Trial Outcomes & Findings for Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19 (NCT NCT04411667)
NCT ID: NCT04411667
Last Updated: 2021-06-25
Results Overview
Number of subjects requiring mechanical ventilation due to respiratory failure
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Results posted on
2021-06-25
Participant Flow
Participant milestones
| Measure |
Group A (Study Drug+SOC)
Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.
Octagam: Standard of Care plus Octagam infusion for 3 days.
|
Group B (SOC)
Standard of Care
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group A (Study Drug+SOC)
Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.
Octagam: Standard of Care plus Octagam infusion for 3 days.
|
Group B (SOC)
Standard of Care
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19
Baseline characteristics by cohort
| Measure |
Group A (Study Drug+SOC)
n=16 Participants
Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.
Octagam: Standard of Care plus Octagam infusion for 3 days.
|
Group B (SOC)
n=17 Participants
Standard of Care
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=99 Participants
|
51 years
n=107 Participants
|
56 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Body Mass Index
|
32.5 kg/m^2
n=99 Participants
|
34.9 kg/m^2
n=107 Participants
|
33.6 kg/m^2
n=206 Participants
|
|
Comorbidities
Diabetes mellitus
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Comorbidities
Hypertension
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Comorbidities
Chronic kidney disease
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Comorbidities
Coronary artery disease
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Comorbidities
Congestive heart failure
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Comorbidities
Asthma/chronic obstructive pulmonary disease
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Comorbidities
Current smoker
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Comorbidities
Former smoker
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Comorbidities
Immunocompromised
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Comorbidities Continued (HbA1c)
|
10.1 % glycosylated hemoglobin
n=99 Participants
|
6.4 % glycosylated hemoglobin
n=107 Participants
|
8.1 % glycosylated hemoglobin
n=206 Participants
|
|
Other Coronavirus Disease 2019 Therapies
Remdesivir
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Other Coronavirus Disease 2019 Therapies
Convalescent plasma
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Other Coronavirus Disease 2019 Therapies
Glucocorticoids
|
16 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 daysNumber of subjects requiring mechanical ventilation due to respiratory failure
Outcome measures
| Measure |
Group A (Study Drug+SOC)
n=16 Participants
Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.
Octagam: Standard of Care plus Octagam infusion for 3 days.
|
Group B (SOC)
n=17 Participants
Standard of Care
|
|---|---|---|
|
Mechanical Ventilation
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 daysPopulation: This data was not collected although it was originally intended to be an outcome measure
Number of days requiring oxygen therapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 daysNumber of days in hospital
Outcome measures
| Measure |
Group A (Study Drug+SOC)
n=16 Participants
Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.
Octagam: Standard of Care plus Octagam infusion for 3 days.
|
Group B (SOC)
n=17 Participants
Standard of Care
|
|---|---|---|
|
Length of Stay
|
12 days
Interval 6.0 to 29.0
|
17 days
Interval 4.0 to 60.0
|
Adverse Events
Group A (Study Drug+SOC)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 1 deaths
Group B (SOC)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A (Study Drug+SOC)
n=16 participants at risk
Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated.
Octagam: Standard of Care plus Octagam infusion for 3 days.
|
Group B (SOC)
n=17 participants at risk
Standard of Care
|
|---|---|---|
|
General disorders
Hyperglycemia
|
18.8%
3/16 • Number of events 3 • from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
|
11.8%
2/17 • Number of events 2 • from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
|
|
General disorders
Thrombocytosis
|
6.2%
1/16 • Number of events 1 • from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
|
5.9%
1/17 • Number of events 1 • from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
|
|
General disorders
Anemia
|
0.00%
0/16 • from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
|
17.6%
3/17 • Number of events 3 • from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
|
|
General disorders
Leukocytosis
|
6.2%
1/16 • Number of events 1 • from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
|
5.9%
1/17 • Number of events 1 • from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
|
|
General disorders
Elevated D-Dimer
|
12.5%
2/16 • Number of events 2 • from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
|
11.8%
2/17 • Number of events 2 • from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute Hypoxic Respiratory Failure
|
6.2%
1/16 • Number of events 1 • from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
|
5.9%
1/17 • Number of events 1 • from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
|
|
General disorders
Elevated Liver Function Tests
|
18.8%
3/16 • Number of events 3 • from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
|
0.00%
0/17 • from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
|
Additional Information
Matthew Geriak, PharmD / Research Pharmacist
Sharp HealthCare
Phone: 8589393717
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place