COVIDPhase 3OTACNCT04910269
Outpatient Treatment With Anti-Coronavirus Immunoglobulin
A Phase 3 study testing Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) in people with COVID and SARS-CoV2 Infection, run by University of Minnesota at 57 sites in 13 countries.
Trial 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 hyperimmune intravenous immunoglobulin (hIVIG) versus placebo among adults with recently diagnosed severe acute respiratory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, SARS-CoV2 Infection, Covid19
- What is being tested?
- Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 741 participants
- Where
- 57 sitesin 13 countries
- Study dates
- 6 Aug 2021to 14 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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:
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- 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.
Trial locations and contacts
57 sites in 13 countries.
57 sites in 13 countries
United States16 sites
Rocky Mountain Regional VA Medical Center (074-010)
Aurora, Colorado, 80045
UVA Health System, University Hospital (Site 210-003)
Charlottesville, Virginia, 22908
Cleveland Clinic Foundation (Site 207-001)
Cleveland, Ohio, 44195
CHRISTUS Spohn Shoreline Hospital
Corpus Christi, Texas, 78404
UT Southwestern Medical Center
Dallas, Texas, 75390
Henry Ford Health System Site (014-001)
Detroit, Michigan, 48202
Penn State Health Milton S. Hershey Medical Center (209-002)
Hershey, Pennsylvania, 17033
VA Northern California Health Care System (074-023)
Mather, California, 95655
Intermountain Medical Center (211-001)
Murray, Utah, 84107
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Stanford University Hospital & Clinics (Site 203-003)
Palo Alto, California, 94305
Carilion Medical Center (Site 080-018)
Roanoke, Virginia, 24015
Salem VA Medical Center (074-014)
Salem, Virginia, 24153
San Francisco VAMC (Site 074-002)
San Francisco, California, 94121
Swedish Hospital First Hill
Seattle, Washington, 98122
Southern Arizona VA Healthcare System (074-009)
Tucson, Arizona, 85723
Denmark8 sites
Department of Infectious Diseases
Aalborg, 9000
Aarhus Universitetshospital, Skejby
Aarhus, N, 8200
Rigshospitalet, CHIP
Copenhagen, 2100
Bispebjerg Hospital
Copenhagen, 2400
Herlev/Gentofte Hospital
Hellerup, 2900
Hvidovre University Hospital, Department of Infectious Diseases
Hvidovre, 2650
Kolding Sygehus
Kolding, 6000
Odense University Hospital
Odense, C, 5000
Uganda6 sites
MRC/UVRI & LSHTM Uganda Research Unit
Entebbe
Joint Clinical Research Center (JCRC)
Kampala
Makerere University Lung Institute (Site 634-604)
Kampala
St. Francis Hospital, Nsambya
Kampala
Lira Regional Referral Hospital
Lira
Masaka Regional Referral Hospital
Masaka
Greece5 sites
Dept of Critical Care and Pulmonary Medicine, Evangelismos General Hospital
Athens, Attica, 10676
3rd Dept of Medicine, Medical School
Athens, Attica, 11527
Laiko Athens General Hospital
Athens, Attica, 11527
Department of Clinical Therapeutics of Alexandra Hospital
Athens, Attica, 11528
4th Department of Internal Medicine
Athens, Attica, 12462
Argentina4 sites
Hospital General de Agudos JM Ramos Mejia
Buenos Aires, C1221ADC
Instituto Medico Platense
La Plata, Buenos Aires, B1900AVG
Centro de Investigaciones Medicas de Mar del Plata (Site 611-031)
Mar del Plata, Buenos Aires, B7600FYK
Clínica Central S.A. (611-028)
Villa Regina, Río Negro Province, R8336
Mexico4 sites
Hospital General Dr. Manuel Gea Gonzáles
Mexico City, Mexico City, 14080
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14080
Instituto Nacional de Enfermedades Respiratorias Ismael Cosió Villegas
Mexico City, Mexico City, 14080
Hospital General Dr. Aurelio Valdivieso
Oaxaca City, OA, 68050
Spain4 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
CAP Corbera
Barcelona, 08757
CAP Can Bou
Castelldefels, Barcelona, 08860
CAP El Maresme
Mataró, Barcelona, 08303
Thailand4 sites
Siriraj Hospital (Site 613-002)
Bangkok Noi, Bangkok, 10700
Khon Kaen University, Srinagarind Hospital (Site 613-003)
Khon Kaen, 40002
Bamrasnaradura Infections Diseases Institute (613-007)
Nonthaburi, 11000
Chulalongkorn University and The HIV-NAT
Pathum Wan, Bangkok, 10330
United Kingdom2 sites
University College London Hospitals
London, WC1E 6JB
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Malaysia1 site
University Malaya Medical Centre (Site 612-501)
Kuala Lumpur, Kuala Lumpur, 59100
Peru1 site
Unidad de Ensayos Clinicos Socios En Salud Sucursal Perú (651-009)
Lima, 15012
Ukraine1 site
Central City Clinical Hospital of Ivano-Frankivsk City Council
Ivano-Frankivsk, 76018
About this study
Official title: 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
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. The primary endpoint of this double-blind randomized trial is a five-category ordinal outcome that assesses the participant's clinical status seven days after the infusion of hIVIG or placebo.
- Asymptomatic and no limitations in usual activity due to COVID-19
- Mild COVID-19 illness or minor limitations to usual activity
- Moderate COVID-19 illness and with major limitations to usual activity
- Severe COVID-19 or serious disease manifestation from COVID-19
- Critical illness from COVID-19 or Death
Two strata of participants will be identified for analysis purposes. Stratum 2 will be participants who receive direct-acting antivirals (DAAs) or other anti-SARS-CoV2 agents that are approved/available and recommended for use as part of standard of care (SOC), estimated to be about 20% of participants. Stratum 1 will be participants who do not receive this agents, estimated to be about 80% of participants.
Read the 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. These hypotheses will be tested for the following two groups: a) among all randomized participants (stratum 1 and 2), and b) among only participants enrolled in stratum 1. For the primary analysis, overall type 1 error will be controlled at 5% by using a 2-sided significance level of 0.035 for each hypothesis. This significance level was obtained using the correlation between the test statistics for the proportional log odds ratio for all randomized participants and for this log odds ratio for those in stratum 1. This correlation was determined to be 0.895. With this approach hIVIG will be considered superior to placebo if either of the two hypotheses is rejected.
Participants will be randomized to a single infusion of an hIVIG product or placebo in a 1:1 allocation. Randomization will be stratified by study site pharmacy and the two SOC strata.
- Conditions
- COVID, SARS-CoV2 Infection, Covid19
- Being tested
- Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG), Placebo
- Keywords
- immunotherapy, hIVIG, early treatment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)Biological
The hIVIG product is administered as a single dose of 3.5 grams, or 35 milliliter at a concentration of 0.1 grams/milliliter.
PlaceboOther
Infusion of 35 milliliters standard isotonic saline
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants in this group will receive the investigational treatment in addition to standard of care. Receives: Biological: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) |
| Placebo Group | Placebo comparator | Participants in this group will receive a placebo in addition to standard of care. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Status
The primary outcome is to compare the safety and efficacy of a single infusion of hIVIG versus placebo on clinical status after seven days. Outcome will be reported as the percent of participants who fall into each of 5 clinical status categories as defined below.
- Asymptomatic and no limitations in usual activity due to COVID-19
- Mild COVID-19 illness or minor limitations to usual activity
- Moderate COVID-19 illness and with major limitations to usual activity
- Severe COVID-19 or serious disease manifestation from COVID-19
- Critical illness from COVID-19 or Death
Measured: 7 days
Secondary outcomes (15)
All-cause hospitalization or death through 28 days.
Outcome reported as the percent of participants who are hospitalized or who expire for any reason by day 28 post treatment.
Measured: 28 days
All-cause mortality through 28 days.
Outcome reported as the percent of participants who expire for any reason by day 28 post treatment.
Measured: 28 days
Significant Disease Progression
Outcome is reported as the number of participants with significant disease progression through 28 days, which is defined by fulfilling criteria for category 4 or 5 on the ordinal scale using a time to event analysis.
Measured: 28 days
Ordinal Scale Distribution
Outcome will be reported as the percent of participants who fall into each of 5 clinical status categories as defined below at days 4, 14, and 28 following treatment.
- Asymptomatic and no limitations in usual activity due to COVID-19
- Mild COVID-19 illness or minor limitations to usual activity
- Moderate COVID-19 illness and with major limitations to usual activity
- Severe COVID-19 or serious disease manifestation from COVID-19
- Critical illness from COVID-19 or Death
Measured: 4, 14, 28 days
Disease Progression Through 7 Days
Outcome is reported as the proportion of participants with any disease progression at Day 7, using a sliding dichotomous scale progression defined by a categorization on the ordinal scale that is worse than the status at entry.
Measured: 7 days
Significant Disease Progression Through 7 Days
Outcome is reported as the proportion of participants who progress to categories 3-5 on the clinical ordinal scale at Day 7 among participants in categories 1 or 2 of the ordinal scale at entry.
Measured: 7 days
Disease Progression at Follow-up
Outcome is reported as the percent of participants who experience severe disease progression during follow-up, defined by the worst health status achieved on the clinical ordinal scale at any point by Day 7, 14, and 28.
Measured: 7, 14, 28 days
Activity Limitations at Follow-up
Outcome is reported as the percent of participants who attain their pre-COVID health status without limitations in usual activity (defined as category 1 on the ordinal scale) at Day 7, 14, and 28.
Measured: 7, 14, 28 days
Change in Viral Burden from Serum Antigen
Outcome is reported as the change between Day 0 and Day 7 in viral burden as determined by serum antigen levels from nasal and saliva specimens.
Measured: 7 days
Change in Viral Burden from PCR
Outcome is reported as the change between Day 0 and Day 7 in viral burden as determined by polymerase chain reaction (PCR) from nasal and saliva specimens.
Measured: 7 days
Change in SARS-CoV-2 Antibody Concentration
Outcome is reported as the change in SARS-CoV-2 antibody levels between Day 0 and Day 7, including subclasses and neutralizing titers.
Measured: 7 days
Healthcare Utilization at Follow-up
Outcome is reported as the percent of participants who had health care engagement for the purposes of medical evaluation and/or management of COVID-19 illness (e.g., via telehealth, clinic, urgent care, emergency room, or hospitalization) at 28 days follow-up.
Measured: 28 days
Worst Status Through 28 Days
Outcome is reported as the number of participants who experience each of the following categories as their worst respiratory status through 28 days, including: a) no respiratory symptoms, b) upper respiratory symptoms, c) lower respiratory symptoms without hypoxia, c) hypoxia requiring conventional oxygen supplementation by nasal canula, d) respiratory failure requiring high-flow oxygen delivery device or non-invasive ventilation, or e) respiratory failure requiring mechanical ventilation or extra-corporeal membrane oxygenation (ECMO).
Measured: 28 days
Hypoxemia Through Day 7
Outcome is reported as the mean oxygen saturation (percentage) level in each group at 7 days.
Measured: 7 days
Additional COVID-19 Treatment
Outcome is reported as the number of patients starting other treatments targeting COVID-19 through 28 days post treatment.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start6 Aug 2021
- Primary completion24 May 2026
- Study completion14 Jun 2026
Why it stopped: Stopped for futility - no safety issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 741 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
- Responsible party
- Sponsor
- Investigators
- Cavan Reilly, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910269
- Sponsor's protocol ID
- INSIGHT12
- Other IDs
- 2021-001663-24
- Acronym
- OTAC
- Status last verified
- Aug 2026
- First submitted
- 1 Jun 2021
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A public data set will be made available at the end of the trial.
Publications
Jha A, Barker D, Lew J, Manoharan V, van Kessel J, Haupt R, Toth D, Frieman M, Falzarano D, Kodihalli S. Efficacy of COVID-HIGIV in animal models of SARS-CoV-2 infection. Sci Rep. 2022 Oct 10;12(1):16956. doi: 10.1038/s41598-022-21223-2.
PubMed 36216961
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04910269
- Acronym / sponsor ID
- OTAC / INSIGHT12
- Conditions
- COVID, SARS-CoV2 Infection, Covid19
- Keywords
- immunotherapy, hIVIG, early treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped for futility - no safety issues.
- Enrolment
- 741 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 24 May 2026 (actual)
- Study completion
- 14 Jun 2026 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The primary endpoint of this double-blind randomized trial is a five-category ordinal outcome that assesses the participant's clinical status seven days after the infusion of hIVIG or placebo.
- Asymptomatic and no limitations in usual activity due to COVID-19
- Mild COVID-19 illness or minor limitations to usual activity
- Moderate COVID-19 illness and with major limitations to usual activity
- Severe COVID-19 or serious disease manifestation from COVID-19
- Critical illness from COVID-19 or Death
Two strata of participants will be identified for analysis purposes. Stratum 2 will be participants who receive direct-acting antivirals (DAAs) or other anti-SARS-CoV2 agents that are approved/available and recommended for use as part of standard of care (SOC), estimated to be about 20% of participants. Stratum 1 will be participants who do not receive this agents, estimated to be about 80% of participants.
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. These hypotheses will be tested for the following two groups: a) among all randomized participants (stratum 1 and 2), and b) among only participants enrolled in stratum 1. For the primary analysis, overall type 1 error will be controlled at 5% by using a 2-sided significance level of 0.035 for each hypothesis. This significance level was obtained using the correlation between the test statistics for the proportional log odds ratio for all randomized participants and for this log odds ratio for those in stratum 1. This correlation was determined to be 0.895. With this approach hIVIG will be considered superior to placebo if either of the two hypotheses is rejected.
Participants will be randomized to a single infusion of an hIVIG product or placebo in a 1:1 allocation. Randomization will be stratified by study site pharmacy and the two SOC strata.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)Participants in this group will receive the investigational treatment in addition to standard of care. |
| Placebo Group | Placebo comparator | Other: PlaceboParticipants in this group will receive a placebo in addition to standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)The hIVIG product is administered as a single dose of 3.5 grams, or 35 milliliter at a concentration of 0.1 grams/milliliter. | Biological | Treatment Group |
| PlaceboInfusion of 35 milliliters standard isotonic saline | Other | Placebo Group |
Primary outcome
Clinical Status
Time frame: 7 days
The primary outcome is to compare the safety and efficacy of a single infusion of hIVIG versus placebo on clinical status after seven days. Outcome will be reported as the percent of participants who fall into each of 5 clinical status categories as defined below. 1. Asymptomatic and no limitations in usual activity due to COVID-19 2. Mild COVID-19 illness or minor limitations to usual activity 3. Moderate COVID-19 illness and with major limitations to usual activity 4. Severe COVID-19 or serious disease manifestation from COVID-19 5. Critical illness from COVID-19 or Death
15 secondary outcomes
All-cause hospitalization or death through 28 days.
Time frame: 28 days
All-cause mortality through 28 days.
Time frame: 28 days
Significant Disease Progression
Time frame: 28 days
Ordinal Scale Distribution
Time frame: 4, 14, 28 days
Disease Progression Through 7 Days
Time frame: 7 days
Significant Disease Progression Through 7 Days
Time frame: 7 days
Disease Progression at Follow-up
Time frame: 7, 14, 28 days
Activity Limitations at Follow-up
Time frame: 7, 14, 28 days
Change in Viral Burden from Serum Antigen
Time frame: 7 days
Change in Viral Burden from PCR
Time frame: 7 days
Change in SARS-CoV-2 Antibody Concentration
Time frame: 7 days
Healthcare Utilization at Follow-up
Time frame: 28 days
Worst Status Through 28 Days
Time frame: 28 days
Hypoxemia Through Day 7
Time frame: 7 days
Additional COVID-19 Treatment
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Stopped for futility - no safety issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Derived from this study: PubMed 36216961Jha A, Barker D, Lew J, Manoharan V, van Kessel J, Haupt R, Toth D, Frieman M, Falzarano D, Kodihalli S. Efficacy of COVID-HIGIV in animal models of SARS-CoV-2 infection. Sci Rep. 2022 Oct 10;12(1):16956. doi: 10.1038/s41598-022-21223-2.
- Individual participant dataSharing planned: Yes. A public data set will be made available at the end of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cavan Reilly, PhD principal investigator
University of Minnesota
57 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) in people with COVID and SARS-CoV2 Infection, run by University of Minnesota at 57 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Denmark, Uganda, Greece, Argentina and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Stopped for futility - no safety issues.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Status (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04910269, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.