Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC)
Research type
Research Study
Full title
An International Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19
IRAS ID
296598
Contact name
Alejandro Arenas-Pinto
Contact email
Sponsor organisation
Office of Sponsored Projects,University of Minnesota
Eudract number
2021-001663-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
OTAC is an international, randomised double-blind trial in adults recently diagnosed with SARS-CoV-2 infection who do not require hospitalisation.
The trial aims to compare the safety and efficacy of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) versus placebo among adults who meet the inclusion criteria to be part of the study. It is expected that this would be given in addition to any other standard of care that is available at the time.
We are also trying to find out if giving anti-coronavirus hyperimmune intravenous immunoglobulin (hIVIG) can help people stay out of hospital and result in them having fewer negative effects from COVID-19. Anti-coronavirus hIVIG contains antibodies against the virus that causes COVID-19. We think that this can help individuals fight the disease. Our intended patient population has a higher risk of getting very sick with COVID-19. This is because of their age or a medical condition.
Consenting patients will receive a single infusion of hyperimmune intravenous immunoglobulin (hIVIG) or matching placebo in an outpatient setting. This will either be at home or in a clinical setting, but not as an in-patient.
Patients will be closely monitored during the infusion and observed for a period of time immediately after. The duration of the follow up period for the study is 28 days. All participants will be contacted at Day 1, 4, 7, 14 and 28 (with in-person specimen collection occurring at Day 7). During the follow up period, patients will self-record any interference with regular or usual daily life activities and self-evaluate any symptoms they may have. On a daily basis patients will record their SpO2 measurements using a portable oximeter at home.
REC name
London - Fulham Research Ethics Committee
REC reference
21/HRA/2079
Date of REC Opinion
1 Jun 2021
REC opinion
Further Information Favourable Opinion