Trial Outcomes & Findings for Safety, Tolerability, and Treatment Effect of Belnacasan in Patients With COVID-19 (NCT NCT05164120)
NCT ID: NCT05164120
Last Updated: 2024-09-19
Results Overview
Number of adverse events and serious adverse events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Through 60 days post enrollment
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Interventional
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
0 mg dose TID Administration Total: 0mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Treatment Effect of Belnacasan in Patients With COVID-19
Baseline characteristics by cohort
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
41.6 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
43.4 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 60 days post enrollmentPopulation: Patients reporting AEs and SAEs from the time of enrollment through Day 60
Number of adverse events and serious adverse events
Outcome measures
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Safety and Tolerability of Belnacasan
Number of adverse events
|
11 Number of AEs and SAEs
|
10 Number of AEs and SAEs
|
|
Safety and Tolerability of Belnacasan
Number of serious adverse events
|
0 Number of AEs and SAEs
|
0 Number of AEs and SAEs
|
SECONDARY outcome
Timeframe: Baseline and Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomizationPopulation: Proportion of subjects in treatment group versus placebo group, respectively, who, per symptom questionnaire, rate stuffy or runny nose, sore throat, cough, low energy or tiredness, muscle or body ache, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, shortness of breath at rest, shortness of breath with exertion, or impairment in sense of smell or taste ranging from mild to moderate.
Proportion of subjects in treatment group versus placebo group, respectively, who, per symptom questionnaire, rate stuffy or runny nose, sore throat, cough, low energy or tiredness, muscle or body ache, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, shortness of breath at rest, shortness of breath with exertion, or impairment in sense of smell or taste as mild, moderate or severe.
Outcome measures
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Diarrhea at Baseline
|
3 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Diarrhea at Day 4
|
6 Participants
|
4 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Diarrhea at Day 14
|
7 Participants
|
3 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Diarrhea at Day 21
|
4 Participants
|
3 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Diarrhea at Day 28
|
5 Participants
|
2 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Vomiting at Day 60
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Runny/stuffy nose at Day 4
|
13 Participants
|
13 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Runny/stuffy nose at Day 7
|
17 Participants
|
17 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Runny/stuffy nose at Day 14
|
12 Participants
|
10 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Runny/stuffy nose at Day 60
|
1 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Sore throat at Day 10
|
1 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Sore throat at Day 14
|
4 Participants
|
2 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Sore throat at Day 28
|
1 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Cough at Day 7
|
16 Participants
|
18 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Cough at Day 10
|
7 Participants
|
9 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Cough at Day 14
|
11 Participants
|
15 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Cough at Day 21
|
7 Participants
|
6 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Muscle or body aches at Day 7
|
13 Participants
|
13 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Muscle or body aches at Day 10
|
2 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Muscle or body aches at Day 14
|
6 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Muscle or body aches at Day 21
|
3 Participants
|
2 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Headache at Day 28
|
5 Participants
|
2 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Headache at Day 42
|
2 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Chills or shivering at Day 4
|
1 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Chills or shivering at Day 7
|
6 Participants
|
7 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Chills or shivering at Day 21
|
1 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Chills or shivering at Day 28
|
2 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Feeling hot or feverish at Day 42
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Feeling hot or feverish at Day 60
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Nausea at Day 7
|
7 Participants
|
3 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Nausea at Day 10
|
2 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Nausea at Day 21
|
0 Participants
|
2 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Vomiting at Day 14
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Vomiting at Day 21
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Vomiting at Day 28
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Vomiting at Day 42
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Diarrhea at Day 42
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Diarrhea at Day 60
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath at rest at Day 10
|
2 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath at rest at Day 14
|
4 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath at rest at Day 21
|
2 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath at rest at Day 42
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath at rest at Day 60
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath with exertion at Day 14
|
8 Participants
|
2 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath with exertion at Day 21
|
4 Participants
|
2 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath with exertion at Day 60
|
0 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of smell at Baseline
|
4 Participants
|
3 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of smell at Day 4
|
4 Participants
|
3 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of smell at Day 42
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of taste at Day 7
|
6 Participants
|
6 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of taste at Day 10
|
2 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of taste at Day 14
|
1 Participants
|
2 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of taste at Day 21
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of taste at Day 28
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of taste at Day 42
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Low energy or tiredness at Day 10
|
6 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Low energy or tiredness at Day 14
|
11 Participants
|
4 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath at rest at Day 4
|
4 Participants
|
2 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath at rest at Day 7
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Runny/stuffy nose at Baseline
|
14 Participants
|
19 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Runny/stuffy nose at Day 10
|
6 Participants
|
4 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Runny/stuffy nose at Day 21
|
5 Participants
|
3 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Runny/stuffy nose at Day 28
|
5 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Runny/stuffy nose at Day 42
|
1 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Sore throat at Baseline
|
13 Participants
|
14 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Sore throat at Day 4
|
4 Participants
|
3 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Sore throat at Day 7
|
14 Participants
|
9 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Sore throat at Day 21
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Sore throat at Day 42
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Sore throat at Day 60
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Cough at Baseline
|
17 Participants
|
18 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Cough at Day 4
|
13 Participants
|
12 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Cough at Day 28
|
6 Participants
|
3 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Cough at Day 42
|
1 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Cough at Day 60
|
1 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Low energy or tiredness at Baseline
|
17 Participants
|
14 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Low energy or tiredness at Day 4
|
10 Participants
|
7 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Low energy or tiredness at Day 7
|
18 Participants
|
17 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Low energy or tiredness at Day 21
|
6 Participants
|
3 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Low energy or tiredness at Day 28
|
7 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Low energy or tiredness at Day 42
|
1 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Low energy or tiredness at Day 60
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Muscle or body aches at Baseline
|
13 Participants
|
11 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Muscle or body aches at Day 4
|
7 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Muscle or body aches at Day 28
|
3 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Muscle or body aches at Day 42
|
1 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Muscle or body aches at Day 60
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Headache at Baseline
|
10 Participants
|
12 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Headache at Day 4
|
5 Participants
|
2 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Headache at Day 7
|
15 Participants
|
11 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Headache at Day 10
|
4 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Headache at Day 14
|
5 Participants
|
5 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Headache at Day 21
|
3 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Headache at Day 60
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Chills or shivering at Baseline
|
7 Participants
|
4 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Chills or shivering at Day 10
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Chills or shivering at Day
|
1 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Chills or shivering at Day 42
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Chills or shivering at Day 60
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Feeling hot or feverish at Baseline
|
8 Participants
|
8 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Feeling hot or feverish at Day 4
|
3 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Feeling hot or feverish at Day 7
|
10 Participants
|
10 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Feeling hot or feverish at Day 10
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Feeling hot or feverish at Day 14
|
1 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Feeling hot or feverish at Day 21
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Feeling hot or feverish at Day 28
|
1 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Nausea at Baseline
|
6 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Nausea at Day 4
|
2 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Nausea at Day 14
|
3 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Nausea at Day 28
|
2 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Nausea at Day 42
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Nausea at Day 60
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Vomiting at Baseline
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Vomiting at Day 4
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Vomiting at Day 7
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Vomiting at Day 10
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Diarrhea at Day 7
|
10 Participants
|
6 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Diarrhea at Day 10
|
3 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath at rest at Baseline
|
6 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath at rest at Day 28
|
2 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath with exertion at Baseline
|
7 Participants
|
5 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath with exertion at Day 4
|
5 Participants
|
4 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath with exertion at Day 7
|
14 Participants
|
10 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath with exertion at Day 10
|
5 Participants
|
3 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Shortness of breath with exertion at Day 28
|
2 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
1Shortness of breath with exertion at Day 42
|
1 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of smell at Day 7
|
5 Participants
|
5 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of smell at Day 10
|
1 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of smell at Day 14
|
1 Participants
|
2 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of smell at Day 21
|
1 Participants
|
1 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of smell at Day 28
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of smell at Day 60
|
0 Participants
|
0 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of taste at Baseline
|
6 Participants
|
6 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of taste at Day 4
|
5 Participants
|
5 Participants
|
|
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Impairment of sense of taste at Day 60
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomizationPopulation: Patients reporting sustained improvement of global impression at Days 4, 7, 10, 14, 21, 28, 42, and 60
Proportion of subjects in treatment group versus placebo group, respectively, who per symptom questionnaire have answered for two consecutive days: "YES" to "In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)?"; "YES" to "In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)?"
Outcome measures
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Sustained Improvement of Global Impression Rates
Day 7 "Returned to usual health"
|
5 Participants
|
5 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 10 "Returned to usual health"
|
5 Participants
|
6 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 14 "Returned to usual health"
|
11 Participants
|
12 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 28 "Returned to usual health"
|
12 Participants
|
12 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 42 "Returned to usual health"
|
16 Participants
|
16 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 60 "Returned to usual health"
|
16 Participants
|
15 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 10 "Returned to usual activity"
|
11 Participants
|
15 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 14 "Returned to usual activity"
|
15 Participants
|
17 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 42 "Returned to usual activity"
|
16 Participants
|
17 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 4 "Returned to usual health"
|
0 Participants
|
0 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 21 "Returned to usual health"
|
11 Participants
|
16 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 4 "Returned to usual activity"
|
0 Participants
|
4 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 7 "Returned to usual activity"
|
9 Participants
|
9 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 21 "Returned to usual activity"
|
15 Participants
|
17 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 28 "Returned to usual activity"
|
14 Participants
|
13 Participants
|
|
Sustained Improvement of Global Impression Rates
Day 60 "Returned to usual activity"
|
17 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Over 60 days post randomizationPopulation: The discrepancy in patient numbers (enrolled versus analyzed) is due to patients who either dropped out or have missing data.
Comparison in treatment group versus placebo group, respectively, of the number of days from randomization to the first day of achieving sustained recovery and resolution rates of common COVID-19 symptoms.
Outcome measures
| Measure |
Interventional
n=14 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=17 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Time to Sustained Recovery or Resolution of Common COVID-19 Symptoms
|
20.6 Days
Standard Deviation 18.1
|
15.4 Days
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Over 60 days post randomizationPopulation: The discrepancy in patient numbers (enrolled versus analyzed) is due to patients who either dropped out or have missing data.
Comparison in treatment group versus placebo group, respectively, of the mean number of days from randomization to the first day of achieving sustained improvement of global impression rates.
Outcome measures
| Measure |
Interventional
n=15 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=18 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Time to Sustained Improvement of Global Impression
|
10.5 Days
Standard Deviation 1.5
|
13.5 Days
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Days between enrollment and day 2 post randomizationPopulation: Patients who reported fever
Proportion of subjects in treatment group versus placebo group, respectively, who, per thermometer, experienced fever at any point between enrollment and day 2 post randomization.
Outcome measures
| Measure |
Interventional
n=17 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=19 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Rates of Fever
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Over 60 days post randomizationPopulation: Patient reported oxygenation levels over 60 days.
Average change from baseline over 60 days in percentage of blood saturation
Outcome measures
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Oxygenation Levels
|
-0.01 percentage of blood saturation
Interval -0.01 to 0.0
|
-0.01 percentage of blood saturation
Interval -0.02 to 0.01
|
SECONDARY outcome
Timeframe: 28 DaysPopulation: NOTE: One belnacasan participant had a fever (see outcome measure 6) which resolved on Day 4 an no placebo participants had a fever above 38C. NOTE: 2 placebo participants had oxygen saturation between 93 and 96% which increased to \>96% on Day 7 and no belnacasan participants had an oxygen saturation below 96%.
Comparison in treatment group versus placebo group, respectively, of the number of days from randomization to the first day of achieving sustained (i.e., at least 2 days) resolution of fever for subjects who presented with fever at any point between enrollment and day 2 post randomization; with temperature \<38C or \>=38C experienced in total during the first 28 days post randomization; from randomization to the first day post randomization of achieving oxygenation of SpO2\>=96% in room air when resting for subjects who presented with SpO2\>93% and \<96% in room air, when resting, at enrollment; with oxygenation of SpO2\>= 96% or SpO2\>93% in room air, when resting, in total during the first 28 days post randomization.
Outcome measures
| Measure |
Interventional
n=1 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=2 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Time in Days to Normalization of Fever and Oxygenation Levels.
Time in days to normalization of fever
|
4 Days
Standard Deviation 0.00
|
—
|
|
Time in Days to Normalization of Fever and Oxygenation Levels.
Time in days to normalization of oxygenation level
|
—
|
7 Days
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Days 14, 28 and 60 post randomizationPopulation: The number of treatment group, versus placebo group, respectively, who had COVID-related: emergency department visit, hospitalization, required oxygen, required an ICU visit, required ventilation, or died as of Days 14, 28, and 60.
Proportion of treatment group, versus placebo group, respectively, who per subject reporting or medical records had experienced an emergency department visit, other than at study enrollment or study visits; hospitalization for COVID-19; hospitalization for COVID-19 requiring oxygen; hospitalization for COVID-19 requiring ICU; hospitalization for COVID-19 requiring ventilation; COVID-19 related death; death; hospitalization or death on Days 14, 28, and 60.
Outcome measures
| Measure |
Interventional
n=18 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=18 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Experiences of COVID-19 Related Deterioration and Mortality
Subjects who had COVID-related: ER visit, hospitalization, ICU visit, or died by Day 14.
|
0 Number of subjects
|
0 Number of subjects
|
|
Experiences of COVID-19 Related Deterioration and Mortality
Subjects who had COVID-related: ER visit, hospitalization, ICU visit, or died by Day 60
|
0 Number of subjects
|
0 Number of subjects
|
|
Experiences of COVID-19 Related Deterioration and Mortality
Subjects who had COVID-related: ER visit, hospitalization, ICU visit, or died by Day 28
|
0 Number of subjects
|
0 Number of subjects
|
|
Experiences of COVID-19 Related Deterioration and Mortality
Subjects who required oxygen or ventilation by Day 14
|
0 Number of subjects
|
0 Number of subjects
|
|
Experiences of COVID-19 Related Deterioration and Mortality
Subjects who required oxygen or ventilation by Day 28
|
0 Number of subjects
|
0 Number of subjects
|
|
Experiences of COVID-19 Related Deterioration and Mortality
Subjects who required oxygen or ventilation by Day 60
|
0 Number of subjects
|
0 Number of subjects
|
SECONDARY outcome
Timeframe: Over 28 daysComparison of treatment group versus placebo group, respectively, in the number of subjects who following randomization experienced hospitalization for COVID-19 related deterioration: requiring oxygen, requiring ICU admission, requiring ventilation.
Outcome measures
| Measure |
Interventional
n=18 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=18 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
The Number of Subjects With COVID-19 Related Deterioration and Mortality Experiences
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomizationPopulation: Patients reported WHO 9-point scale status from baseline to scale 1 or 0 at Days 4, 7, 10, 14, 21, 28, 42, and 60
The counts of participants in the treatment group versus placebo group, respectively, who per questionnaire on WHO 9-point ordinal scale \[0: Uninfected or "no clinical or virological evidence of infection"; 1: Not hospitalized, no limitations on activities; 2: Not hospitalized, limitation on activities; 3: Hospitalized, not requiring supplemental oxygen; 4: Hospitalized, requiring supplemental oxygen; 5: Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6: Hospitalized, intubated; 7: Hospitalized, advanced life support including invasive mechanical ventilation or ECMO; 8: Death\] had experienced an improvement from scale 2 to scale 1 or 0; an improvement from scale 1 to scale 0 ; a sustainment from scale 1 to scale 1; any improvement of the scale; any worsening of the scale; scale 4 or higher; scale 6 or higher.
Outcome measures
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Changes on the WHO 9-Point Ordinal Scale
Day 4
|
3 Participants
|
6 Participants
|
|
Changes on the WHO 9-Point Ordinal Scale
Day 42
|
16 Participants
|
16 Participants
|
|
Changes on the WHO 9-Point Ordinal Scale
Day 7
|
8 Participants
|
8 Participants
|
|
Changes on the WHO 9-Point Ordinal Scale
Day 10
|
14 Participants
|
13 Participants
|
|
Changes on the WHO 9-Point Ordinal Scale
Day 14
|
14 Participants
|
11 Participants
|
|
Changes on the WHO 9-Point Ordinal Scale
Day 21
|
15 Participants
|
15 Participants
|
|
Changes on the WHO 9-Point Ordinal Scale
Day 28
|
16 Participants
|
16 Participants
|
|
Changes on the WHO 9-Point Ordinal Scale
Day 60
|
17 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Days 14, 28, and 60 post randomizationPopulation: Subjects who reported a value from 0-2 on Days 14, 28, and 60.
Comparison of treatment group versus placebo group, respectively, in the average of daily scale value (0-8) on Days 14, 28, and 60 with respect to the number of subjects who reported as uninfected (scale value of 0), had no limitations (scale value of 1), or were experiencing limitations (scale value of 2). All patients had a score ranging between 0-2. A description of the WHO 9-Point Ordinal Scale follows: 0\. Uninfected or "no clinical or virological evidence of infection" * defined as subject answering "Yes" to "In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)?" 1\. Not hospitalized, no limitations on activities * defined as subject answering "Yes" to "In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)?" 2. Not hospitalized, limitation on activities * defined as subject answering "No" to "In the past 24 hours, have you returned to your usual act
Outcome measures
| Measure |
Interventional
n=18 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=18 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Values on the WHO 9-Point Ordinal Scale
Average WHO-9 point scale value at Day 60
|
0.00 units on a scale
Standard Deviation 0.00
|
0.12 units on a scale
Standard Deviation 0.48
|
|
Values on the WHO 9-Point Ordinal Scale
Average WHO-9 point scale value at Day 14
|
1.00 units on a scale
Standard Deviation 0.69
|
0.94 units on a scale
Standard Deviation 0.87
|
|
Values on the WHO 9-Point Ordinal Scale
Average WHO-9 point scale value at Day 28
|
0.33 units on a scale
Standard Deviation 0.69
|
0.17 units on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Post treatment to Day 60Population: Patients for whom there are data for reporting "no limitations" or "uninfected"
Comparison of treatment group versus placebo group, respectively, in the mean number of days from enrollment to reporting "no limitations" or "uninfected". The discrepancy in patient numbers (enrolled versus analyzed) is due to patients who either dropped out or have missing data.
Outcome measures
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Time to Improvement on the WHO 9-Point Ordinal Scale
Days to "no limitations"
|
9.3 Days
Standard Deviation 6.1
|
7.1 Days
Standard Deviation 5.0
|
|
Time to Improvement on the WHO 9-Point Ordinal Scale
Days to "uninfected"
|
27.2 Days
Standard Deviation 14.3
|
19.0 Days
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Post treatment through Day 60Population: Mean number of days in which patients experienced "limitations", "no limitations" and "uninfected"
Comparison of treatment group versus placebo group, respectively, in the mean number of days on which subjects experienced "limitations", "no limitations", and "uninfected" post treatment (60 Days).
Outcome measures
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Mean Number of Days of Experiencing WHO 9-Point Ordinal Scale Values
Limitations
|
2.9 Days
Standard Deviation 1.8
|
2.8 Days
Standard Deviation 1.7
|
|
Mean Number of Days of Experiencing WHO 9-Point Ordinal Scale Values
No limitations
|
2.2 Days
Standard Deviation 1.9
|
1.7 Days
Standard Deviation 1.4
|
|
Mean Number of Days of Experiencing WHO 9-Point Ordinal Scale Values
Uninfected
|
3.0 Days
Standard Deviation 1.7
|
3.8 Days
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline and Days 7, 14, 21, 28Population: Number of patients who had plasma IL-6 levels measured Baseline and Days 7, 14, 21, 28.
Plasma levels of IL-6
Outcome measures
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
IL-6
Baseline
|
17.4 pg/mL
Standard Deviation 13.6
|
14.6 pg/mL
Standard Deviation 10.0
|
|
IL-6
Day 7
|
15.1 pg/mL
Standard Deviation 12.1
|
11.1 pg/mL
Standard Deviation 8.4
|
|
IL-6
Day 14
|
16.9 pg/mL
Standard Deviation 13.4
|
9.7 pg/mL
Standard Deviation 2.7
|
|
IL-6
Day 21
|
16.0 pg/mL
Standard Deviation 15.1
|
10.2 pg/mL
Standard Deviation 2.1
|
|
IL-6
Day 28
|
13.9 pg/mL
Standard Deviation 10.8
|
9.7 pg/mL
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline and Days 7, 14, 21, 28Population: Number of patients who had plasma IL-1ra levels measured Baseline and Days 7, 14, 21, 28.
Measurement of plasma IL-1ra levels
Outcome measures
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
IL-1ra
Day 21
|
40.2 pg/mL
Standard Deviation 14.5
|
23.7 pg/mL
Standard Deviation 11.2
|
|
IL-1ra
Day 28
|
37.1 pg/mL
Standard Deviation 15.8
|
25.4 pg/mL
Standard Deviation 7.6
|
|
IL-1ra
Baseline
|
37.2 pg/mL
Standard Deviation 19.0
|
32.5 pg/mL
Standard Deviation 14.4
|
|
IL-1ra
Day 7
|
31.2 pg/mL
Standard Deviation 18.1
|
26.6 pg/mL
Standard Deviation 11.4
|
|
IL-1ra
Day 14
|
34.0 pg/mL
Standard Deviation 13.6
|
23.2 pg/mL
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Baseline and Days 7, 14, 21, and 28Population: Number of patients who had plasma IL-18 levels measured Baseline and Days 7, 14, 21, 28.
Measurement of plasma levels of IL-18
Outcome measures
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
IL-18
Baseline
|
120.1 pg/mL
Standard Deviation 69.6
|
116.0 pg/mL
Standard Deviation 65.9
|
|
IL-18
Day 7
|
82.0 pg/mL
Standard Deviation 60.4
|
88.6 pg/mL
Standard Deviation 47.6
|
|
IL-18
Day 14
|
77.0 pg/mL
Standard Deviation 58.8
|
81.7 pg/mL
Standard Deviation 38.6
|
|
IL-18
Day 21
|
75.1 pg/mL
Standard Deviation 58.9
|
80.7 pg/mL
Standard Deviation 43.6
|
|
IL-18
Day 28
|
73.7 pg/mL
Standard Deviation 56.0
|
74.4 pg/mL
Standard Deviation 36.6
|
SECONDARY outcome
Timeframe: Baseline and Days 7, 14, 21, and 28Population: Number of patients who had plasma TNF-alpha levels measured Baseline and Days 7, 14, 21, 28.
Plasma levels of TNF-alpha
Outcome measures
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
TNF-alpha
Baseline
|
131.1 pg/mL
Standard Deviation 99.9
|
97.0 pg/mL
Standard Deviation 46.8
|
|
TNF-alpha
Day 7
|
124.5 pg/mL
Standard Deviation 104.2
|
97.8 pg/mL
Standard Deviation 38.9
|
|
TNF-alpha
Day 14
|
137.1 pg/mL
Standard Deviation 123.7
|
97.8 pg/mL
Standard Deviation 51.4
|
|
TNF-alpha
Day 21
|
121.4 pg/mL
Standard Deviation 112.6
|
84.0 pg/mL
Standard Deviation 46.5
|
|
TNF-alpha
Day 28
|
128.4 pg/mL
Standard Deviation 140.8
|
89.9 pg/mL
Standard Deviation 42.3
|
SECONDARY outcome
Timeframe: Baseline and Days 7, 14, 21, and 28Population: Number of patients who had plasma caspase-1 levels measured Baseline and Days 7, 14, 21, 28.
Plasma levels of caspase-1
Outcome measures
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Caspase-1
Baseline
|
97.2 pg/mL
Standard Deviation 77.6
|
115.5 pg/mL
Standard Deviation 110
|
|
Caspase-1
Day 7
|
84.7 pg/mL
Standard Deviation 95.2
|
104.4 pg/mL
Standard Deviation 92.0
|
|
Caspase-1
Day 14
|
69.5 pg/mL
Standard Deviation 74.8
|
96.4 pg/mL
Standard Deviation 105.8
|
|
Caspase-1
Day 21
|
98.7 pg/mL
Standard Deviation 120.0
|
96.4 pg/mL
Standard Deviation 105.8
|
|
Caspase-1
Day 28
|
101.6 pg/mL
Standard Deviation 150.9
|
83.4 pg/mL
Standard Deviation 66.4
|
SECONDARY outcome
Timeframe: Baseline and Days 7, 14, 21, and 28Population: Number of patients who had plasma gasdermin D levels measured Baseline and Days 7, 14, 21, 28.
Plasma levels of gasdermin D
Outcome measures
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Gasdermin D
Baseline
|
2.5 pg/mL
Standard Deviation 1.9
|
3.5 pg/mL
Standard Deviation 2.9
|
|
Gasdermin D
Day 7
|
4.0 pg/mL
Standard Deviation 2.5
|
4.9 pg/mL
Standard Deviation 4.0
|
|
Gasdermin D
Day 14
|
5.0 pg/mL
Standard Deviation 3.1
|
5.2 pg/mL
Standard Deviation 3.6
|
|
Gasdermin D
Day 21
|
6.2 pg/mL
Standard Deviation 3.1
|
7.2 pg/mL
Standard Deviation 4.0
|
|
Gasdermin D
Day 28
|
5.4 pg/mL
Standard Deviation 3.3
|
5.4 pg/mL
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline and Days 7, 14, 21, and 28Population: Number of patients who had plasma G-CSF levels measured Baseline and Days 7, 14, 21, 28.
Plasma levels of G-CSF
Outcome measures
| Measure |
Interventional
n=20 Participants
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 Participants
0 mg dose TID Administration Total: 0 mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
G-CSF
Day 28
|
122.5 pg/mL
Standard Deviation 45.3
|
102.9 pg/mL
Standard Deviation 24.1
|
|
G-CSF
Baseline
|
137.2 pg/mL
Standard Deviation 34.2
|
147.0 pg/mL
Standard Deviation 56.9
|
|
G-CSF
Day 7
|
125.0 pg/mL
Standard Deviation 29.1
|
106.6 pg/mL
Standard Deviation 36.4
|
|
G-CSF
Day 14
|
121.4 pg/mL
Standard Deviation 41.2
|
100.2 pg/mL
Standard Deviation 20.8
|
|
G-CSF
Day 21
|
114.5 pg/mL
Standard Deviation 34.9
|
103.8 pg/mL
Standard Deviation 21.3
|
Adverse Events
Interventional
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Interventional
n=20 participants at risk
900mg dose TID Administration Total: 2700mg
Belnacasan: Oral administration
|
Placebo
n=20 participants at risk
0 mg dose TID Administration Total: 0mg
Placebo: Tablet containing 0mg of API
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
10.0%
2/20 • Number of events 2 • From the time of enrollment through Day 60
|
0.00%
0/20 • From the time of enrollment through Day 60
|
Additional Information
Alexander Kroemer, MD; Khalid Kahn, MD
MedStar Health Georgetown Transplant Institute
Phone: 202-444-3700
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place