Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hyperimmune plasma · 1 trial · 1 indication
Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).
IL-6\> 80 pg / mL, D-dimer\> 10 times, ferritin\> 1000 ng / mL.
| Arm | Type | Description |
|---|---|---|
| Experimental | EXPERIMENTAL | - |
| Comparator | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Hyperimmune plasma | BIOLOGICAL | PLASMA OF CONVALESCENT COVID-19 |
| Standard of care for SARS-CoV-2 infection | DRUG | Standard of care for SARS-CoV-2 infection |
Inclusion Criteria: 1. Informed consent prior to performing procedures. the oral consent be accepted testified to prevent paper handling. 2. Patient of both sexes, and ≥18 years. 3. SARS-CoV-2 infection determined by PCR in a sample of naso-oropharyngeal exudate or other respiratory specimen or det...
Hyperimmune plasma is an investigational monoclonal antibody therapy being studied for the treatment of SARS-CoV 2, the virus that causes COVID-19. It is derived from convalescent antibodies obtained from individuals who have recovered from COVID-19 infection. The therapy is currently in Phase 1 clinical development.
Hyperimmune plasma is being developed by Design Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol DSGN. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy for SARS-CoV 2 infection.
Hyperimmune plasma is in Phase 1 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the therapy remains under investigation for the treatment of SARS-CoV 2.
Hyperimmune plasma has one completed clinical trial registered under NCT04366245, titled 'Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection.' This Phase 1 study enrolled 72 participants in Spain and included adults aged 18 years and older.
Hyperimmune plasma is a type of convalescent plasma therapy. It is obtained from the blood of individuals who have recovered from COVID-19 and contains antibodies against the SARS-CoV 2 virus. The therapy is being studied as a potential treatment for COVID-19 infection.