Outpatient Treatment With Anti-Coronavirus Immunoglobulin

Paused · Phase 3 · Has a placebo group

Conditions studied: COVID, SARS-CoV2 Infection, Covid19

In brief

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.

Key facts

Study ID

NCT04910269

Run by

University of Minnesota

People needed

820

Starts

2021-08-06

Expected to finish

2026-08-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an immunosuppressed condition.
• Positive test for SARS-CoV-2 within ≤5 days (if >1 test, the first positive is within ≤5 days). Tests may include an institutional-based nucleic acid amplification test (NAAT), or any protocol-approved rapid test.
• Within ≤5 days from symptom onset, if symptomatic from current SARS-CoV-2 infection.
• Agrees to not participate in another clinical trial for the treatment or management of SARS-CoV-2 infection through Day 7, or until hospitalized or significant disease progression if prior to Day 7 (defined by ordinal category 4 or 5).
• Participant provides written informed consent prior to study procedures, and understands and agrees to adhere to planned study procedures through Day 28.
• Ongoing immunosuppressive condition or immunosuppressive treatment, includes:
• Steroids equivalent to prednisone > 10 mg/day for at least the last 28 days
• Rheumatologic or autoimmune disorder treated with a biologic or non-biologic immunosuppressive therapy
• Antirejection medicine after solid organ or stem cell transplantation
• Cancer treatment with systemic chemotherapy, biologic and/or cell-based therapy in the last 12 months
• Primary or acquired severe B- or T-lymphocyte immune dysfunction
• HIV infection
• Splenectomy or functional asplenia

You may not qualify if…

• Asymptomatic and had prior symptoms from the current infection that have now resolved (for >24 hours).
• Asymptomatic and has received a vaccination for COVID-19 (≥1 dose).
• Undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes).
• Evidence of pneumonia and/or hypoxia due to COVID-19 (NOTE: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level).
• Prior receipt of immunoglobulin product or passive immune therapy for SARS-CoV-2 in the past 90 days (i.e., convalescent plasma, SARS-CoV-2 monoclonal antibodies, or any IVIG).
• Any of the following thrombotic or procoagulant conditions or disorders:
• acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization.
• prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin III, protein C, or protein S.
• History of hypersensitivity to blood, plasma or IVIG excipients.
• Known immunoglobulin A (IgA) deficiency or anti-IgA antibodies.
• In the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.

Where it is running

• VA Northern California Health Care System (074-023) — Mather, California, United States
• Stanford University Hospital & Clinics (Site 203-003) — Palo Alto, California, United States
• San Francisco VAMC (Site 074-002) — San Francisco, California, United States
• Rocky Mountain Regional VA Medical Center (074-010) — Aurora, Colorado, United States
• Henry Ford Health System Site (014-001) — Detroit, Michigan, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Cleveland Clinic Foundation (Site 207-001) — Cleveland, Ohio, United States
• Penn State Health Milton S. Hershey Medical Center (209-002) — Hershey, Pennsylvania, United States
• CHRISTUS Spohn Shoreline Hospital — Corpus Christi, Texas, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Intermountain Medical Center (211-001) — Murray, Utah, United States
• UVA Health System, University Hospital (Site 210-003) — Charlottesville, Virginia, United States
• Carilion Medical Center (Site 080-018) — Roanoke, Virginia, United States
• Salem VA Medical Center (074-014) — Salem, Virginia, United States
• Swedish Hospital First Hill — Seattle, Washington, United States
• Instituto Medico Platense — La Plata, Buenos Aires, Argentina
• Centro de Investigaciones Medicas de Mar del Plata (Site 611-031) — Mar del Plata, Buenos Aires, Argentina
• Clínica Central S.A. (611-028) — Villa Regina, Río Negro Province, Argentina
• Hospital General de Agudos JM Ramos Mejia — Buenos Aires, Argentina
• St. Vincent's Hospital — Sydney, New South Wales, Australia
• Odense University Hospital — Odense, C, Denmark
• Aarhus Universitetshospital, Skejby — Aarhus, N, Denmark
• Department of Infectious Diseases — Aalborg, Denmark
• Rigshospitalet, CHIP — Copenhagen, Denmark
• Southern Arizona VA Healthcare System (074-009) — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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