Trial Outcomes & Findings for A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients (NCT NCT04377711)

Last Updated: 2023-02-09

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

400 participants

Primary outcome timeframe

Day 30

Results posted on

2023-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Ciclesonide Arm Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI Ciclesonide: 160mcg Inhaler	Placebo Arm Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI Placebo: Matching Placebo Inhaler
Overall Study STARTED	197	203
Overall Study COMPLETED	178	181
Overall Study NOT COMPLETED	19	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=197 Participants Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI Ciclesonide: 160mcg Inhaler	Group 2 n=203 Participants Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI Placebo: Matching Placebo Inhaler	Total n=400 Participants Total of all reporting groups
Age, Continuous	43.7 years STANDARD_DEVIATION 17.53 • n=93 Participants	42.9 years STANDARD_DEVIATION 16.28 • n=4 Participants	43.3 years STANDARD_DEVIATION 16.89 • n=27 Participants
Sex: Female, Male Female	112 Participants n=93 Participants	109 Participants n=4 Participants	221 Participants n=27 Participants
Sex: Female, Male Male	85 Participants n=93 Participants	94 Participants n=4 Participants	179 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	86 Participants n=93 Participants	86 Participants n=4 Participants	172 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	111 Participants n=93 Participants	117 Participants n=4 Participants	228 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Black or African American	20 Participants n=93 Participants	27 Participants n=4 Participants	47 Participants n=27 Participants
Race (NIH/OMB) White	174 Participants n=93 Participants	171 Participants n=4 Participants	345 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: Day 30

Outcome measures

Outcome measures
Measure	Ciclesonide Arm n=197 Participants Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI Ciclesonide: 160mcg Inhaler	Placebo Arm n=203 Participants Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI Placebo: Matching Placebo Inhaler
Time to Alleviation of COVID-19-related Symptoms by Day 30	19.0 days Interval 14.0 to 21.0	19.0 days Interval 16.0 to 23.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ciclesonide Arm n=197 Participants Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI Ciclesonide: 160mcg Inhaler	Placebo Arm n=203 Participants Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI Placebo: Matching Placebo Inhaler
Percentage of Patients With Hospital Admission or Death by Day 30	1.5 percentage of patients	3.4 percentage of patients

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ciclesonide Arm n=197 Participants Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI Ciclesonide: 160mcg Inhaler	Placebo Arm n=203 Participants Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI Placebo: Matching Placebo Inhaler
All-cause Mortality by Day 30	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ciclesonide Arm n=197 Participants Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI Ciclesonide: 160mcg Inhaler	Placebo Arm n=203 Participants Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI Placebo: Matching Placebo Inhaler
COVID-19-related Mortality by Day 30	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Ciclesonide Arm n=197 Participants Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI Ciclesonide: 160mcg Inhaler	Placebo Arm n=203 Participants Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI Placebo: Matching Placebo Inhaler
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	5.4 percentage of patients

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ciclesonide Arm n=197 Participants Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI Ciclesonide: 160mcg Inhaler	Placebo Arm n=203 Participants Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI Placebo: Matching Placebo Inhaler
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	129 Participants

Adverse Events

Group 1

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

Group 2

Serious events: 7 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=197 participants at risk Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI Ciclesonide: 160mcg Inhaler	Group 2 n=203 participants at risk Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI Placebo: Matching Placebo Inhaler
Renal and urinary disorders COVID-19, renal failure	0.51% 1/197 • Number of events 1 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Respiratory, thoracic and mediastinal disorders COVID-19 pneumonia	0.51% 1/197 • Number of events 1 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Number of events 1 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Injury, poisoning and procedural complications Animal Bite	0.51% 1/197 • Number of events 1 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Respiratory, thoracic and mediastinal disorders Oxygen saturation decreased	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Number of events 1 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Vascular disorders Hypoxia	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Number of events 1 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Cardiac disorders Atrial fibrillation, COVID-19 pneumonia	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Number of events 1 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Infections and infestations COVID-19 (i.e., worsening of COVID-19)	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.99% 2/203 • Number of events 2 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Number of events 1 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.

Other adverse events

Additional Information

Clinical Trial Interest

Covis Pharma

Phone: 1-877-374 -4177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group 1 n=197 participants at risk Participants receive Alvesco 320mcg, twice daily for 30 days via pMDI Ciclesonide: 160mcg Inhaler	Group 2 n=203 participants at risk Participants receive Placebo matching Alvesco , twice daily for 30 days via pMDI Placebo: Matching Placebo Inhaler
Respiratory, thoracic and mediastinal disorders Dyspnea	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	2.0% 4/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
General disorders Headache	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	2.0% 4/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Gastrointestinal disorders Dry Mouth	1.5% 3/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Infections and infestations COVID-19 (ie, worsening of COVID-19	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	1.5% 3/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Respiratory, thoracic and mediastinal disorders Dysphonia	1.0% 2/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.99% 2/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Infections and infestations COVID-19 pneumonia	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.99% 2/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Infections and infestations Oral Candidiasis	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Infections and infestations Cellulitis	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Infections and infestations Conjunctivitis	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Infections and infestations Urinary tract infection	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Infections and infestations Varicella zoster virus infection	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Gastrointestinal disorders Dyspepsia	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.99% 2/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Gastrointestinal disorders Diarrhoea	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Gastrointestinal disorders Nausea	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Nervous system disorders Dizziness	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Nervous system disorders Hypoaesthesia	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Nervous system disorders Paraesthesia	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Nervous system disorders Piriformis syndrome	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
General disorders Chest discomfort	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
General disorders Fatigue	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Cardiac disorders Atrial fibrillation	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Cardiac disorders Bradycardia	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Injury, poisoning and procedural complications Animal bite	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Injury, poisoning and procedural complications Tendon injury	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Musculoskeletal and connective tissue disorders Back pain	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Musculoskeletal and connective tissue disorders Neck pain	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Psychiatric disorders Insomnia	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Psychiatric disorders Panic attack	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Renal and urinary disorders Nephrolithiasis	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Renal and urinary disorders Renal failure	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.51% 1/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.00% 0/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.
Skin and subcutaneous tissue disorders Rash	0.00% 0/197 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.	0.49% 1/203 • Adverse events were collected during the 30-day treatment period and 60-day follow up period.