IVIG in Patients With Severe COVID-19 Requiring Mechanical Ventilation
Purpose
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.
Conditions
- Covid19
- SARS-CoV Infection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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).
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Open label, single group, pilot study
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IVIG |
IVIG 0.5gram/kg IVPB using actual body weight daily x 4 days |
|
Recruiting Locations
More Details
- NCT ID
- NCT04616001
- Status
- Unknown status
- Sponsor
- Sharp HealthCare
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.