Trial Outcomes & Findings for Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation (NCT NCT04399980)
NCT ID: NCT04399980
Last Updated: 2021-05-13
Results Overview
Number and percentage of subjects alive and off of oxygen at day 14
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Day 14
Results posted on
2021-05-13
Participant Flow
Participant milestones
| Measure |
Intervention
One-time Mavrilimumab infusion at 6mg/kg via IV
|
Control
One-time placebo infusion via IV
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation
Baseline characteristics by cohort
| Measure |
Intervention
n=21 Participants
One-time Mavrilimumab infusion at 6mg/kg via IV
|
Control
n=19 Participants
One-time placebo infusion via IV
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 13.49 • n=39 Participants
|
54.8 years
STANDARD_DEVIATION 18.44 • n=41 Participants
|
55.75 years
STANDARD_DEVIATION 15.97 • n=35 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
|
History of Diabetes
|
8 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
History of Hypertension
|
10 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
History of Hyperlipidemia
|
7 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 14Number and percentage of subjects alive and off of oxygen at day 14
Outcome measures
| Measure |
Intervention
n=21 Participants
One-time Mavrilimumab infusion at 6mg/kg via IV
|
Control
n=19 Participants
One-time placebo infusion via IV
|
|---|---|---|
|
Subjects Alive and Off of Oxygen at Day 14
|
12 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 28Number and percentage of subjects that are alive and without respiratory failure at Day 28
Outcome measures
| Measure |
Intervention
n=21 Participants
One-time Mavrilimumab infusion at 6mg/kg via IV
|
Control
n=19 Participants
One-time placebo infusion via IV
|
|---|---|---|
|
Number of Subjects Alive and Without Respiratory Failure at Day 28
|
20 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Day 28Number and percentage of patients that expired by Day 28
Outcome measures
| Measure |
Intervention
n=21 Participants
One-time Mavrilimumab infusion at 6mg/kg via IV
|
Control
n=19 Participants
One-time placebo infusion via IV
|
|---|---|---|
|
Mortality at Day 28
|
1 Participants
|
3 Participants
|
Adverse Events
Intervention
Serious events: 5 serious events
Other events: 12 other events
Deaths: 1 deaths
Control
Serious events: 4 serious events
Other events: 8 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Intervention
n=21 participants at risk
One-time Mavrilimumab infusion at 6kg/mg via IV
|
Control
n=19 participants at risk
One-time placebo infusion via IV
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
14.3%
3/21 • Number of events 3 • 60 days
|
10.5%
2/19 • Number of events 2 • 60 days
|
|
General disorders
Nausea
|
4.8%
1/21 • Number of events 1 • 60 days
|
0.00%
0/19 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
9.5%
2/21 • Number of events 2 • 60 days
|
5.3%
1/19 • Number of events 1 • 60 days
|
|
General disorders
Shock
|
4.8%
1/21 • Number of events 1 • 60 days
|
0.00%
0/19 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Failure
|
0.00%
0/21 • 60 days
|
5.3%
1/19 • Number of events 1 • 60 days
|
|
Investigations
Elevated WBC
|
0.00%
0/21 • 60 days
|
5.3%
1/19 • Number of events 1 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - Worsening
|
9.5%
2/21 • Number of events 2 • 60 days
|
15.8%
3/19 • Number of events 3 • 60 days
|
Other adverse events
| Measure |
Intervention
n=21 participants at risk
One-time Mavrilimumab infusion at 6kg/mg via IV
|
Control
n=19 participants at risk
One-time placebo infusion via IV
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
19.0%
4/21 • Number of events 4 • 60 days
|
15.8%
3/19 • Number of events 3 • 60 days
|
|
Blood and lymphatic system disorders
anemia
|
9.5%
2/21 • Number of events 2 • 60 days
|
10.5%
2/19 • Number of events 2 • 60 days
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/21 • 60 days
|
10.5%
2/19 • Number of events 2 • 60 days
|
|
General disorders
Headache
|
0.00%
0/21 • 60 days
|
5.3%
1/19 • Number of events 1 • 60 days
|
|
Hepatobiliary disorders
Liver Dysfunction
|
14.3%
3/21 • Number of events 3 • 60 days
|
0.00%
0/19 • 60 days
|
|
General disorders
Shock
|
9.5%
2/21 • Number of events 2 • 60 days
|
5.3%
1/19 • Number of events 1 • 60 days
|
|
Blood and lymphatic system disorders
Pulmonary Embolism
|
9.5%
2/21 • Number of events 2 • 60 days
|
5.3%
1/19 • Number of events 1 • 60 days
|
|
Cardiac disorders
Hypotension
|
0.00%
0/21 • 60 days
|
5.3%
1/19 • Number of events 1 • 60 days
|
|
Investigations
Hypophosphatemia
|
4.8%
1/21 • Number of events 1 • 60 days
|
0.00%
0/19 • 60 days
|
|
Blood and lymphatic system disorders
Clot
|
4.8%
1/21 • Number of events 1 • 60 days
|
5.3%
1/19 • Number of events 1 • 60 days
|
|
Investigations
Elevated Ferritin
|
0.00%
0/21 • 60 days
|
5.3%
1/19 • Number of events 1 • 60 days
|
|
Investigations
Elevated CRP
|
0.00%
0/21 • 60 days
|
5.3%
1/19 • Number of events 1 • 60 days
|
|
Nervous system disorders
Delirium
|
4.8%
1/21 • Number of events 1 • 60 days
|
5.3%
1/19 • Number of events 1 • 60 days
|
|
Hepatobiliary disorders
Worsening D Dimer
|
0.00%
0/21 • 60 days
|
5.3%
1/19 • Number of events 1 • 60 days
|
|
Infections and infestations
Fever
|
0.00%
0/21 • 60 days
|
5.3%
1/19 • Number of events 1 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
14.3%
3/21 • Number of events 3 • 60 days
|
10.5%
2/19 • Number of events 2 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Syndrome
|
14.3%
3/21 • Number of events 3 • 60 days
|
21.1%
4/19 • Number of events 4 • 60 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place