drugset / Trial / NCT04546581
Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)
Phase 3
Completed
593 enrolled
University of Minnesota
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for an individual patient.
Timeline
- Start
- 2020-10-08
- Primary completion
- 2021-05-21
- Completion
- 2021-05-21
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.
- ITAC (INSIGHT 013) Study Group. Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial. Lancet. 2022 Feb 5;399(10324):530-540. doi: 10.1016/S0140-6736(22)00101-5. Epub 2022 Jan 28.
- Vandeberg P, Cruz M, Diez JM, Merritt WK, Santos B, Trukawinski S, Wellhouse A, Jose M, Willis T. Production of anti-SARS-CoV-2 hyperimmune globulin from convalescent plasma. Transfusion. 2021 Jun;61(6):1705-1709. doi: 10.1111/trf.16378. Epub 2021 Mar 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | COVID-HIGIV | Protein / enzyme biologic | — | Intravenous |
| Background | Remdesivir | Small molecule | — | — |