Efficacy of COVID-HIGIV in animal models of SARS-CoV-2 infection.
Aruni Jha, Douglas Barker, Jocelyne Lew...
https://pubmed.ncbi.nlm.nih.gov/36216961Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID04910269
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
Led by University of Minnesota · Updated on 2026-04-20
820
Participants Needed
66
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Minnesota
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness 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 need hospitalization. This is a randomized, double-blind trial aiming to assess clinical status seven days after treatment using a five-category scale ranging from no symptoms to critical illness or death. The study also considers participants receiving standard antiviral treatments separately for analysis. Participants will be randomly assigned to receive either a single dose of 3.5 grams of hIVIG or a placebo infusion of 35 milliliters of saline. Both groups will continue to receive standard care. Randomization is stratified by site pharmacy and whether participants are receiving certain antiviral agents. This trial includes two groups: those receiving additional antiviral treatments and those not receiving them. During the study, participants will be monitored for their clinical status at day 7 as the primary outcome. Secondary outcomes include hospitalization, mortality, disease progression, viral load changes, antibody levels, and healthcare use assessed up to 28 days. Participants must provide informed consent and adhere to study procedures, with follow-up evaluations scheduled to measure safety and efficacy over the trial period ending in August 2026.
CONDITIONS
Brief Title
Outpatient Treatment With Anti-Coronavirus Immunoglobulin
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Clinical risk based on age 55 years or older or an adult 18 years or older with an immunosuppressed condition
- Positive SARS-CoV-2 test within 5 days (first positive if multiple tests)
- Symptom onset within 5 days if symptomatic
- Willing to not participate in another COVID-19 treatment trial through Day 7 or until hospitalization/significant disease progression
- Provides written informed consent and agrees to follow study procedures through Day 28
- Immunosuppressive conditions include recent high-dose steroids, autoimmune disorders on immunosuppressive therapy, post-transplant antirejection medication, recent cancer treatment, immune dysfunction, HIV, or asplenia
You will not qualify if you...
- Asymptomatic with prior resolved symptoms for more than 24 hours
- Asymptomatic and received at least one dose of COVID-19 vaccine
- Under evaluation for hospital admission for medical reasons
- Evidence of pneumonia or hypoxia related to COVID-19
- Receipt of immunoglobulin or passive immune therapy for COVID-19 in past 90 days
- Recent thrombotic or procoagulant conditions within 28 days
- History of hypersensitivity to blood products or IVIG excipients
- Known IgA deficiency or anti-IgA antibodies
- Any condition that investigator believes would prevent safe participation or confound study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single day
Participants receive a single infusion of either the investigational hyperimmune immunoglobulin or placebo alongside standard of care.
1 treatment visit (in-person)
Follow-up
Duration - 28 days
Participants are monitored for clinical status, disease progression, and safety outcomes through 28 days after treatment.
Multiple follow-up visits up to 28 days
Trial Site Locations
Total: 66 locations
1
Southern Arizona VA Healthcare System (074-009)
Tucson, Arizona, United States, 85723
Terminated
2
VA Northern California Health Care System (074-023)
Mather, California, United States, 95655
Terminated
3
Stanford University Hospital & Clinics (Site 203-003)
Palo Alto, California, United States, 94305
Actively Recruiting
4
San Francisco VAMC (Site 074-002)
San Francisco, California, United States, 94121
Terminated
5
Rocky Mountain Regional VA Medical Center (074-010)
Aurora, Colorado, United States, 80045
Terminated
6
MedStar Health Research Institute
Washington D.C., District of Columbia, United States, 20010
Withdrawn
7
Washington DC Veterans Affairs Medical Center
Washington D.C., District of Columbia, United States, 20422
Withdrawn
8
University of Maryland Medical System
Baltimore, Maryland, United States, 21201
Withdrawn
9
Henry Ford Health System Site (014-001)
Detroit, Michigan, United States, 48202
Actively Recruiting
10
Infusion Associates
Grand Rapids, Michigan, United States, 49525
Withdrawn
11
Mount Sinai Beth Israel Hospital
New York, New York, United States, 10003
Withdrawn
12
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Terminated
13
Cleveland Clinic Foundation (Site 207-001)
Cleveland, Ohio, United States, 44195
Actively Recruiting
14
Penn State Health Milton S. Hershey Medical Center (209-002)
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
15
Hendrick Medical Center
Abilene, Texas, United States, 79601
Withdrawn
16
CHRISTUS Spohn Shoreline Hospital
Corpus Christi, Texas, United States, 78404
Actively Recruiting
17
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
18
Intermountain Medical Center (211-001)
Murray, Utah, United States, 84107
Actively Recruiting
19
UVA Health System, University Hospital (Site 210-003)
Charlottesville, Virginia, United States, 22908
Actively Recruiting
20
Carilion Medical Center (Site 080-018)
Roanoke, Virginia, United States, 24015
Actively Recruiting
21
Salem VA Medical Center (074-014)
Salem, Virginia, United States, 24153
Terminated
22
Swedish Hospital First Hill
Seattle, Washington, United States, 98122
Actively Recruiting
23
Instituto Medico Platense
La Plata, Buenos Aires, Argentina, B1900AVG
Actively Recruiting
24
Centro de Investigaciones Medicas de Mar del Plata (Site 611-031)
Mar del Plata, Buenos Aires, Argentina, B7600FYK
Actively Recruiting
25
Clínica Central S.A. (611-028)
Villa Regina, Río Negro Province, Argentina, R8336
Actively Recruiting
26
Hospital General de Agudos JM Ramos Mejia
Buenos Aires, Argentina, C1221ADC
Actively Recruiting
27
St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Actively Recruiting
28
Odense University Hospital
Odense, C, Denmark, 5000
Actively Recruiting
29
Aarhus Universitetshospital, Skejby
Aarhus, N, Denmark, 8200
Actively Recruiting
30
Department of Infectious Diseases
Aalborg, Denmark, 9000
Actively Recruiting
31
Rigshospitalet, CHIP
Copenhagen, Denmark, 2100
Actively Recruiting
32
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Actively Recruiting
33
Herlev/Gentofte Hospital
Hellerup, Denmark, 2900
Actively Recruiting
34
Hvidovre University Hospital, Department of Infectious Diseases
Hvidovre, Denmark, 2650
Actively Recruiting
35
Kolding Sygehus
Kolding, Denmark, 6000
Actively Recruiting
36
Dept of Critical Care and Pulmonary Medicine, Evangelismos General Hospital
Athens, Attica, Greece, 10676
Actively Recruiting
37
3rd Dept of Medicine, Medical School
Athens, Attica, Greece, 11527
Actively Recruiting
38
Laiko Athens General Hospital
Athens, Attica, Greece, 11527
Actively Recruiting
39
Department of Clinical Therapeutics of Alexandra Hospital
Athens, Attica, Greece, 11528
Actively Recruiting
40
4th Department of Internal Medicine
Athens, Attica, Greece, 12462
Actively Recruiting
41
All India Institute of Medical Sciences (AIIMS)
Jodhpur, Rajasthan, India, 342005
Withdrawn
42
Postgraduate Institute of Medical Education and Research (PGIMER)
Chandigarh, India, 160012
Withdrawn
43
University Malaya Medical Centre (Site 612-501)
Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
Actively Recruiting
44
Hospital General Dr. Manuel Gea Gonzáles
Mexico City, Mexico City, Mexico, 14080
Actively Recruiting
45
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, Mexico, 14080
Actively Recruiting
46
Instituto Nacional de Enfermedades Respiratorias Ismael Cosió Villegas
Mexico City, Mexico City, Mexico, 14080
Actively Recruiting
47
CHRISTUS Centro de Excelencia en Investigacion (Obispado)
Monterrey, Nuevo León, Mexico, 64060
Withdrawn
48
Hospital General Dr. Aurelio Valdivieso
Oaxaca City, OA, Mexico, 68050
Actively Recruiting
49
Unidad de Ensayos Clinicos Socios En Salud Sucursal Perú (651-009)
Lima, Peru, 15012
Actively Recruiting
50
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
51
CAP Can Bou
Castelldefels, Barcelona, Spain, 08860
Actively Recruiting
52
CAP El Maresme
Mataró, Barcelona, Spain, 08303
Actively Recruiting
53
CAP Corbera
Barcelona, Spain, 08757
Actively Recruiting
54
Siriraj Hospital (Site 613-002)
Bangkok Noi, Bangkok, Thailand, 10700
Actively Recruiting
55
Chulalongkorn University and The HIV-NAT
Pathum Wan, Bangkok, Thailand, 10330
Actively Recruiting
56
Khon Kaen University, Srinagarind Hospital (Site 613-003)
Khon Kaen, Thailand, 40002
Actively Recruiting
57
Bamrasnaradura Infections Diseases Institute (613-007)
Nonthaburi, Thailand, 11000
Actively Recruiting
58
MRC/UVRI & LSHTM Uganda Research Unit
Entebbe, Uganda
Actively Recruiting
59
Joint Clinical Research Center (JCRC)
Kampala, Uganda
Actively Recruiting
60
Makerere University Lung Institute (Site 634-604)
Kampala, Uganda
Actively Recruiting
61
St. Francis Hospital, Nsambya
Kampala, Uganda
Actively Recruiting
62
Lira Regional Referral Hospital
Lira, Uganda
Actively Recruiting
63
Masaka Regional Referral Hospital
Masaka, Uganda
Actively Recruiting
64
Central City Clinical Hospital of Ivano-Frankivsk City Council
Ivano-Frankivsk, Ukraine, 76018
Actively Recruiting
65
University College London Hospitals
London, United Kingdom, WC1E 6JB
Actively Recruiting
66
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Actively Recruiting
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Research Team
R
Rebecca Schoenecker, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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