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
Primary Objective
We are conducting a study to compare the safety and efficacy of a single infusion of hyperimmune immunoglobulin (antibodies against COVID-19) versus placebo to prevent progression of COVID-19 in high-risk patients.
Description
This outpatient study involves recently diagnosed COVID-19 patients to determine if a single infusion of antibodies can help prevent disease progression. In this placebo-controlled trial, 50% of participants will receive the antibodies, while the other half will receive saline. Neither the patients nor the study staff will know which group the patients are assigned to. We are focusing on higher-risk patients whose immune systems may not be primed to fight the virus efficiently. Patients will be monitored for 28 days with intermittent follow-up phone calls. Seven days after the infusion, a mobile lab will visit the patient's home to collect additional biospecimen samples (blood, saliva, and nasal swab).
Details
Locations
CTRC Inpatient
University of Colorado Hospital
Principal Investigator
Adit Ginde
Study ID
Protocol Number: 24-0980
Categories
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