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

Phase 4

Completed

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.

Recruitment & Eligibility

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.

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

Arm && Interventions

Group	Intervention	Description
Group A (study drug+SOC)	Octagam	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.

Primary Outcome Measures

Name	Time	Method
Mechanical Ventilation	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

Name	Time	Method
Length of Stay	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
Oxygen Therapy	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