Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) [COVID-19]
Research type
Research Study
Full title
An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19
IRAS ID
284872
Contact name
Sarah Pett
Contact email
Sponsor organisation
Office of Sponsored Projects, Regents of the University of Minnesota
Eudract number
2020-002542-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 31 days
Research summary
SARS-CoV-2 is a novel coronavirus causing COVID-19. The virus has spread very rapidly, and safe and effective treatments are urgently needed, especially for those who develop progressive disease, and may die. One antiviral treatment, remdesivir, and an anti-inflammatory drug, dexamethasone, have shown benefit; these are now the standard-of-care treatment for COVID-19.
Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is another potentially useful treatment. It is made from the blood of individuals who have recovered from COVID-19. This blood contains antibodies against the virus. These are concentrated and can be given to people who are ill with COVID-19. It is hoped that by giving these ‘ready-made’ antibodies in addition to the standard-of-care treatments, hospitalised patients will recover even more quickly.
ITAC is an international, randomised double-blind trial in adults hospitalised with COVID-19. ITAC will evaluate whether a single hIVIG infusion in addition to standard-of-care treatment is safe and effective.
Consenting participants will be randomised to receive a single infusion of the hIVIG or matched salt solution placebo. Unless there is a medical reason, it is expected that all participants will receive remdesivir, as a daily infusion for up to 10 days while still in hospital, and dexamethasone.
Participants will be in the trial for 28-90 days. They will be seen on the day of the hIVIG infusion, and then on days 1-3, 5, 7, 14 and 28 to assess their health and take bloods for future COVID-19 research. A blood sample collection at Day 90 is optional, but all UK sites will be asked to complete this.
As we expect the benefit of hIVIG to show up early on, the primary endpoint measurement is on Day 7 of the trial, when we will assess how the patient is doing overall using a 7-point scale. The best points on the scale are being out of hospital.
REC name
London - Fulham Research Ethics Committee
REC reference
20/HRA/4357
Date of REC Opinion
22 Sep 2020
REC opinion
Favourable Opinion