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

NCT ID: NCT04411667

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-28
• Study Completion Date: 2020-06-23

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.

Conditions

Sars-CoV2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Octagam

Intervention Type: DRUG

Standard of Care plus Octagam infusion for 3 days.

Group B (SOC)

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Octagam

Standard of Care plus Octagam infusion for 3 days.

Intervention Type: DRUG

Other Intervention Names

IVIG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Octapharma

INDUSTRY

Sponsor Role: collaborator

George Sakoulas, MD

OTHER

Sponsor Role: lead

Responsible Party

George Sakoulas, MD

Infectious Disease Specialist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

George Sakoulas, MD

Role: PRINCIPAL_INVESTIGATOR

Sharp HealthCare

Locations

Sharp Grossmont Hospital

La Mesa, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2004902

Identifier Type: OTHER

Identifier Source: secondary_id

COVID-IVIG

Identifier Type: -

Identifier Source: org_study_id