Clinical trial NCT04411667: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sars-CoV2
Keywords: Coronavirus
IVIG
COVID-19
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: Octapharma
First posted: 2020-06-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mechanical Ventilation
timeFrame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Secondary outcomes:
measure: Oxygen Therapy
timeFrame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
measure: Length of Stay
timeFrame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 days
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: Sharp Grossmont Hospital
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
Study officials:
affiliation: Sharp HealthCare
name: George Sakoulas, MD
role: PRINCIPAL_INVESTIGATOR
References: