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

George Sakoulas, MD

Status and phase: Completed; Phase 4

Conditions: Sars-CoV2

Treatments: Drug: Octagam

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04411667

COVID-IVIG

2004902 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Group A (study drug+SOC)

Experimental group

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.

Treatment:

Drug: Octagam

Group B (SOC)

No Intervention group

Description:

Standard of Care