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| ID | Type | Description | Link |
|---|---|---|---|
| 2010902 | Other Identifier | Sharp HealthCare Institutional Review Board (SHC IRB) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIG | Experimental | IVIG 0.5gram/kg IVPB using actual body weight daily x 4 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIG | Drug | Patients will receive IVIG daily for four days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay | Assess hospital length of stay after mechanical ventilation | Up to 60 days |
| 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 |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Miller | Contact | 858-939-7161 | kathryn.miller@sharp.com | |
| Matthew Geriak, PharmD | Contact | 858-939-3717 | matthew.geriak@sharp.com |
| Name | Affiliation | Role |
|---|---|---|
| George Sakoulas, MD | Sharp HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| C495669 | Octagam |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Open label, single group, pilot study
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |