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

NCT04411667 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: COVID-IVIG2004902
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Sars-CoV2

Keywords

Coronavirus; IVIG; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Oxygen Therapy

  from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days

• 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

Study Arms (2)

Group A (study drug+SOC)

EXPERIMENTAL

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

Group B (SOC)

NO INTERVENTION

Standard of Care

Interventions

Octagam DRUG

Standard of Care plus Octagam infusion for 3 days.

Also known as: IVIG

Group A (study drug+SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• George Sakoulas, MD: lead
• Octapharma: collaborator

Study Sites (2)

Sharp Grossmont Hospital

La Mesa, California, 91942, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Octagam; Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

* Study limited to two hospitals in one US city. Resulted in a homogenous population of younger Hispanic/Latino patients. * Study was not blinded. * Methylprednisolone was used as a pre-medication for each dose of IVIG which may have confounded the results. * Small sample size.

Results Point of Contact

• Title: Matthew Geriak, PharmD / Research Pharmacist
• Organization: Sharp HealthCare

matthew.geriak@sharp.com

8589393717

Study Officials

• George Sakoulas, MD

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Infectious Disease Specialist

Model Details: Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 2, 2020
• Study Start: April 28, 2020
• Primary Completion: June 23, 2020
• Study Completion: June 23, 2020
• Last Updated: June 25, 2021
• Results First Posted: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)