Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04373460 | Convalescent Plasma to Limit SARS-CoV-2 Associated Complications | PHASE2 | COMPLETED | 1,225 | — | — | Jun 3, 2020 | Dec 14, 2022 | Jun 2, 2023 | 29 | United States |
Cumulative Number measured as the proportion of subjects who were hospitalized or who died prior to hospitalization
Cumulative incidence measured as rate per person-years experiencing treatment-related severe infusion reactions during the study period.
Cumulative incidence measured as rate per person-years experiencing a Grade 3 or higher.
Cumulative incidence measured as rate per person-years of treatment-related severe Acute Respiratory Distress Syndrome (ARDS) during the study period.
| Arm | Type | Description |
|---|---|---|
| SARS-CoV-2 convalescent plasma | EXPERIMENTAL | 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. |
| Standard Control plasma | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| SARS-CoV-2 convalescent plasma | BIOLOGICAL | 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 from a volunteer donor | BIOLOGICAL | 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. |
Inclusion Criteria: * ≥ 18 years of age * Competent and capable to provide informed consent * • Positive molecular test for presence of SARS-CoV-2 in fluid collected by saliva for antigen, oropharyngeal or nasopharyngeal swab * Experiencing any symptoms of COVID-19 including but not limited to feve...