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

Sars-CoV2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411667
• Other study ID #: COVID-IVIG
• Secondary ID: 2004902
• Status: Completed
• Phase: Phase 4
• Start date: April 28, 2020
• Est. completion date: June 23, 2020

Study information

• Verified date: June 2021
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 23, 2020
• Est. primary completion date: June 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

• 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

Related Conditions & MeSH terms

• Sars-CoV2

Intervention

Drug:
• Octagam
Standard of Care plus Octagam infusion for 3 days.

Locations

Country	Name	City	State
United States	Sharp Grossmont Hospital	La Mesa	California
United States	Sharp Memorial Hospital	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
George Sakoulas, MD	Octapharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical Ventilation	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	Oxygen Therapy	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
Secondary	Length of Stay	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