Trial Outcomes & Findings for Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections (NCT NCT03455491)
NCT ID: NCT03455491
Last Updated: 2019-11-04
Results Overview
The time before the onset of sustained improvement in clinical symptoms according to the Modified Jackson Scale (no more than 1 point for each symptom), measured in hours from the moment of the first dose of the drug. Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
From the time of randomization up to Day 14
Results posted on
2019-11-04
Participant Flow
Patients receiving both in- and outpatient treatment could be enrolled.
A total of 121 patients were screened to participate in the trial; one patient was withdrawn at screening. 120 patients were randomly assigned into 3 groups.
Participant milestones
| Measure |
Group A
XC221 100 mg orally.
1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period
XC221 100 mg: once daily during 3 days.
|
Group B
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
XC221 200 mg: once daily during 3 days.
|
Group C
Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period
Placebo: once daily during 3 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections
Baseline characteristics by cohort
| Measure |
Group A
n=40 Participants
XC221 100 mg orally.
1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period
XC221 100 mg: once daily during 3 days.
|
Group B
n=40 Participants
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
XC221 200 mg: once daily during 3 days.
|
Group C
n=40 Participants
Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period
Placebo: once daily during 3 days.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 7.3 • n=93 Participants
|
31.1 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
32.2 years
STANDARD_DEVIATION 8.1 • n=27 Participants
|
31.1 years
STANDARD_DEVIATION 7.5 • n=483 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
72 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
48 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
119 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
Russia
|
40 participants
n=93 Participants
|
40 participants
n=4 Participants
|
40 participants
n=27 Participants
|
120 participants
n=483 Participants
|
|
Presence of confirmed viral infection by PCR
Viral infection confirmed by PCR
|
29 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
78 Participants
n=483 Participants
|
|
Presence of confirmed viral infection by PCR
No viral infection confirmed by PCR
|
11 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: From the time of randomization up to Day 14Population: Full Analysis Set (FAS) population
The time before the onset of sustained improvement in clinical symptoms according to the Modified Jackson Scale (no more than 1 point for each symptom), measured in hours from the moment of the first dose of the drug. Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Outcome measures
| Measure |
XC221 100 mg
n=40 Participants
XC221 100 mg orally.
1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period
XC221 100 mg: once daily during 3 days.
|
XC221 200 mg
n=40 Participants
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
XC221 200 mg: once daily during 3 days.
|
Placebo
n=40 Participants
Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period
Placebo: once daily during 3 days.
|
|---|---|---|---|
|
Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI
|
57.38 hours
Interval 53.31 to 73.53
|
67.75 hours
Interval 53.69 to 73.87
|
69.64 hours
Interval 63.56 to 88.97
|
SECONDARY outcome
Timeframe: From the time of randomization assessed up to Day 14Population: FAS population
Time to body temperature normalization since treatment initiation, measured in hours (normalization is regarded as setting of body temperature below 37°C without elevation above these values)
Outcome measures
| Measure |
XC221 100 mg
n=40 Participants
XC221 100 mg orally.
1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period
XC221 100 mg: once daily during 3 days.
|
XC221 200 mg
n=40 Participants
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
XC221 200 mg: once daily during 3 days.
|
Placebo
n=40 Participants
Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period
Placebo: once daily during 3 days.
|
|---|---|---|---|
|
Time to Body Temperature Normalization
|
61.08 hours
Standard Deviation 52.85
|
52.26 hours
Standard Deviation 34.08
|
61.40 hours
Standard Deviation 38.06
|
SECONDARY outcome
Timeframe: From the time of randomization up to Day 14Population: FAS population
The percentage of patients with complications of influenza/acute viral URI
Outcome measures
| Measure |
XC221 100 mg
n=40 Participants
XC221 100 mg orally.
1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period
XC221 100 mg: once daily during 3 days.
|
XC221 200 mg
n=40 Participants
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
XC221 200 mg: once daily during 3 days.
|
Placebo
n=40 Participants
Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period
Placebo: once daily during 3 days.
|
|---|---|---|---|
|
Percentage of Patients With Complications
No complications
|
39 Participants
|
40 Participants
|
40 Participants
|
|
Percentage of Patients With Complications
With complications
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization up to 3 days of treatmentPopulation: FAS population
Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
Outcome measures
| Measure |
XC221 100 mg
n=40 Participants
XC221 100 mg orally.
1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period
XC221 100 mg: once daily during 3 days.
|
XC221 200 mg
n=40 Participants
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
XC221 200 mg: once daily during 3 days.
|
Placebo
n=40 Participants
Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period
Placebo: once daily during 3 days.
|
|---|---|---|---|
|
The Area Under the Curve "Modified Jackson Scale Score" During 3-day Therapy
|
14.6 Ln(units_on_a_scale*sec)
Standard Deviation 0.4
|
14.6 Ln(units_on_a_scale*sec)
Standard Deviation 0.4
|
14.7 Ln(units_on_a_scale*sec)
Standard Deviation 0.4
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=40 participants at risk
XC221 100 mg orally.
1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period
XC221 100 mg: once daily during 3 days.
|
Group B
n=40 participants at risk
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
XC221 200 mg: once daily during 3 days.
|
Group C
n=40 participants at risk
Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period
Placebo: once daily during 3 days.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • Number of events 1 • 16 days
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
|
Respiratory, thoracic and mediastinal disorders
Strengthening cough
|
0.00%
0/40 • 16 days
|
5.0%
2/40 • Number of events 2 • 16 days
|
0.00%
0/40 • 16 days
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
|
Gastrointestinal disorders
Loose stools
|
2.5%
1/40 • Number of events 1 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
0.00%
0/40 • 16 days
|
|
Infections and infestations
Bacterial tonsillitis
|
2.5%
1/40 • Number of events 1 • 16 days
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
|
Infections and infestations
Labial herpes
|
2.5%
1/40 • Number of events 1 • 16 days
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
|
Blood and lymphatic system disorders
Basophilia
|
2.5%
1/40 • Number of events 1 • 16 days
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
|
Blood and lymphatic system disorders
Eosinophilia
|
2.5%
1/40 • Number of events 1 • 16 days
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
|
Ear and labyrinth disorders
Nasal congestion
|
2.5%
1/40 • Number of events 1 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
|
Ear and labyrinth disorders
Hoarseness
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
|
Ear and labyrinth disorders
Tickling
|
2.5%
1/40 • Number of events 1 • 16 days
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
|
Ear and labyrinth disorders
Rhinorrhea
|
2.5%
1/40 • Number of events 1 • 16 days
|
5.0%
2/40 • Number of events 2 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
|
Ear and labyrinth disorders
Increased nasal congestion
|
5.0%
2/40 • Number of events 2 • 16 days
|
5.0%
2/40 • Number of events 2 • 16 days
|
7.5%
3/40 • Number of events 3 • 16 days
|
|
Ear and labyrinth disorders
Increased hoarseness
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
|
Ear and labyrinth disorders
Tickering
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
5.0%
2/40 • Number of events 2 • 16 days
|
|
Ear and labyrinth disorders
Strengthening rhinorrhea
|
7.5%
3/40 • Number of events 3 • 16 days
|
5.0%
2/40 • Number of events 2 • 16 days
|
12.5%
5/40 • Number of events 5 • 16 days
|
|
Ear and labyrinth disorders
Increased sneezing
|
5.0%
2/40 • Number of events 2 • 16 days
|
0.00%
0/40 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
|
Ear and labyrinth disorders
Sneezing
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
|
Nervous system disorders
Headache
|
5.0%
2/40 • Number of events 2 • 16 days
|
5.0%
2/40 • Number of events 2 • 16 days
|
10.0%
4/40 • Number of events 4 • 16 days
|
|
Nervous system disorders
Strengthening headache
|
5.0%
2/40 • Number of events 2 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • Number of events 1 • 16 days
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
|
Musculoskeletal and connective tissue disorders
Strengthening myalgia
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
5.0%
2/40 • Number of events 2 • 16 days
|
|
Eye disorders
Tearing
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
|
General disorders
Hypothermia
|
0.00%
0/40 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
0.00%
0/40 • 16 days
|
|
General disorders
Fever
|
7.5%
3/40 • Number of events 4 • 16 days
|
5.0%
2/40 • Number of events 2 • 16 days
|
5.0%
2/40 • Number of events 3 • 16 days
|
|
General disorders
Chill increase
|
2.5%
1/40 • Number of events 1 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
|
General disorders
Malaise
|
2.5%
1/40 • Number of events 1 • 16 days
|
0.00%
0/40 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
|
General disorders
Chills
|
2.5%
1/40 • Number of events 1 • 16 days
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
|
General disorders
Periodic temperature rise
|
0.00%
0/40 • 16 days
|
0.00%
0/40 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
|
General disorders
Fever increase
|
10.0%
4/40 • Number of events 4 • 16 days
|
7.5%
3/40 • Number of events 3 • 16 days
|
5.0%
2/40 • Number of events 3 • 16 days
|
|
General disorders
Strengthening ailments
|
12.5%
5/40 • Number of events 5 • 16 days
|
2.5%
1/40 • Number of events 1 • 16 days
|
7.5%
3/40 • Number of events 3 • 16 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place