Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC) (INSIGHT 012)
Coronavirus disease 2019 (COVID-19) is a predominantly respiratory disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and causes substantial morbidity and mortality. It is plausible that initiation of therapy early in the course of COVID-19, and before overt clinical symptoms and signs of pneumonia requiring hospitalization have developed, may reduce the subsequent risk of disease progression to pneumonia with hypoxia, hospitalization and death.
Therefore, this trial evaluates a passive immunotherapy strategy in hyperimmune intravenous immunoglobulin (hIVIG) among participants with early SARS-CoV-2 infection, given in addition to current standard of care (SOC) treatment(s) as available and specified by established national and international guidelines (e.g., the National Institutes of Health (NIH) COVID-19 Treatment Guidelines, or the World Health Organization (WHO) Therapeutics and COVID-19 Guidelines).
The primary objective of the trial is to compare the safety and efficacy of a single infusion of anti-COVID-19 hIVIG versus placebo among adults (ages ≥18years, ≥55years), with recently diagnosed SARS-CoV-2 infection who do not require hospitalization.
Expected impact: The hIVIG may be an efficacious SARS-CoV-2 agent, with greater neutralizing potency compared to convalescent plasma, reducing the risk of disease progression to pneumonia with hypoxia, hospitalization and death.
