaler | 197 |
| Group 2 Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI
Placebo: Matching Placebo Inhaler | 203 |
| Total | 400 |
Baseline characteristics
| Characteristic | Group 2 | Total | Group 1 |
|---|---|---|---|
| Age, Continuous | 42.9 years STANDARD_DEVIATION 16.28 | 43.3 years STANDARD_DEVIATION 16.89 | 43.7 years STANDARD_DEVIATION 17.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 86 Participants | 172 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 117 Participants | 228 Participants | 111 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 47 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 171 Participants | 345 Participants | 174 Participants |
| Sex: Female, Male Female | 109 Participants | 221 Participants | 112 Participants |
| Sex: Female, Male Male | 94 Participants | 179 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 197 | 0 / 203 |
| other Total, other adverse events | 22 / 197 | 29 / 203 |
| serious Total, serious adverse events | 3 / 197 | 7 / 203 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ciclesonide Arm | Time to Alleviation of COVID-19-related Symptoms by Day 30 | 19.0 days |
| Placebo Arm | Time to Alleviation of COVID-19-related Symptoms by Day 30 | 19.0 days |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ciclesonide Arm | All-cause Mortality by Day 30 | 0 Participants |
| Placebo Arm | All-cause Mortality by Day 30 | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ciclesonide Arm | COVID-19-related Mortality by Day 30 | 0 Participants |
| Placebo Arm | COVID-19-related Mortality by Day 30 | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ciclesonide 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 30 | 139 Participants |
| Placebo 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 30 | 129 Participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide Arm | Percentage of Patients With Hospital Admission or Death by Day 30 | 1.5 percentage of patients |
| Placebo Arm | Percentage of Patients With Hospital Admission or Death by Day 30 | 3.4 percentage of patients |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ciclesonide Arm | Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by Day 30 | 1.0 percentage of patients |
| Placebo Arm | Percentage of Patients With Subsequent Emergency Department Visit or Hospital Admission for Reasons Attributable to COVID-19 by Day 30 | 5.4 percentage of patients |