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Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19

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ClinicalTrials.gov Identifier: NCT04411667
Recruitment Status : Active, not recruiting
First Posted : June 2, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Octapharma
Information provided by (Responsible Party):
George Sakoulas, MD, Sharp HealthCare

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sars-CoV2 Drug: Octagam Phase 4

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Open Label Study of Standard of Care Plus Intravenous Immunoglobulin (IVIG) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 30, 2020

Arm Intervention/treatment
Experimental: 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.
Drug: Octagam
Standard of Care plus Octagam infusion for 3 days.
Other Name: IVIG

No Intervention: Group B (SOC)
Standard of Care



Primary Outcome Measures :
  1. Mechanical Ventilation [ Time Frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days ]
    Number of subjects requiring mechanical ventilation due to respiratory failure


Secondary Outcome Measures :
  1. Oxygen Therapy [ Time Frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days ]
    Number of days requiring oxygen therapy

  2. Length of Stay [ Time Frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days ]
    Number of days in hospital



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed COVID-19 positive test result (including presumptive positive).
  • Hospitalization
  • Requiring ≥4 liters/min O2 nasal cannula to maintain oxygen saturation ≥ 92%, but not mechanically ventilated
  • Age ≥18 years old.
  • Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail.
  • Able to read/write/speak English or Spanish fluently.
  • Subjects must have the capacity to provide consent or an appropriate Legally Authorized Representative (LAR) to provide informed consent.

provide informed consent, and provide authorization of use and disclosure of personal health information.

  • Negative pregnancy test for women of childbearing potential.

Exclusion Criteria:

  • Severe allergy to any IVIG product formulation
  • History of DVT, PE, thromboembolic stroke or other thrombotic events
  • Hypersensitivity to corn. Octagam® contains maltose which is a sugar derived from corn.
  • Uncontrolled hypertension (SBP>180 mm Hg or DBP>120mmHg)
  • Active participant in another research treatment study
  • Mechanically ventilated patient
  • Code status is Do Not Resuscitate or Do Not Intubate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04411667


Locations
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United States, California
Sharp Grossmont Hospital
La Mesa, California, United States, 91942
Sharp Memorial Hospital
San Diego, California, United States, 92123
Sponsors and Collaborators
George Sakoulas, MD
Octapharma
Investigators
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Principal Investigator: George Sakoulas, MD Sharp HealthCare
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Responsible Party: George Sakoulas, MD, Infectious Disease Specialist, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT04411667    
Other Study ID Numbers: COVID-IVIG
2004902 ( Other Identifier: Sharp HealthCare Institutional Review Board (SHC IRB) )
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by George Sakoulas, MD, Sharp HealthCare:
Coronavirus
IVIG
COVID-19
Additional relevant MeSH terms:
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gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs