Status:
RECRUITING
Outpatient Treatment With Anti-Coronavirus Immunoglobulin
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Conditions:
COVID
SARS-CoV2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 hyperimmun...
Detailed Description
The primary objective will be addressed by testing two hypotheses aimed at assessing whether hIVIG + standard of care (SOC) is superior to placebo + SOC for the primary ordinal endpoint at Day 7. Thes...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT04910269
Start Date
August 6 2021
End Date
August 1 2026
Last Update
December 17 2025
Active Locations (65)
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1
Southern Arizona VA Healthcare System (074-009)
Tucson, Arizona, United States, 85723
2
VA Northern California Health Care System (074-023)
Mather, California, United States, 95655
3
Stanford University Hospital & Clinics (Site 203-003)
Palo Alto, California, United States, 94305
4
San Francisco VAMC (Site 074-002)
San Francisco, California, United States, 94121