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IVIG in Patients With Severe COVID-19 Requiring Mechanical Ventilation

Primary Purpose

Covid19, SARS-CoV Infection

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

IVIG

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Sharp Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IVIG

Arm Description

IVIG 0.5gram/kg IVPB using actual body weight daily x 4 days

Outcomes

Primary Outcome Measures

Hospital length of stay

Assess hospital length of stay after mechanical ventilation

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04616001

First Posted

November 2, 2020

Last Updated

November 2, 2020

Sponsor

Sharp HealthCare

1. Study Identification

Unique Protocol Identification Number

NCT04616001

Brief Title

IVIG in Patients With Severe COVID-19 Requiring Mechanical Ventilation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2020 (Anticipated)

Primary Completion Date

June 30, 2021 (Anticipated)

Study Completion Date

June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sharp HealthCare

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, SARS-CoV Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

Open label, single group, pilot study

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IVIG

Arm Type

Experimental

Arm Description

IVIG 0.5gram/kg IVPB using actual body weight daily x 4 days

Intervention Type

Drug

Intervention Name(s)

IVIG

Other Intervention Name(s)

Octagam

Intervention Description

Patients will receive IVIG daily for four days.

Primary Outcome Measure Information:

Title

Hospital length of stay

Description

Assess hospital length of stay after mechanical ventilation

Time Frame

Up to 60 days

Secondary Outcome Measure Information:

Title

Human metabolome and proteome

Description

Time Frame

Up to 60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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%) 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kathryn Miller

Phone

858-939-7161

kathryn.miller@sharp.com

First Name & Middle Initial & Last Name or Official Title & Degree

Matthew Geriak, PharmD

Phone

858-939-3717

matthew.geriak@sharp.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George Sakoulas, MD

Organizational Affiliation

Sharp HealthCare

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sharp Memorial Hospital

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathryn Miller

Phone

858-939-7161

kathryn.miller@sharp.com

12. IPD Sharing Statement

Plan to Share IPD

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IVIG in Patients With Severe COVID-19 Requiring Mechanical Ventilation

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