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Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)

NCT04546581 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 593

Last updated 2022-04-04

Study results available
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Summary

This protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for an individual patient.

Conditions

Interventions

BIOLOGICAL

Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)

Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.

OTHER

Placebo

Participants will receive a single infusion of the placebo (saline).

DRUG

Remdesivir

Remdesivir will be given to participants in both groups as standard of care (SOC).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

    collaborator NETWORK

  • University of Minnesota

    lead OTHER

Principal Investigators

  • James Neaton, PhD · University of Minnesota

  • Mark Polizzotto, MD · Kirby Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2021-05-21
Completion
2021-05-21
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Greece
  • Japan
  • Nigeria
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04546581 on ClinicalTrials.gov