Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SARS-CoV-2 convalescent plasma · 1 trial · 1 indication
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...
SARS-CoV-2 convalescent plasma is used for SARS-CoV-2, the virus that causes COVID-19. It is an investigational therapy being studied to limit complications associated with the infection. The treatment involves plasma from recovered patients, which may contain antibodies against the virus.
SARS-CoV-2 convalescent plasma is being developed by United Therapeutics Corporation, a company traded on the NASDAQ under the ticker UTHR. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy for patients with SARS-CoV-2.
SARS-CoV-2 convalescent plasma is in Phase 2 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. A Phase 2 trial has been completed to assess its effects in patients with SARS-CoV-2.
SARS-CoV-2 convalescent plasma has one completed clinical trial, NCT04373460, titled 'Convalescent Plasma to Limit SARS-CoV-2 Associated Complications.' This Phase 2 study enrolled 1,225 participants in the United States and was a randomized, double-blind, active-controlled trial.
SARS-CoV-2 convalescent plasma is the same as COVID-19 convalescent plasma, as SARS-CoV-2 is the virus that causes COVID-19. The therapy uses plasma from recovered patients and is being studied for its potential to limit complications in infected individuals.