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| ID | Type | Description | Link |
|---|---|---|---|
| 2004902 | Other Identifier | Sharp HealthCare Institutional Review Board (SHC IRB) |
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| Name | Class |
|---|---|
| Octapharma | INDUSTRY |
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The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce respiratory complications (respiratory failure and need for a ventilator) caused by coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized IVIG for patients infected with the influenza virus. The investigator wants to find out if IVIG is equally effective in COVID-19 infection patients, and if IVIG will give the immune system some help to clear the infection naturally.
This is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding IVIG to the Standard of Care (SOC) to the SOC without IVIG. Randomization will be 1:1. The goal of this study is to identify whether or not IVIG can halt the progression to respiratory failure requiring mechanical ventilation in subjects admitted to the hospital with confirmed COVID-19. The addition of IVIG to the standard of care treatment for these patients may be beneficial in abating acute lung injury in subjects with SARSCoV-2 induced hypoxia that results in organ injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (study drug+SOC) | Experimental | Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated. |
|
| Group B (SOC) | No Intervention | Standard of Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octagam | Drug | Standard of Care plus Octagam infusion for 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical Ventilation | Number of subjects requiring mechanical ventilation due to respiratory failure | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Therapy | Number of days requiring oxygen therapy | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days |
| Length of Stay |
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Inclusion Criteria:
provide informed consent, and provide authorization of use and disclosure of personal health information.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Sakoulas, MD | Sharp HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Grossmont Hospital | La Mesa | California | 91942 | United States | ||
| Sharp Memorial Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (Study Drug+SOC) | Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated. Octagam: Standard of Care plus Octagam infusion for 3 days. |
| FG001 | Group B (SOC) | Standard of Care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A (Study Drug+SOC) | Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated. Octagam: Standard of Care plus Octagam infusion for 3 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mechanical Ventilation | Number of subjects requiring mechanical ventilation due to respiratory failure | Posted | Count of Participants | Participants | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days |
|
from date of patient enrollment to date of patient discharge or date of death, whichever came first, assessed up to 45 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A (Study Drug+SOC) | Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated. Octagam: Standard of Care plus Octagam infusion for 3 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated D-Dimer | General disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Geriak, PharmD / Research Pharmacist | Sharp HealthCare | 8589393717 | matthew.geriak@sharp.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2020 | May 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C495669 | Octagam |
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.
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Number of days in hospital
| from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 days |
| San Diego |
| California |
| 92123 |
| United States |
| BG001 | Group B (SOC) | Standard of Care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Full Range | kg/m^2 |
|
| Comorbidities | Count of Participants | Participants |
|
| Comorbidities Continued (HbA1c) | Mean | Full Range | % glycosylated hemoglobin |
|
| Other Coronavirus Disease 2019 Therapies | Count of Participants | Participants |
|
Standard of Care
|
|
| Secondary | Oxygen Therapy | Number of days requiring oxygen therapy | This data was not collected although it was originally intended to be an outcome measure | Posted | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days |
|
|
| Secondary | Length of Stay | Number of days in hospital | Posted | Median | Full Range | days | from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 days |
|
|
|
| 1 |
| 16 |
| 0 |
| 16 |
| 7 |
| 16 |
| EG001 | Group B (SOC) | Standard of Care | 3 | 17 | 0 | 17 | 8 | 17 |
| Acute Hypoxic Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Elevated Liver Function Tests | General disorders | Systematic Assessment |
|
| Hyperglycemia | General disorders | Systematic Assessment |
|
| Thrombocytosis | General disorders | Systematic Assessment |
|
| Anemia | General disorders | Systematic Assessment |
|
| Leukocytosis | General disorders | Systematic Assessment |
|
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| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract 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 |