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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Alejandro
Arenas-Pinto
A.Arenas-Pinto@ucl.ac.uk
Christos
Maniatis
c.maniatis@ucl.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Provisional assignment of new diseases of uncertain etiology
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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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Immunotherapy;
You can take part if:
You may not be able to take part if:
An individual who meets any of the following criteria will be excluded from participation: 1. Asymptomatic and had prior symptoms from the current infection that have now resolved (for > 24 hours). 2. Asymptomatic and has received a vaccination for COVID-19 (> = 1 dose). 3. Undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes). 4. Evidence of pneumonia and/or hypoxia due to COVID-19 (NOTE: chest imaging is not required, but if available it should not show new infiltrates suggestive of pneumonia; hypoxia is defined by new oxygen supplementation or increase above pre-illness level). 5. Prior receipt of immunoglobulin product or passive immune therapy for SARS-CoV-2 in the past 90 days (i.e., convalescent plasma, SARS-CoV-2 monoclonal antibodies, or any IVIG). 6. Any of the following thrombotic or procoagulant conditions or disorders: • acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization. • prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin III, protein C, or protein S. 7. History of hypersensitivity to blood, plasma or IVIG excipients. 8. Known IgA deficiency or anti-IgA antibodies. 9. Medical conditions for which receipt of a 300 mL volume of IV fluid from study treatment may pose specific risk to the patient (e.g., decompensated congestive heart failure). 10. In the opinion of the investigator, any condition for which participation would not be in the best interest of the participant or that could prevent or confound protocol assessments.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Alejandro
Arenas-Pinto
A.Arenas-Pinto@ucl.ac.uk
Christos
Maniatis
c.maniatis@ucl.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Minnesota (USA) and funded by National Institutes of Health (NIH), United States .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 49455
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