Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- SARS COV2
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 1:1. The goal of this study is to identify whether or not IVIG can halt the progression to respirato...
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 1:1. The goal of this study is to identify whether or not IVIG can halt the progression to respiratory failure requiring mechanical ventilation in subjects admitted to the hospital with confirmed COVID-19. The addition of IVIG to the standard of care treatment for these patients may be beneficial in abating acute lung injury in subjects with SARSCoV-2 induced hypoxia that results in organ injury.
Tracking Information
- NCT #
- NCT04411667
- Collaborators
- Octapharma
- Investigators
- Principal Investigator: George Sakoulas, MD Sharp HealthCare
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