NCT04616001

Brief Summary

The purpose of this Pilot Study is to establish a hypothesis of whether or not intravenous immunoglobulin (IVIG) may impact the hospital length of stay, if started within 48 of mechanical ventilation in patients infected with SARS-CoV-2 virus.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_4 covid19

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

November 2, 2020

Last Update Submit

November 2, 2020

Conditions

Covid19SARS-CoV Infection

Outcome Measures

Primary Outcomes (1)

  • Hospital length of stay

    Assess hospital length of stay after mechanical ventilation

    Up to 60 days

Secondary Outcomes (1)

  • Human metabolome and proteome

    Up to 60 days

Study Arms (1)

IVIG

EXPERIMENTAL

IVIG 0.5gram/kg IVPB using actual body weight daily x 4 days

Drug: IVIG

Interventions

IVIGDRUG

Patients will receive IVIG daily for four days.

Also known as: Octagam
IVIG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed COVID-19 positive test result
  • Initiation of the first dose of IVIG within 72 hours of mechanical ventilation.
  • Age \>18 years old.
  • Consenting next of kin having access to an electronic device that is able to access DocuSign® online and email for consenting.
  • Subjects or their proxy must have the ability to understand the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.

You may not qualify if:

  • Superimposed bacterial pneumonia or bacteremia
  • Severe allergy to any IVIG product formulation
  • Hypersensitivity to corn
  • Uncontrolled hypertension (SBP\>180 mm Hg or DBP\>120mmHg)
  • Active participant in another research treatment study
  • Advanced dementia
  • Severe renal disease (CrCl\< 20 mL/min)
  • Active cancer malignancy
  • Active treatment with cancer chemotherapy or immunotherapy
  • Congestive heart failure clinically or by history (EF\< 25%)
  • Prior receipt during admission of any other investigational agent (eg. convalescent plasma, tocilizumab)
  • Venous or arterial thrombosis \< 90 days prior
  • Are receiving cytotoxic or biologic treatments such as TNF inhibitors, anti-interleukin-1 (IL-1), anti-IL-6 (tocilizumab or sarilumab), T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry. Note: A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening, with the following exceptions:
  • B-cell targeted therapies: a washout period of 24 weeks or 5 half-lives (whichever is longer)
  • TNF inhibitors: a washout period of 2 weeks or 5 half-lives (whichever is longer), and
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory Syndrome

Interventions

Immunoglobulins, IntravenousOctagam

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • George Sakoulas, MD

    Sharp HealthCare

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Miller

CONTACT

858-939-7161kathryn.miller@sharp.com

Matthew Geriak, PharmD

CONTACT

858-939-3717matthew.geriak@sharp.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label, single group, pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Infectious Disease Specialist

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 4, 2020

Study Start

November 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)