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Outpatient Treatment With Anti-Coronavirus Immunoglobulin

NCT04910269 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 820

Last updated 2026-04-20

No results posted yet for this study

Summary

The primary objective of the Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC) (INSIGHT 012) trial is to compare the safety and efficacy of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) versus placebo among adults with recently diagnosed severe acute respiratory syndrome - coronavirus 2 (SARS-CoV2) infection who do not require hospitalization. The primary endpoint of this double-blind randomized trial is a five-category ordinal outcome that assesses the participant's clinical status seven days after the infusion of hIVIG or placebo.

1. Asymptomatic and no limitations in usual activity due to COVID-19
2. Mild COVID-19 illness or minor limitations to usual activity
3. Moderate COVID-19 illness and with major limitations to usual activity
4. Severe COVID-19 or serious disease manifestation from COVID-19
5. Critical illness from COVID-19 or Death

Two strata of participants will be identified for analysis purposes. Stratum 2 will be participants who receive direct-acting antivirals (DAAs) or other anti-SARS-CoV2 agents that are approved/available and recommended for use as part of standard of care (SOC), estimated to be about 20% of participants. Stratum 1 will be participants who do not receive this agents, estimated to be about 80% of participants.

Conditions

  • COVID
  • SARS-CoV2 Infection
  • Covid19

Interventions

BIOLOGICAL

Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)

The hIVIG product is administered as a single dose of 3.5 grams, or 35 milliliter at a concentration of 0.1 grams/milliliter.

OTHER

Placebo

Infusion of 35 milliliters standard isotonic saline

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

  • Cavan Reilly, PhD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2026-08-01
Completion
2026-08-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Denmark
  • Greece
  • India
  • Malaysia
  • Mexico
  • Peru
  • Spain
  • Thailand
  • Uganda
  • Ukraine
  • 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 NCT04910269 on ClinicalTrials.gov