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

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.

Study Overview

• Status: Unknown
• Conditions: Covid19; SARS-CoV Infection
• Intervention / Treatment: Drug: IVIG

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kathryn Miller; Phone Number: 858-939-7161; Email: kathryn.miller@sharp.com
• Study Contact Backup: Name: Matthew Geriak, PharmD; Phone Number: 858-939-3717; Email: matthew.geriak@sharp.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
      • Contact: Kathryn Miller; Phone Number: 858-939-7161; Email: kathryn.miller@sharp.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Confirmed COVID-19 positive test result
2. Initiation of the first dose of IVIG within 72 hours of mechanical ventilation.
3. Age >18 years old.
4. Consenting next of kin having access to an electronic device that is able to access DocuSign® online and email for consenting.
5. 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:

1. Superimposed bacterial pneumonia or bacteremia
2. Severe allergy to any IVIG product formulation
3. Hypersensitivity to corn
4. Uncontrolled hypertension (SBP>180 mm Hg or DBP>120mmHg)
5. Active participant in another research treatment study
6. Advanced dementia
7. Severe renal disease (CrCl< 20 mL/min)
8. Active cancer malignancy
9. Active treatment with cancer chemotherapy or immunotherapy
10. Congestive heart failure clinically or by history (EF< 25%)
11. Prior receipt during admission of any other investigational agent (eg. convalescent plasma, tocilizumab)
12. Venous or arterial thrombosis < 90 days prior

13. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVIG; IVIG 0.5gram/kg IVPB using actual body weight daily x 4 days	Drug: IVIG; Patients will receive IVIG daily for four days.; Other Names: Octagam

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sharp HealthCare
• Investigators: Principal Investigator: George Sakoulas, MD, Sharp HealthCare

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19; Infections
• Other Study ID Numbers: COVID-IVIG VENT; 2010902 (Other Identifier: Sharp HealthCare Institutional Review Board (SHC IRB))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No