Trial Outcomes & Findings for COVID-19 Study of Safety and Tolerability of Alvelestat (NCT NCT04539795)
NCT ID: NCT04539795
Last Updated: 2023-01-19
Results Overview
Safety Outcome Assessment
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
to day 60
Results posted on
2023-01-19
Participant Flow
Participant milestones
| Measure |
Placebo Oral Tablet
placebo
Placebo: oral tablet
|
Alvelestat Oral Tablet
MPH966
Alvelestat: oral tablet
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID-19 Study of Safety and Tolerability of Alvelestat
Baseline characteristics by cohort
| Measure |
Placebo
n=7 Participants
placebo
Placebo: oral tablet
|
Alvelestat
n=8 Participants
MPH966
Alvelestat: oral tablet
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
42 years
STANDARD_DEVIATION 23.9 • n=7 Participants
|
47.8 years
STANDARD_DEVIATION 20.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 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
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: to day 60Safety Outcome Assessment
Outcome measures
| Measure |
Placebo
n=7 Participants
placebo
Placebo: oral tablet
|
Alvelestat
n=8 Participants
Alvelestat
|
|---|---|---|
|
Numbers and % of Subjects Who Experience at Least 1 Treatment-emergent Adverse Event
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Randomization through Day 10 or hospital discharge, whichever was shorter.Change in blood markers of NETosis
Outcome measures
| Measure |
Placebo
n=7 Participants
placebo
Placebo: oral tablet
|
Alvelestat
n=8 Participants
Alvelestat
|
|---|---|---|
|
Effect of Alvelestat on Blood Pharmacodynamic Biomarkers of NETosis
Cell-free DNA
|
-1.35 log2(ng/ml)
Standard Deviation 2.66
|
0.16 log2(ng/ml)
Standard Deviation 1.38
|
|
Effect of Alvelestat on Blood Pharmacodynamic Biomarkers of NETosis
Citrullinated histone H3
|
-.43 log2(ng/ml)
Standard Deviation 1.94
|
.73 log2(ng/ml)
Standard Deviation 1.36
|
|
Effect of Alvelestat on Blood Pharmacodynamic Biomarkers of NETosis
MPO-DNA
|
-.45 log2(ng/ml)
Standard Deviation 1.01
|
.53 log2(ng/ml)
Standard Deviation .48
|
|
Effect of Alvelestat on Blood Pharmacodynamic Biomarkers of NETosis
MPO
|
-.39 log2(ng/ml)
Standard Deviation 2.19
|
.01 log2(ng/ml)
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Randomization through Day 10 or hospital discharge, whichever was shorter.Change in blood markers of inflammation
Outcome measures
| Measure |
Placebo
n=7 Participants
placebo
Placebo: oral tablet
|
Alvelestat
n=8 Participants
Alvelestat
|
|---|---|---|
|
Effect of Alvelestat on Blood Pharmacodynamic Biomarkers of Inflammation
IL-6
|
0.14 log2(pg/ml)
Standard Deviation 2.37
|
-1.61 log2(pg/ml)
Standard Deviation 2.16
|
|
Effect of Alvelestat on Blood Pharmacodynamic Biomarkers of Inflammation
IL-8
|
0.56 log2(pg/ml)
Standard Deviation 1.05
|
-0.45 log2(pg/ml)
Standard Deviation 0.76
|
|
Effect of Alvelestat on Blood Pharmacodynamic Biomarkers of Inflammation
TNFa
|
0.61 log2(pg/ml)
Standard Deviation 0.90
|
-0.19 log2(pg/ml)
Standard Deviation 0.58
|
|
Effect of Alvelestat on Blood Pharmacodynamic Biomarkers of Inflammation
IL-1b
|
-1.37 log2(pg/ml)
Standard Deviation 1.63
|
0.06 log2(pg/ml)
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Randomization through Day 10 or hospital discharge, whichever was shorter.Change in blood markers of d-dimer
Outcome measures
| Measure |
Placebo
n=7 Participants
placebo
Placebo: oral tablet
|
Alvelestat
n=8 Participants
Alvelestat
|
|---|---|---|
|
Effect of Alvelestat on Blood Pharmacodynamic Biomarkers of D-dimer
|
-0.08 log2(ng/ml)
Standard Deviation 0.90
|
-1.92 log2(ng/ml)
Standard Deviation 2.89
|
SECONDARY outcome
Timeframe: Randomization through Day 10 or hospital discharge, whichever was shorter.Change in blood markers of desmosine
Outcome measures
| Measure |
Placebo
n=7 Participants
placebo
Placebo: oral tablet
|
Alvelestat
n=8 Participants
Alvelestat
|
|---|---|---|
|
Effect of Alvelestat on Blood Pharmacodynamic Biomarkers of Desmosine
|
-0.04 log2(ng/ml)
Standard Deviation 1.14
|
0.54 log2(ng/ml)
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: to Day 90Outcome measures
| Measure |
Placebo
n=7 Participants
placebo
Placebo: oral tablet
|
Alvelestat
n=8 Participants
Alvelestat
|
|---|---|---|
|
Mortality Rate
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Alvelestat
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=7 participants at risk
Placebo
|
Alvelestat
n=8 participants at risk
Alvelestat
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/7 • 90 days
|
12.5%
1/8 • Number of events 1 • 90 days
|
Other adverse events
| Measure |
Placebo
n=7 participants at risk
Placebo
|
Alvelestat
n=8 participants at risk
Alvelestat
|
|---|---|---|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • 90 days
|
50.0%
4/8 • Number of events 4 • 90 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Number of events 1 • 90 days
|
12.5%
1/8 • Number of events 1 • 90 days
|
|
Vascular disorders
Epistaxis
|
14.3%
1/7 • Number of events 1 • 90 days
|
0.00%
0/8 • 90 days
|
|
Cardiac disorders
atrial fibrillation
|
14.3%
1/7 • Number of events 1 • 90 days
|
0.00%
0/8 • 90 days
|
Additional Information
Dr. Wells (Study PI)
University of Alabama at Birmingham (UAB)
Phone: 205-934-5555
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place