Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)

PHASE3CompletedINTERVENTIONAL
Enrollment

593

Participants

Timeline

Start Date

October 8, 2020

Primary Completion Date

May 21, 2021

Study Completion Date

May 21, 2021

Conditions
COVIDCOVID-19SARS-CoV-2SARS (Severe Acute Respiratory Syndrome)
Interventions
BIOLOGICAL

Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)

Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.

OTHER

Placebo

Participants will receive a single infusion of the placebo (saline).

DRUG

Remdesivir

Remdesivir will be given to participants in both groups as standard of care (SOC).

Trial Locations (39)

3400

Nordsjællands Hospital, Hillerød, Hillerød

11527

3rd Dept of Medicine, Medical School, NKUA, Athens

20422

Washington VA Medical Center, Washington D.C.

20892

National Institutes of Health Clinical Center, Bethesda

23225

CJW Chippenham Medical Center, Richmond

23229

Henrico Doctors' Hospital (HCA), Richmond

28394

FirstHealth Moore Regional Hospital, Pinehurst

30165

Redmond Regional Medical Center, Rome

43215

Ohio Health Research Institute, Columbus

55415

Hennepin Healthcare Research Institute/HCMC, Minneapolis

65212

University of Missouri, Columbia

65807

Cox Medical Centers, Springfield

68131

Democritus University of Thrace, Alexandroupoli

75235

University of Texas Southwestern Medical Center, Dallas

78404

CHRISTUS Spohn Shoreline Hospital, Corpus Christi

79601

Hendrick Medical Center, Abilene

80023

Saint Anthony North Health Campus, Westminster

80228

St. Anthony Hospital, Lakewood

80907

Penrose Hospital, Colorado Springs

St. Francis Health Services, Colorado Springs

01665

University of Massachusetts, Worcester

Unknown

Aarhus Universitetshospital, Skejby, Aarhus

Bispebjerg Hospital, Copenhagen

CHIP, Department of Infectious Diseases, Section 2100, Copenhagen

Herlev-Gentofte Hospital, Hellerup

Hvidovre University Hospital, Department of Infectious Diseases, Hvidovre

Kolding Sygehus, Kolding

Odense University Hospital, Odense

1st Respiratory Medicine Dept, Athens University Medical School, Athens

Attikon University General Hospital, Athens

Dept. of Critical Care & Pulmonary Medicine, Evangelismos General Hospital, Athens

NCGM, Tokyo

Fujita Health University Hospital, Toyoake

Institute of Human Virology-Nigeria (IHVN), Abuja

Royal Free Hospital, London

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08002

Hospital del Mar, Barcelona

08036

Hospital Clínic de Barcelona, Barcelona

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

NCT04546581 - Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC) | Biotech Hunter | Biotech Hunter