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

Primary Purpose

Sars-CoV2

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Octagam
Sponsored by
George Sakoulas, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sars-CoV2 focused on measuring Coronavirus, IVIG, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sharp Grossmont Hospital
  • Sharp Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A (study drug+SOC)

Group B (SOC)

Arm Description

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.

Standard of Care

Outcomes

Primary Outcome Measures

Mechanical Ventilation
Number of subjects requiring mechanical ventilation due to respiratory failure

Secondary Outcome Measures

Oxygen Therapy
Number of days requiring oxygen therapy
Length of Stay
Number of days in hospital

Full Information

First Posted
May 29, 2020
Last Updated
June 23, 2021
Sponsor
George Sakoulas, MD
Collaborators
Octapharma
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1. Study Identification

Unique Protocol Identification Number
NCT04411667
Brief Title
Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 28, 2020 (Actual)
Primary Completion Date
June 23, 2020 (Actual)
Study Completion Date
June 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
George Sakoulas, MD
Collaborators
Octapharma

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sars-CoV2
Keywords
Coronavirus, IVIG, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (study drug+SOC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B (SOC)
Arm Type
No Intervention
Arm Description
Standard of Care
Intervention Type
Drug
Intervention Name(s)
Octagam
Other Intervention Name(s)
IVIG
Intervention Description
Standard of Care plus Octagam infusion for 3 days.
Primary Outcome Measure Information:
Title
Mechanical Ventilation
Description
Number of subjects requiring mechanical ventilation due to respiratory failure
Time Frame
from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Secondary Outcome Measure Information:
Title
Oxygen Therapy
Description
Number of days requiring 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
Title
Length of Stay
Description
Number of days in hospital
Time Frame
from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Sakoulas, MD
Organizational Affiliation
Sharp HealthCare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharp Grossmont Hospital
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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