Clinical trial NCT04616001: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Covid19
SARS-CoV Infection
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, single group, pilot study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Hospital length of stay
timeFrame: Up to 60 days
Secondary outcomes:
measure: Human metabolome and proteome
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
Study officials:
affiliation: Sharp HealthCare
name: George Sakoulas, MD
role: PRINCIPAL_INVESTIGATOR
References: