Trial Outcomes & Findings for Sarilumab for Patients With Moderate COVID-19 Disease (NCT NCT04359901)
NCT ID: NCT04359901
Last Updated: 2023-12-06
Results Overview
Composite outcome of number of participants with intubation or death
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
within 14 Days of enrollment
Results posted on
2023-12-06
Participant Flow
Participant milestones
| Measure |
Standard of Care Plus Subcutaneous Sarilumab
Standard of care as directed by the treating clinicians, plus sarilumab 400 mg subcutaneous injection. Sarilumab is provided in prefilled syringes/pens containing 200 mg each as is used clinically, and both injections will be given as soon as is convenient after the patient has decided to enroll.
SARILUMAB: Single dose of 400 mg subcutaneous sarilumab
|
Standard of Care
Standard of care as directed by the treating clinicians.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
30
|
|
Overall Study
Follow up to 14 Days
|
15
|
28
|
|
Overall Study
Follow up to 30 Days
|
14
|
27
|
|
Overall Study
COMPLETED
|
14
|
27
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Standard of Care Plus Subcutaneous Sarilumab
Standard of care as directed by the treating clinicians, plus sarilumab 400 mg subcutaneous injection. Sarilumab is provided in prefilled syringes/pens containing 200 mg each as is used clinically, and both injections will be given as soon as is convenient after the patient has decided to enroll.
SARILUMAB: Single dose of 400 mg subcutaneous sarilumab
|
Standard of Care
Standard of care as directed by the treating clinicians.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Death
|
6
|
2
|
Baseline Characteristics
Sarilumab for Patients With Moderate COVID-19 Disease
Baseline characteristics by cohort
| Measure |
Standard of Care Plus Subcutaneous Sarilumab
n=20 Participants
Standard of care as directed by the treating clinicians, plus sarilumab 400 mg subcutaneous injection. Sarilumab is provided in prefilled syringes/pens containing 200 mg each as is used clinically, and both injections will be given as soon as is convenient after the patient has decided to enroll.
SARILUMAB: Single dose of 400 mg subcutaneous sarilumab
|
Standard of Care
n=30 Participants
Standard of care as directed by the treating clinicians.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.8 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
70.7 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
72.3 years
STANDARD_DEVIATION 32.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
45 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
30 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
BMI
|
32.4 kilograms per meter squared
STANDARD_DEVIATION 6.4 • n=5 Participants
|
32.9 kilograms per meter squared
STANDARD_DEVIATION 6.9 • n=7 Participants
|
32.7 kilograms per meter squared
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Smoking status
Current smoker
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Smoking status
Former smoker
|
11 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Smoking status
Never smoker
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Smoking status
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Brescia COVID respiratory severity score
|
1.8 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
1.7 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
1.7 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Body temperature
|
98.3 Degrees Fahrenheit
STANDARD_DEVIATION 1.3 • n=5 Participants
|
98.3 Degrees Fahrenheit
STANDARD_DEVIATION 1.2 • n=7 Participants
|
98.3 Degrees Fahrenheit
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Minimum oxygen saturation on room air
|
93.4 Percent oxygen saturation
STANDARD_DEVIATION 2.7 • n=5 Participants
|
93.7 Percent oxygen saturation
STANDARD_DEVIATION 2.9 • n=7 Participants
|
93.5 Percent oxygen saturation
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Use of oxygen supplementation
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Oxygen Concentrator flow rate
|
2.7 L/min
STANDARD_DEVIATION 1.3 • n=5 Participants
|
2.6 L/min
STANDARD_DEVIATION 0.8 • n=7 Participants
|
2.7 L/min
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Non-invasive ventilatory support
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 14 Days of enrollmentComposite outcome of number of participants with intubation or death
Outcome measures
| Measure |
Standard of Care Plus Subcutaneous Sarilumab
n=20 Participants
Standard of care as directed by the treating clinicians, plus sarilumab 400 mg subcutaneous injection. Sarilumab is provided in prefilled syringes/pens containing 200 mg each as is used clinically, and both injections will be given as soon as is convenient after the patient has decided to enroll.
SARILUMAB: Single dose of 400 mg subcutaneous sarilumab
|
Standard of Care
n=30 Participants
Standard of care as directed by the treating clinicians.
|
|---|---|---|
|
Number of Participants With Intubation or Death
|
5 Participants
|
1 Participants
|
Adverse Events
Standard of Care Plus Subcutaneous Sarilumab
Serious events: 7 serious events
Other events: 8 other events
Deaths: 6 deaths
Standard of Care
Serious events: 5 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Standard of Care Plus Subcutaneous Sarilumab
n=20 participants at risk
Standard of care as directed by the treating clinicians, plus sarilumab 400 mg subcutaneous injection. Sarilumab is provided in prefilled syringes/pens containing 200 mg each as is used clinically, and both injections will be given as soon as is convenient after the patient has decided to enroll.
SARILUMAB: Single dose of 400 mg subcutaneous sarilumab
|
Standard of Care
n=30 participants at risk
Standard of care as directed by the treating clinicians.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oxygen desaturation
|
5.0%
1/20 • Number of events 1 • 30 days
|
0.00%
0/30 • 30 days
|
|
Renal and urinary disorders
Worsening of chronic kidney disease
|
0.00%
0/20 • 30 days
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Nervous system disorders
Delirium
|
0.00%
0/20 • 30 days
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Cardiac disorders
Heart failure
|
0.00%
0/20 • 30 days
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
15.0%
3/20 • Number of events 3 • 30 days
|
6.7%
2/30 • Number of events 2 • 30 days
|
|
General disorders
Death of unknown cause
|
5.0%
1/20 • Number of events 1 • 30 days
|
0.00%
0/30 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure, cardiac arrest
|
5.0%
1/20 • Number of events 1 • 30 days
|
0.00%
0/30 • 30 days
|
|
Renal and urinary disorders
Renal failure
|
5.0%
1/20 • Number of events 1 • 30 days
|
0.00%
0/30 • 30 days
|
Other adverse events
| Measure |
Standard of Care Plus Subcutaneous Sarilumab
n=20 participants at risk
Standard of care as directed by the treating clinicians, plus sarilumab 400 mg subcutaneous injection. Sarilumab is provided in prefilled syringes/pens containing 200 mg each as is used clinically, and both injections will be given as soon as is convenient after the patient has decided to enroll.
SARILUMAB: Single dose of 400 mg subcutaneous sarilumab
|
Standard of Care
n=30 participants at risk
Standard of care as directed by the treating clinicians.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
2/20 • Number of events 2 • 30 days
|
0.00%
0/30 • 30 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20 • Number of events 1 • 30 days
|
0.00%
0/30 • 30 days
|
|
Hepatobiliary disorders
Alanine aminotransferase elevation
|
0.00%
0/20 • 30 days
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Infections and infestations
Non-COVID related infection (Bacterial)
|
15.0%
3/20 • Number of events 3 • 30 days
|
16.7%
5/30 • Number of events 6 • 30 days
|
|
Infections and infestations
Non-COVID related infection (Fungal)
|
5.0%
1/20 • Number of events 1 • 30 days
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Infections and infestations
Oral herpes virus
|
10.0%
2/20 • Number of events 2 • 30 days
|
0.00%
0/30 • 30 days
|
|
Renal and urinary disorders
Hemodialysis
|
0.00%
0/20 • 30 days
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/20 • 30 days
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/20 • 30 days
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Cardiac disorders
ECG abnormality
|
0.00%
0/20 • 30 days
|
3.3%
1/30 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
5.0%
1/20 • Number of events 1 • 30 days
|
0.00%
0/30 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/20 • 30 days
|
3.3%
1/30 • Number of events 1 • 30 days
|
Additional Information
Westyn Branch-Elliman, MD, MMSc
VA Boston Healthcare System
Phone: 857-203-5116
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place