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
Inpatient Treatment with Anti-Coronavirus Immunoglobulin
What is this study about?
There is an urgent need to find safe and effective treatments for COVID-19, the disease caused by SARS-Cov-2 virus. Passive immunotherapy is one such approach. This is where the antibodies from people who have had the infection and recovered are concentrated into an infusion that is given to people who are ill with COVID-19. This infusion is called hyper immune immunoglobulin (hIVIG). It is hoped that by giving people with COVID-19 these ‘ready-made’ antibodies, they will recover more quickly.
ITAC will evaluate the safety and efficacy of hIVIG treatment in adult patients hospitalised for medical management of COVID-19. Consenting participants will be randomised to either receive a single infusion of the hIVIG or matched placebo (an infusion of a salt solution). There is an equal chance of getting the hIVIG or the matched placebo. All participants will receive the antiviral medication remdesivir unless it is contraindicated for an individual patient.
The duration of the study is between 28 to 90 days. Patients will be seen on the day of the infusion, and then on days 1-3, 5, 7, 14 and 28 to assess their health status and take bloods for future COVID-19 research. There will be an optional visit at day 90 to give an additional blood sample.
Type of study
Who is funding the study?
National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) and carried out by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT).
When is it taking place?
July 2020 onwards
Where is it taking place?
This is an international study with multiple sites in the Northern and Southern Hemisphere. The MRC CTU at UCL are overseeing sites in the UK, France, and Greece.
Who is included?
This study will enrol 500 hospitalised adults with mild or moderate COVID-19 who have had symptoms for 12 days or less.