NCT04411667

Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: George Sakoulas, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (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.

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 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.

Conditions

• Sars-CoV2

Interventions

Type	Name	Description
DRUG	Octagam	Standard of Care plus Octagam infusion for 3 days.

Timeline

• Start date: 2020-04-28
• Primary completion: 2020-06-23
• Completion: 2020-06-23
• First posted: 2020-06-02
• Last updated: 2021-06-25
• Results posted: 2021-06-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study