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.

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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
Age
Adult
Eligibility
Participants must be at least 55 years old or at least 18 years old with an immunosuppressed condition, and have been diagnosed with COVID-19 within the last five days.Eligible patients can be diagnosed with or without symptoms. If symptomatic, the onset of symptoms must have occurred within the last five days and must not have resolved. Symptoms should not include evidence of pneumonia or hypoxia due to COVID-19. As this is an outpatient study, patients being considered for hospital admission for medical management will be excluded. Additionally, patients with the following conditions will be excluded due to increased risk factors: thrombotic or procoagulant conditions or disorders, history of hypersensitivity to blood or plasma or IVIG excipients, and known IgA deficiency or anti-IgA antibodies. Patients who have received an immunoglobulin product or passive immune therapy for SARS-CoV-2 in the past 90 days will also be excluded.
Locations

CTRC Inpatient
University of Colorado Hospital

Principal Investigator
Photograph of Adit Ginde

Adit Ginde

Study ID

Protocol Number: 24-0980

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