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NCT04910269RECRUITINGIRB Ready

Outpatient Treatment With Anti-Coronavirus Immunoglobulin

(OTAC)

Sponsored by University of Minnesota

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 820 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Clinical risk based on age โ‰ฅ 55 years or an adult (age โ‰ฅ 18 years) with an immunosuppressed condition.
Positive test for SARS-CoV-2 within โ‰ค5 days (if \>1 test, the first positive is within โ‰ค5 days). Tests may include an institutional-based nucleic acid amplification test (NAAT), or any protocol-approved rapid test.
Within โ‰ค5 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: 1. Steroids equivalent to prednisone \> 10 mg/day for at least the last 28 days 2. Rheumatologic

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

820 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

University of Minnesota

Study Locations

Choose your preferred location or select flexible during enrollment

TERMINATED

Tucson

Arizona

Location available
View Tucson location page
TERMINATED

Mather

California

Location available
View Mather location page
RECRUITING

Palo Alto

California

Location available
View Palo Alto location page
TERMINATED

San Francisco

California

Location available
View San Francisco location page
TERMINATED

Aurora

Colorado

Location available
View Aurora location page
WITHDRAWN

Washington D.C.

District of Columbia

Location available
View Washington D.C. location page
WITHDRAWN

Washington D.C.

District of Columbia

Location available
View Washington D.C. location page
WITHDRAWN

Baltimore

Maryland

Location available
View Baltimore location page
RECRUITING

Detroit

Michigan

Location available
View Detroit location page

๐Ÿ“ And 13 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for COVID-19 Treatment in Tucson?

Join others in Arizona exploring innovative treatment options through clinical research

COVID-19 Treatment Options in Tucson, Arizona

If you're searching for COVID-19 treatment in Tucson, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Tucson, Mather, Palo Alto and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with COVID-19. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 820 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for COVID-19?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for COVID-19

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This COVID-19 Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04910269. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.