IVIG in Patients With Severe COVID-19 Requiring Mechanical Ventilation

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Covid19, SARS-CoV Infection

Intervention / Treatment
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* Drug: IVIG


Participation Criteria
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Eligibility Criteria
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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%) Prior receipt during admission of any other investigational agent (eg. convalescent plasma, tocilizumab) Venous or arterial thrombosis < 90 days prior Are receiving cytotoxic or biologic treatments such as TNF inhibitors, anti-interleukin-1 (IL-1), anti-IL-6 (tocilizumab or sarilumab), T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry. Note: A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening, with the following exceptions: B-cell targeted therapies: a washout period of 24 weeks or 5 half-lives (whichever is longer) TNF inhibitors: a washout period of 2 weeks or 5 half-lives (whichever is longer), and JAK inhibitor: a washout period of 1 week or 5 half-lives (whichever is longer).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label, single group, pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVIG<br>IVIG 0.5gram/kg IVPB using actual body weight daily x 4 days | Drug: IVIG<br>* Patients will receive IVIG daily for four days.<br>* Other names: Octagam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Assess hospital length of stay after mechanical ventilation | Up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human metabolome and proteome | Analyze the blood to assess the human metabolome and proteome in patients with COVID-19 receiving IVIG including production of inflammatory and anti-inflammatory cytokines, markers of endothelial injury, and coagulation using Mass Spectrometry | Up to 60 days |