Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19
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|ClinicalTrials.gov Identifier: NCT04411667|
Recruitment Status : Completed
First Posted : June 2, 2020
Results First Posted : June 25, 2021
Last Update Posted : June 25, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Sars-CoV2||Drug: Octagam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.|
|Masking:||None (Open Label)|
|Official Title:||Randomized Open Label Study of Standard of Care Plus Intravenous Immunoglobulin (IVIG) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection|
|Actual Study Start Date :||April 28, 2020|
|Actual Primary Completion Date :||June 23, 2020|
|Actual Study Completion Date :||June 23, 2020|
Experimental: 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.
Standard of Care plus Octagam infusion for 3 days.
Other Name: IVIG
No Intervention: Group B (SOC)
Standard of Care
- Mechanical Ventilation [ Time Frame: 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
- Oxygen Therapy [ Time Frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days ]Number of days requiring oxygen therapy
- Length of Stay [ Time Frame: 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Confirmed COVID-19 positive test result (including presumptive positive).
- Requiring ≥4 liters/min O2 nasal cannula to maintain oxygen saturation ≥ 92%, but not mechanically ventilated
- Age ≥18 years old.
- Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail.
- Able to read/write/speak English or Spanish fluently.
- Subjects must have the capacity to provide consent or an appropriate Legally Authorized Representative (LAR) to provide informed consent.
provide informed consent, and provide authorization of use and disclosure of personal health information.
- Negative pregnancy test for women of childbearing potential.
- Severe allergy to any IVIG product formulation
- History of DVT, PE, thromboembolic stroke or other thrombotic events
- Hypersensitivity to corn. Octagam® contains maltose which is a sugar derived from corn.
- Uncontrolled hypertension (SBP>180 mm Hg or DBP>120mmHg)
- Active participant in another research treatment study
- Mechanically ventilated patient
- Code status is Do Not Resuscitate or Do Not Intubate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04411667
|United States, California|
|Sharp Grossmont Hospital|
|La Mesa, California, United States, 91942|
|Sharp Memorial Hospital|
|San Diego, California, United States, 92123|
|Principal Investigator:||George Sakoulas, MD||Sharp HealthCare|
Documents provided by George Sakoulas, MD, Sharp HealthCare:
|Responsible Party:||George Sakoulas, MD, Infectious Disease Specialist, Sharp HealthCare|
|Other Study ID Numbers:||
2004902 ( Other Identifier: Sharp HealthCare Institutional Review Board (SHC IRB) )
|First Posted:||June 2, 2020 Key Record Dates|
|Results First Posted:||June 25, 2021|
|Last Update Posted:||June 25, 2021|
|Last Verified:||June 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases
Rho(D) Immune Globulin
Physiological Effects of Drugs