To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.
The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the efficacy of treatment with HCIP in reducing hospitalization and death prior to hospitalization among outpatient adults who have RNA detection test-confirmed COVID-19 AND have developed any symptoms of COVID-19 including but not limited to fever, cough, or other COVID associated symptoms like anosmia. Ambulatory/outpatient adults subjects 18 years of age or older, regardless of risk factors for severe illness may participate. A total of approximately 1344 eligible subjects stratified with a target goal (but not binding) of 50:50 in the \<65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,225
SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.
Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.
Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization
Cumulative Number measured as the proportion of subjects who were hospitalized or who died prior to hospitalization
Time frame: Up to day 28
Cumulative Incidence of Severe Infusion Reactions
Cumulative incidence measured as rate per person-years experiencing treatment-related severe infusion reactions during the study period.
Time frame: Up to day 28
Cumulative Incidence of Treatment-related Grade 3 or Higher Adverse Events
Cumulative incidence measured as rate per person-years experiencing a Grade 3 or higher.
Time frame: Up to day 90
Cumulative Incidence of Treatment-related Acute Respiratory Distress Syndrome (ARDS)
Cumulative incidence measured as rate per person-years of treatment-related severe Acute Respiratory Distress Syndrome (ARDS) during the study period.
Time frame: Up to day 28
Serum SARS-CoV-2 Antibody Titers by Visit
Geometric mean Spike Receptor Binding Domain (RBD) titers at day 0, 14, 28 and 90 between the randomized arms.
Time frame: Days 0, 14, 28 and 90
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Danbury, Connecticut, United States
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