OTAC
The goal of OTAC is to assess the safety and efficacy of a single outpatient infusion of hyperimmune intravenous immunoglobulin (hIVIG) in adults recently diagnosed with COVID-19.
About This Study
Summary
More than 80% of people who get coronavirus disease 2019 (COVID-19) have mild to moderate illness that may include cough, sore throat, weakness, and fatigue. However, starting treatment for COVID-19 before any of these symptoms develop may decrease the risk of severe disease, including low blood oxygen levels and pneumonia. In addition, treating COVID-19 while it’s in the early stages could decrease the number of people who are hospitalized and may help keep the disease from spreading.
The OTAC study evaluates whether adding anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) to the standard treatment protocol is safe and effective in patients newly diagnosed with COVID-19 and who don’t need to be hospitalized. Anti-COVID-19 hIVIG contains antibodies that neutralize the virus that causes COVID-19, potentially boosting a patient’s immunity and preventing disease progression.
While being treated for COVID-19, participants in OTAC are assigned randomly (50-50, like a coin toss) to also receive either the study product (hIVIG) or something that looks like it but doesn't contain any medicine (placebo). Neither the lead scientist nor the participant knows or can choose which group they're in. Both the drug and the placebo are given once, in fluids delivered into a vein (intravenous infusion). Participation in OTAC (including follow-up surveys) lasts approximately 28 days in total.
To be included in OTAC, participants must have / be:
- Adults (at least 55 years old OR at least 18 years old with an immunosuppressive condition)
- Tested positive for SARS-CoV-2 infection (the virus that causes COVID-19) within the previous 5 days
- Developed disease symptoms (if present) within the previous 5 days
To be included in OTAC, participants must not have / be:
- Symptoms from the current infection that have since resolved
- Hospitalized
- Received COVID-19 vaccine (1 or more doses)
- Pneumonia and/or hypoxia due to COVID-19
Keywords
COVID; Respiratory disease
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Lana Wahid, MD, is a hospitalist with more than 4 years of clinical and research experience. She's an assistant professor at the Virginia Tech Carilion School of Medicine, medical director for inpatient clinical trials, and vice chair of research for the Department of Medicine. She completed her internship in general surgery from the University of North Carolina followed by her residency in internal medicine at VTCSOM.
Official title of study
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
Funding mechanism
Sponsored by the University of Minnesota
Funded by the National Institute of Allergy and Infectious Disease, NIH and the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)