Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Plasma · 1 trial · 2 indications
Composite outcome consisting of 28-day all-cause mortality, or 28-day Persistent Organ Dysfunction (POD) requiring support defined as 1) any intravenous vasopressor requirement, or 2) any renal replace therapy, or 3) any ventilator support/mechanical ventilation, or 4) continued need for intensive care unit (ICU) admission at 28 days.
| Arm | Type | Description |
|---|---|---|
| Early Plasma Resuscitation | EXPERIMENTAL | Subjects will receive early plasma resuscitation initiated in the emergency department/burn resuscitation area over an approximate 4-hour period from the time of randomization, stratified by Total Body Surface Area (TBSA)%. |
| Standard Care | ACTIVE_COMPARATOR | Subjects will receive resuscitation following individual site standard burn resuscitation practice. |
| Name | Type | Description |
|---|---|---|
| Plasma | BIOLOGICAL | urgent release early plasma resuscitation following burn/thermal injury |
| Standard care | BIOLOGICAL | Standard resuscitation as dictated by institutional protocol |
Inclusion Criteria: * Estimated ≥ 20% Total Body Surface Area burn/thermal injury with 2nd or 3rd degree depth * Anticipated admission to burn ICU Exclusion Criteria: * Estimated rBaux score \<55 * Not expected to survive \>24 hours * Wearing NO PREEVENT opt-out bracelet * Age \> 75 or \< 18 year...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 2 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| CalciMedica, Inc. | CALC | 1 | PHASE2 | Auxora |
| Talphera, Inc. | TLPH | 1 | N/A | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | - | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | - | Flozin |
Plasma is an investigational therapy being studied for the treatment of burn injury, specifically thermal burns. It is currently in Phase 3 clinical development as a resuscitation fluid aimed at addressing volume and endothelial dysfunction associated with severe burns. The therapy is being evaluated in adult patients in the United States.
Plasma is being developed by United Therapeutics Corporation, a publicly traded biopharmaceutical company listed on NASDAQ under the ticker symbol UTHR. The company is conducting a Phase 3 clinical trial to evaluate the safety and efficacy of Plasma in patients with burn injuries.
Plasma is currently in Phase 3 clinical development for the treatment of burn injury. It is an investigational therapy and has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is designed to assess its efficacy and safety in a large patient population.
Plasma is being evaluated in a Phase 3 clinical trial with the identifier NCT07212998, titled 'Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) Trial.' This randomized, active-controlled study plans to enroll 750 adult patients with burn injuries across the United States.
Yes, Plasma is classified as a monoclonal antibody therapy. It is being investigated for its potential role in burn injury resuscitation, specifically targeting the endothelial dysfunction that occurs after severe thermal burns. The therapy is administered as part of a resuscitation protocol in the ongoing Phase 3 trial.