Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC)
About
Treatments are needed to prevent disease progression from COVID-19. This trial will evaluate a passive immunotherapy strategy using hyperimmune intravenous immunoglobulin (hIVIG) among participants with early SARS-CoV2 infection, given in addition to current standard of care (SOC) treatment(s) as available and specified by established national and international guidelines. The primary objective of the Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC) trial is to compare the safety and efficacy of a single infusion of anti-COVID-19 hIVIG + SOC versus placebo + SOC among adults with recently diagnosed SARS-CoV-2 infection who do not require hospitalization. The primary endpoint of this double-blind randomized trial is a 5-category ordinal outcome that assesses participants' clinical status 7 days after infusion of hIVIG or placebo.
Eligibility Criteria
Inclusion Criteria
In order to be eligible to participate in this study, a patient must meet all of the following inclusion criteria prior to randomization:
1. Clinical risk based on age ≥ 55 years or an adult (age ≥ 18 years) with an immunosuppressed condition
2. 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
3. Within ≤5 days from symptom onset, if symptomatic from current SARS-CoV-2 infection
4. 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)
5. Participant provides written informed consent prior to study procedures and understands and agrees to adhere to planned study procedures through Day 28
Exclusion Criteria
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 assessment
Primary Investigator
Lana Wahid, MD, is a hospitalist with over four years of clinical and research experience. She is an assistant professor at the Virginia Tech 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 VTC.
Contact Information
Nkiru Azuogalanya, BA
Clinical Research Coordinator
