IVIG in Patients With Severe COVID-19 Requiring Mechanical Ventilation

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04616001
• Other study ID #: COVID-IVIG VENT
• Secondary ID: 2010902
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2020
• Source: Sharp HealthCare
• Contact: Kathryn Miller
• Phone: 858-939-7161
• Email: kathryn.miller[@]sharp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronavirus Infections
• Covid19
• Infection
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• IVIG
Patients will receive IVIG daily for four days.

Locations

Country	Name	City	State
United States	Sharp Memorial Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Sharp HealthCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital length of stay	Assess hospital length of stay after mechanical ventilation	Up to 60 days
Secondary	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