Outpatient Treatment With Anti-Coronavirus Immunoglobulin

PHASE3RecruitingINTERVENTIONAL
Enrollment

820

Participants

Timeline

Start Date

August 6, 2021

Primary Completion Date

August 1, 2026

Study Completion Date

August 1, 2026

Conditions
COVIDSARS-CoV2 InfectionCovid19
Interventions
BIOLOGICAL

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.

OTHER

Placebo

Infusion of 35 milliliters standard isotonic saline

Trial Locations (64)

2010

RECRUITING

St. Vincent's Hospital, Sydney

2100

RECRUITING

Rigshospitalet, CHIP, Copenhagen

2400

RECRUITING

Bispebjerg Hospital, Copenhagen

2650

RECRUITING

Hvidovre University Hospital, Department of Infectious Diseases, Hvidovre

2900

RECRUITING

Herlev/Gentofte Hospital, Hellerup

5000

RECRUITING

Odense University Hospital, Odense

6000

RECRUITING

Kolding Sygehus, Kolding

8200

RECRUITING

Aarhus Universitetshospital, Skejby, Aarhus

9000

RECRUITING

Department of Infectious Diseases, Aalborg

10003

WITHDRAWN

Mount Sinai Beth Israel Hospital, New York

10029

TERMINATED

Icahn School of Medicine at Mount Sinai, New York

10330

RECRUITING

Chulalongkorn University and The HIV-NAT, Pathum Wan

10676

RECRUITING

Dept of Critical Care and Pulmonary Medicine, Evangelismos General Hospital, Athens

10700

RECRUITING

Siriraj Hospital (Site 613-002), Bangkok Noi

11000

RECRUITING

Bamrasnaradura Infections Diseases Institute (613-007), Nonthaburi

11527

RECRUITING

3rd Dept of Medicine, Medical School, Athens

RECRUITING

Laiko Athens General Hospital, Athens

11528

RECRUITING

Department of Clinical Therapeutics of Alexandra Hospital, Athens

12462

RECRUITING

4th Department of Internal Medicine, Athens

14080

RECRUITING

Hospital General Dr. Manuel Gea Gonzáles, Mexico City

RECRUITING

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City

RECRUITING

Instituto Nacional de Enfermedades Respiratorias Ismael Cosió Villegas, Mexico City

15012

RECRUITING

Unidad de Ensayos Clinicos Socios En Salud Sucursal Perú (651-009), Lima

17033

RECRUITING

Penn State Health Milton S. Hershey Medical Center (209-002), Hershey

20010

WITHDRAWN

MedStar Health Research Institute, Washington D.C.

20422

WITHDRAWN

Washington DC Veterans Affairs Medical Center, Washington D.C.

21201

WITHDRAWN

University of Maryland Medical System, Baltimore

24015

RECRUITING

Carilion Medical Center (Site 080-018), Roanoke

24153

RECRUITING

Salem VA Medical Center (074-014), Salem

40002

RECRUITING

Khon Kaen University, Srinagarind Hospital (Site 613-003), Khon Kaen

44195

RECRUITING

Cleveland Clinic Foundation (Site 207-001), Cleveland

48202

RECRUITING

Henry Ford Health System Site (014-001), Detroit

49525

WITHDRAWN

Infusion Associates, Grand Rapids

64060

WITHDRAWN

CHRISTUS Centro de Excelencia en Investigacion (Obispado), Monterrey

68050

RECRUITING

Hospital General Dr. Aurelio Valdivieso, Oaxaca City

75390

RECRUITING

UT Southwestern Medical Center, Dallas

76018

RECRUITING

Central City Clinical Hospital of Ivano-Frankivsk City Council, Ivano-Frankivsk

78404

RECRUITING

CHRISTUS Spohn Shoreline Hospital, Corpus Christi

79601

WITHDRAWN

Hendrick Medical Center, Abilene

80045

RECRUITING

Rocky Mountain Regional VA Medical Center (074-010), Aurora

84107

RECRUITING

Intermountain Medical Center (211-001), Murray

85723

RECRUITING

Southern Arizona VA Healthcare System (074-009), Tucson

94121

RECRUITING

San Francisco VAMC (Site 074-002), San Francisco

94305

RECRUITING

Stanford University Hospital & Clinics (Site 203-003), Palo Alto

95655

RECRUITING

VA Northern California Health Care System (074-023), Mather

98122

RECRUITING

Swedish Hospital First Hill, Seattle

160012

WITHDRAWN

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

342005

WITHDRAWN

All India Institute of Medical Sciences (AIIMS), Jodhpur

B1900AVG

RECRUITING

Instituto Medico Platense, La Plata

B7600FYK

RECRUITING

Centro de Investigaciones Medicas de Mar del Plata (Site 611-031), Mar del Plata

R8336

RECRUITING

Clínica Central S.A. (611-028), Villa Regina

C1221ADC

RECRUITING

Hospital General de Agudos JM Ramos Mejia, Buenos Aires

08916

RECRUITING

Hospital Universitari Germans Trias i Pujol, Badalona

08860

RECRUITING

CAP Can Bou, Castelldefels

08303

RECRUITING

CAP El Maresme, Mataró

08757

RECRUITING

CAP Corbera, Barcelona

Unknown

RECRUITING

MRC/UVRI & LSHTM Uganda Research Unit, Entebbe

RECRUITING

Joint Clinical Research Center (JCRC), Kampala

RECRUITING

Makerere University Lung Institute (Site 634-604), Kampala

RECRUITING

St. Francis Hospital, Nsambya, Kampala

RECRUITING

Lira Regional Referral Hospital, Lira

RECRUITING

Masaka Regional Referral Hospital, Masaka

WC1E 6JB

RECRUITING

University College London Hospitals, London

NE1 4LP

RECRUITING

Royal Victoria Infirmary, Newcastle upon Tyne

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

National Institutes of Health (NIH)

NIH

collaborator

International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

NETWORK

lead

University of Minnesota

OTHER