Status:
COMPLETED
Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19
Lead Sponsor:
George Sakoulas, MD
Collaborating Sponsors:
Octapharma
Conditions:
Sars-CoV2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
This is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding IVIG to the Standard of Care (SOC) to the SOC without IVIG. Randomization will be ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04411667
Start Date
April 28 2020
End Date
June 23 2020
Last Update
June 25 2021
Active Locations (2)
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1
Sharp Grossmont Hospital
La Mesa, California, United States, 91942
2
Sharp Memorial Hospital
San Diego, California, United States, 92123