IVIG in Patients With Severe COVID-19 Requiring Mechanical Ventilation
NCT ID: NCT04616001
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
10 participants
INTERVENTIONAL
2020-11-01
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IVIG
IVIG 0.5gram/kg IVPB using actual body weight daily x 4 days
IVIG
Patients will receive IVIG daily for four days.
Interventions
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IVIG
Patients will receive IVIG daily for four days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Sharp HealthCare
OTHER
Responsible Party
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George Sakoulas, MD
Infectious Disease Specialist
Principal Investigators
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George Sakoulas, MD
Role: PRINCIPAL_INVESTIGATOR
Sharp HealthCare
Locations
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Sharp Memorial Hospital
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2010902
Identifier Type: OTHER
Identifier Source: secondary_id
COVID-IVIG VENT
Identifier Type: -
Identifier Source: org_study_id