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

• ClinicalTrials.gov Identifier: NCT04411667
• Recruitment Status: Completed
• First Posted: June 2, 2020
• Results First Posted: June 25, 2021
• Last Update Posted: June 25, 2021
• Sponsor: George Sakoulas, MD
• Collaborator: Octapharma
• Information provided by (Responsible Party): George Sakoulas, MD, Sharp HealthCare

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sars-CoV2	Drug: Octagam	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 28, 2020
• Actual Primary Completion Date: June 23, 2020
• Actual Study Completion Date: June 23, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Octagam; Standard of Care plus Octagam infusion for 3 days.; Other Name: IVIG
No Intervention: Group B (SOC); Standard of Care

Outcome Measures

Primary Outcome Measures :

1. Mechanical Ventilation [ Time Frame: 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 :

1. Oxygen Therapy [ Time Frame: 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
2. Length of Stay [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Sharp Grossmont Hospital

La Mesa, California, United States, 91942

Sharp Memorial Hospital

San Diego, California, United States, 92123

Sponsors and Collaborators

George Sakoulas, MD

Octapharma

Investigators

• Principal Investigator: George Sakoulas, MD; Sharp HealthCare

  Study Documents (Full-Text)

Documents provided by George Sakoulas, MD, Sharp HealthCare:

Study Protocol and Statistical Analysis Plan  [PDF] May 19, 2020

More Information

• Responsible Party: George Sakoulas, MD, Infectious Disease Specialist, Sharp HealthCare
• ClinicalTrials.gov Identifier: NCT04411667
• Other Study ID Numbers: COVID-IVIG; 2004902 ( Other Identifier: Sharp HealthCare Institutional Review Board (SHC IRB) )
• First Posted: June 2, 2020
• Results First Posted: June 25, 2021
• Last Update Posted: June 25, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by George Sakoulas, MD, Sharp HealthCare:

Coronavirus; IVIG; COVID-19

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunologic Factors; Physiological Effects of Drugs