Outpatient Treatment With Anti-Coronavirus Immunoglobulin

Launched by UNIVERSITY OF MINNESOTA · Jun 1, 2021

Keywords

ClinConnect Summary

The Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC) trial is studying a new treatment for COVID-19. Specifically, it aims to see if a single infusion of a special type of antibody (called hyperimmune intravenous immunoglobulin or hIVIG) is safe and effective for adults who have recently tested positive for the virus but do not need to be hospitalized. Participants will be monitored for their health status seven days after receiving either the treatment or a placebo (a harmless substance with no active ingredients), allowing researchers to compare the outcomes.

To participate, individuals need to be at least 18 years old and have tested positive for COVID-19 within the last five days. They should also have certain health risks, such as being older than 55 or having conditions that weaken their immune system. Participants will receive the treatment in an outpatient setting, meaning they won’t stay overnight at a hospital. It’s important to know that those who are already receiving other COVID-19 treatments or have certain health conditions may not be eligible for this trial. By joining this study, participants will help researchers understand how well this new treatment works for managing COVID-19 in people who aren’t severely ill.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an immunosuppressed condition.
• • Positive test for SARS-CoV-2 within ≤5 days (if \>1 test, the first positive is within ≤5 days). Tests may include an institutional-based nucleic acid amplification test (NAAT), or any protocol-approved rapid test.
• • Within ≤5 days from symptom onset, if symptomatic from current SARS-CoV-2 infection.
• • Agrees to not participate in another clinical trial for the treatment or management of SARS-CoV-2 infection through Day 7, or until hospitalized or significant disease progression if prior to Day 7 (defined by ordinal category 4 or 5).
• • Participant provides written informed consent prior to study procedures, and understands and agrees to adhere to planned study procedures through Day 28.
• Ongoing immunosuppressive condition or immunosuppressive treatment, includes:
• • 1. Steroids equivalent to prednisone \> 10 mg/day for at least the last 28 days
• • 2. Rheumatologic or autoimmune disorder treated with a biologic or non-biologic immunosuppressive therapy
• • 3. Antirejection medicine after solid organ or stem cell transplantation
• • 4. Cancer treatment with systemic chemotherapy, biologic and/or cell-based therapy in the last 12 months
• • 5. Primary or acquired severe B- or T-lymphocyte immune dysfunction
• • 6. HIV infection
• • 7. Splenectomy or functional asplenia
• Exclusion Criteria:
• • Asymptomatic and had prior symptoms from the current infection that have now resolved (for \>24 hours).
• • Asymptomatic and has received a vaccination for COVID-19 (≥1 dose).
• • Undergoing evaluation for possible admission to hospital for medical management (this does not include evaluation of possible hospitalization for public health purposes).
• • 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).
• • 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).
• * Any of the following thrombotic or procoagulant conditions or disorders:
• • 1. acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep venous thrombosis within 28 days of randomization.
• • 2. prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antiphospholipid syndrome, or a deficiency in antithrombin III, protein C, or protein S.
• • History of hypersensitivity to blood, plasma or IVIG excipients.
• • Known immunoglobulin A (IgA) deficiency or anti-IgA antibodies.
• • 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.