Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19
Completed · Phase 4
Conditions studied: Sars-CoV2
In brief
The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce respiratory complications (respiratory failure and need for a ventilator) caused by coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized IVIG for patients infected with the influenza virus. The investigator wants to find out if IVIG is equally effective in COVID-19 infection patients, and if IVIG will give the immune system some help to clear the infection naturally.
Key facts
- Study ID
- NCT04411667
- Run by
- George Sakoulas, MD
- People needed
- 34
- Starts
- 2020-04-28
- Expected to finish
- 2020-06-23
- Last updated by the study team
- 2021-06-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed COVID-19 positive test result (including presumptive positive).
- Hospitalization
- 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.
You may not qualify if…
- 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
Where it is running
- Sharp Grossmont Hospital — La Mesa, California, United States
- Sharp Memorial Hospital — San Diego, California, United States
Full record on ClinicalTrials.gov
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