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
Overview
- Phase
- Phase 4
- Intervention
- IVIG
- Conditions
- Covid19
- Sponsor
- Sharp HealthCare
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Hospital length of stay
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
George Sakoulas, MD
Infectious Disease Specialist
Sharp HealthCare
Eligibility Criteria
Inclusion Criteria
- •Confirmed COVID-19 positive test result
- •Initiation of the first dose of IVIG within 72 hours of mechanical ventilation.
- •Age \>18 years old.
- •Consenting next of kin having access to an electronic device that is able to access DocuSign® online and email for consenting.
- •Subjects or their proxy must have the ability to understand the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.
Exclusion Criteria
- •Superimposed bacterial pneumonia or bacteremia
- •Severe allergy to any IVIG product formulation
- •Hypersensitivity to corn
- •Uncontrolled hypertension (SBP\>180 mm Hg or DBP\>120mmHg)
- •Active participant in another research treatment study
- •Advanced dementia
- •Severe renal disease (CrCl\< 20 mL/min)
- •Active cancer malignancy
- •Active treatment with cancer chemotherapy or immunotherapy
- •Congestive heart failure clinically or by history (EF\< 25%)
Arms & Interventions
IVIG
IVIG 0.5gram/kg IVPB using actual body weight daily x 4 days
Intervention: IVIG
Outcomes
Primary Outcomes
Hospital length of stay
Time Frame: Up to 60 days
Assess hospital length of stay after mechanical ventilation
Secondary Outcomes
- Human metabolome and proteome(Up to 60 days)