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Immunoglobulin
hIVIG for COVID-19 (OTAC Trial)
Phase 3
Recruiting
Led By Cavan Reilly, PhD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an immunosuppressed condition.
Steroids equivalent to prednisone > 10 mg/day for at least the last 28 days
Must not have
Acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization
Asymptomatic and has received a vaccination for COVID-19 (≥1 dose)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7, 14, 28 days
Awards & highlights
Pivotal Trial
Summary
This trial is for people with recently diagnosed SARS-CoV-2 infection who do not require hospitalization. The goal is to compare the safety and efficacy of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) versus placebo.
Who is the study for?
Adults recently diagnosed with COVID-19, not hospitalized but at high risk due to age (≥55 years), immunosuppression, or certain medical treatments like chemotherapy. Participants must agree not to join other SARS-CoV-2 trials until Day 7 and should have started symptoms within the last 5 days.
What is being tested?
The trial is testing if a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) is safer and more effective than a placebo in adults with mild to moderate COVID-19. The study randomly assigns participants to receive either hIVIG or placebo and monitors their health status after seven days.
What are the potential side effects?
Potential side effects may include allergic reactions to the infusion, such as rash or difficulty breathing. Since it's an immunoglobulin product, there might also be risks related to blood products like clotting issues or transmission of infectious agents.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 55 years old or have a condition that weakens my immune system.
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I have been taking more than 10 mg/day of steroids like prednisone for the last 28 days.
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I am being treated for an autoimmune disorder with immunosuppressive therapy.
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I am taking medication to prevent organ rejection after a transplant.
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I am over 55 years old or have a condition that weakens my immune system.
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I am currently on immunosuppressive treatment or have a condition that weakens my immune system.
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I tested positive for COVID-19 within the last 5 days.
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My immune system has a severe dysfunction affecting B or T cells.
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I am HIV positive.
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I have had my spleen removed or it doesn't work properly.
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I haven't had chemotherapy or biological therapy for cancer in the past year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a heart attack, stroke, blood clot in my lungs or deep veins in the last 28 days.
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I have received at least one COVID-19 vaccine dose and feel fine.
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I have a specific blood clotting disorder.
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I have a condition that affects my blood's ability to clot.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7, 14, 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7, 14, 28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Status
Secondary study objectives
Activity Limitations at Follow-up
Therapeutic procedure
All-cause hospitalization or death through 28 days.
+12 moreSide effects data
From 2021 Phase 3 trial • 593 Patients • NCT045465813%
Dyspnoea
3%
Pyrexia
3%
Chills
2%
Respiratory Distress
1%
Respiratory Failure
1%
Hypoxia
1%
Cough
1%
Hypotension
1%
Anaemia
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intervention Group
Control Group
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment GroupExperimental Treatment1 Intervention
Participants in this group will receive the investigational treatment in addition to standard of care.
Group II: Placebo GroupPlacebo Group1 Intervention
Participants in this group will receive a placebo in addition to standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)
2020
Completed Phase 3
~600
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,621,138 Total Patients Enrolled
29 Trials studying COVID-19
25,883 Patients Enrolled for COVID-19
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,334 Previous Clinical Trials
5,376,424 Total Patients Enrolled
85 Trials studying COVID-19
342,151 Patients Enrolled for COVID-19
National Institutes of Health (NIH)NIH
2,837 Previous Clinical Trials
8,170,886 Total Patients Enrolled
36 Trials studying COVID-19
331,733 Patients Enrolled for COVID-19
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)NETWORK
14 Previous Clinical Trials
7,898 Total Patients Enrolled
12 Trials studying COVID-19
7,437 Patients Enrolled for COVID-19
Cavan Reilly, PhDPrincipal InvestigatorUniversity of Minnesota
3 Previous Clinical Trials
4,000 Total Patients Enrolled
2 Trials studying COVID-19
3,000 Patients Enrolled for COVID-19
James Neaton, PhDPrincipal InvestigatorUniversity of Minnesota
7 Previous Clinical Trials
23,673 Total Patients Enrolled
4 Trials studying COVID-19
15,566 Patients Enrolled for COVID-19