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=5 Participants	51 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index	32.5 kg/m^2 n=5 Participants	34.9 kg/m^2 n=7 Participants	33.6 kg/m^2 n=5 Participants
Comorbidities Diabetes mellitus	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Comorbidities Hypertension	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Comorbidities Chronic kidney disease	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Comorbidities Coronary artery disease	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Comorbidities Congestive heart failure	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Comorbidities Asthma/chronic obstructive pulmonary disease	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Comorbidities Current smoker	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Comorbidities Former smoker	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Comorbidities Immunocompromised	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Comorbidities Continued (HbA1c)	10.1 % glycosylated hemoglobin n=5 Participants	6.4 % glycosylated hemoglobin n=7 Participants	8.1 % glycosylated hemoglobin n=5 Participants
Other Coronavirus Disease 2019 Therapies Remdesivir	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Other Coronavirus Disease 2019 Therapies Convalescent plasma	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Other Coronavirus Disease 2019 Therapies Glucocorticoids	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 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

Number 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 days

Population: 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 days

Number 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 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
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

Additional Information

Matthew Geriak, PharmD / Research Pharmacist

Sharp HealthCare

Phone: 8589393717

Email: matthew.geriak@sharp.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place