OTAC
Outpatient Treatment with Anti-Coronavirus Immunoglobulin in people at higher risk for severe COVID-19
Can giving an infusion of anti-coronavirus antibodies help people at higher risk of severe COVID-19 stay out of hospital and avoid complications?
What is this study about?
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 are considered at higher risk of developing severe COVID-19. 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 hIVIG can help people stay out of hospital and results in fewer complications associated with COVID-19.
Anti-coronavirus hIVIG contains antibodies against SARS-CoV-2, 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 hIVIG or matching placebo in an outpatient setting.
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 an in-person study visit 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 blood oxygen saturation (SpO2) measurements using a portable oximeter at home.
Type of study
Randomised trial
Contact details
Who is funding the study?
The study is funded by the National Institute for Allergy and Infectious Diseases, US National Institutes of Health and carried out by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT).
When is it taking place?
The study opened in May 2021.
Where is it taking place?
This is an international study with multiple sites in the northern and southern hemisphere. The MRC CTU at UCL is overseeing sites in the UK, Uganda and Greece.
Who is included?
The target population includes adults ≥55 years of age, or adults ≥18 years of age who have an immunosuppressive condition, who recently tested positive for SARS-CoV-2 infection, who are either symptomatic or asymptomatic (if never vaccinated), and who meet all eligibility criteria. Participants must be ≤ 5 days from both positive SARS-CoV-2 testing and symptom onset (if symptomatic).