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

June 23, 2021 updated by: George Sakoulas, MD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Mesa, California, United States, 91942
        • Sharp Grossmont Hospital
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • IVIG
No Intervention: Group B (SOC)
Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Sakoulas, MD

Collaborators

Octapharma

Investigators

  • Principal Investigator: George Sakoulas, MD, Sharp HealthCare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2020

Primary Completion (Actual)

June 23, 2020

Study Completion (Actual)

June 23, 2020

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Actual)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 23, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-IVIG
  • 2004902 (Other Identifier: Sharp HealthCare Institutional Review Board (SHC IRB))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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