NCT04616001

IVIG in Patients With Severe COVID-19 Requiring Mechanical Ventilation

Pilot Study of the Use of IVIG in Patients With Severe COVID-19 Infections Requiring Mechanical Ventilation and to Assess Their Biological Responses to IVIG Therapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Pilot Study is to establish a hypothesis of whether or not intravenous immunoglobulin (IVIG) may impact the hospital length of stay, if started within 48 of mechanical ventilation in patients infected with SARS-CoV-2 virus.

Detailed description

This is an investigator initiated, open label, 1 arm study to observe the impact of length of hospitalization by starting IVIG administration within 48 hours of mechanical ventilation. The exploratory objective is to analyze the blood before, during and after IVIG administration. The blood will be analyzed for the production of inflammatory and non-inflammatory cytokines, biomarkers for endothelial injury and biomarkers for coagulation via Mass Spectrometry.

Conditions

• Covid19
• SARS-CoV Infection

Interventions

Type	Name	Description
DRUG	IVIG	Patients will receive IVIG daily for four days.

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2020-11-04
• Last updated: 2020-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study