← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7, 14, 28 days
Awards & highlights

OTAC 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.Check my eligibility
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.See study design
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.

OTAC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 55 years old or have a condition that weakens my immune system.
Select...
I have been taking more than 10 mg/day of steroids like prednisone for the last 28 days.
Select...
I am being treated for an autoimmune disorder with immunosuppressive therapy.
Select...
I am taking medication to prevent organ rejection after a transplant.
Select...
I am over 55 years old or have a condition that weakens my immune system.
Select...
I am currently on immunosuppressive treatment or have a condition that weakens my immune system.
Select...
I tested positive for COVID-19 within the last 5 days.
Select...
My immune system has a severe dysfunction affecting B or T cells.
Select...
I am HIV positive.
Select...
I have had my spleen removed or it doesn't work properly.
Select...
I haven't had chemotherapy or biological therapy for cancer in the past year.

OTAC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7, 14, 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7, 14, 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Status
Secondary outcome measures
Activity Limitations at Follow-up
Therapeutic procedure
All-cause hospitalization or death through 28 days.
+12 more

Side effects data

From 2021 Phase 3 trial • 593 Patients • NCT04546581
3%
Dyspnoea
3%
Pyrexia
3%
Chills
2%
Respiratory Distress
1%
Hypoxia
1%
Respiratory Failure
1%
Cough
1%
Hypotension
1%
Anaemia
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intervention Group
Control Group

OTAC 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
1,381 Previous Clinical Trials
1,587,955 Total Patients Enrolled
27 Trials studying COVID-19
26,149 Patients Enrolled for COVID-19
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,484,417 Total Patients Enrolled
78 Trials studying COVID-19
291,388 Patients Enrolled for COVID-19
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,056 Total Patients Enrolled
34 Trials studying COVID-19
331,494 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If a patient meets the requirements, can they enroll in this clinical trial?

"The trial, as noted on the website clinicaltrials.gov, is still looking for participants. The listing went up on 8/6/2021 and was updated on 3/25/2022."

Answered by AI

Could you please tell us about the risks associated with hIVIG therapy?

"There is already some clinical data supporting the efficacy of hIVIG as well as its safety, so it received a score of 3."

Answered by AI

How many people are included in this trial at most?

"That is correct, the online information indicates that the research team is still looking for patients. The clinical trial was originally advertised on August 6th 2021 with a most recent update on March 25th 2022. A total of 820 individuals are needed to enroll at 10 different locations."

Answered by AI

What other research has been conducted on hIVIG's potential to fight SARS-CoV-2?

"Currently, there is 1 clinical trial in operation researching Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG). That active study is in Phase 3. 38 locations are running studies for this treatment; however, the majority of those studies are based in Jodhpur, Rajasthan."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
New York
How old are they?
18 - 65
What site did they apply to?
MedStar Health Research Institute
Washington DC Veterans Affairs Medical Center
Mount Sinai Beth Israel Hospital
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Outpatient Treatment With Anti-Coronavirus Immunoglobulin
2021. "Outpatient Treatment With Anti-Coronavirus Immunoglobulin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04910269.
All > Coronavirus > Immunotherapy
~70 spots leftby Aug 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top