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Outpatient treatment with anti-coronavirus immunoglobulin

An International Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19

Phase 3 Interventional University of Minnesota · NCT04910269

This study is testing if a special treatment for COVID-19 can help adults who have just been diagnosed and don’t need to go to the hospital feel better compared to those who get a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment820 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Minnesota Academic / other
Drugs / interventionschemotherapy, prednisone
Locations66 sites (Tucson, Arizona and 65 other locations)
Trial IDNCT04910269 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the safety and efficacy of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) compared to a placebo in adults recently diagnosed with SARS-CoV-2 infection who do not require hospitalization. Participants will be randomized to receive either hIVIG or placebo alongside standard care, with their clinical status assessed seven days post-infusion. The study will analyze two groups to determine the treatment's effectiveness in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have tested positive for SARS-CoV-2 within the last five days and are either symptomatic or at high risk due to age or immunosuppressed conditions.

Not a fit: Patients who are already hospitalized or have critical illness from COVID-19 may not benefit from this outpatient treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new outpatient option for managing COVID-19, potentially reducing the severity of illness and the need for hospitalization.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches for COVID-19, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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:

1. Steroids equivalent to prednisone \> 10 mg/day for at least the last 28 days
2. Rheumatologic or autoimmune disorder treated with a biologic or non-biologic immunosuppressive therapy
3. Antirejection medicine after solid organ or stem cell transplantation
4. Cancer treatment with systemic chemotherapy, biologic and/or cell-based therapy in the last 12 months
5. Primary or acquired severe B- or T-lymphocyte immune dysfunction
6. HIV infection
7. Splenectomy or functional asplenia

Exclusion Criteria:

* 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:

  1. acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization.
  2. 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 this trial is running

Tucson, Arizona and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions COVIDSARS-CoV2 InfectionCovid19immunotherapyhIVIGearly treatment
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.