Villa Regina

Researchers are evaluating the safety and effectiveness of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG) compared to a placebo in adults recently diagnosed with SARS-CoV-2 infection who do not need hospitalization. This Phase 3, double-blind, randomized trial aims to assess participants' clinical status seven days after treatment using a five-category scale ranging from no symptoms to critical illness or death. The study also examines outcomes in two groups: those receiving other approved antiviral treatments and those who are not. Participants receive either a single 3.5-gram infusion of hIVIG or a 35-milliliter infusion of saline placebo, with equal chance of assignment to each group. The randomization is stratified by study site and whether participants are receiving standard antiviral care. The infusion occurs once, and participants are monitored thereafter to compare the effects of hIVIG plus standard care versus placebo plus standard care. During the study, participants provide written consent and agree to follow study procedures through 28 days. Researchers assess clinical status seven days after infusion and track safety and disease progression. The study excludes those with prior immune therapies or certain medical conditions and requires participants to avoid other COVID-19 treatment trials through Day 7 unless hospitalized or experiencing significant disease worsening. Clinical assessments and monitoring continue to ensure participant safety and capture outcomes related to COVID-19 illness severity.