Recent Updates
Recently added Catalysts

Hyperimmune plasma

Phase 1

SARS-CoV 2 | Monoclonal antibody | Infectious Disease |Design Therapeutics, Inc.|Last Updated: Apr 6, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04366245Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 InfectionPHASE1 COMPLETED 72 — — Apr 23, 2020Dec 30, 2020Apr 6, 202214 Spain
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety: 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).
30 days after enrollment

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).

Efficacy: Death from any cause
Day +21 after randomization
Efficacy: Need for mechanical ventilation
Day +21 after randomization
Efficacy: Any of the following analytical data after 72h of randomization.
Day +21 after randomization

IL-6\> 80 pg / mL, D-dimer\> 10 times, ferritin\> 1000 ng / mL.

Efficacy: SOFA scale ≥ 3 after 72 hours of randomization or an increase of 2 points or more from the basal level
Day +21 after randomization
Secondary Endpoints
Efficacy. Mortality on days 14 and 28.
Days 14 and 28.
Efficacy: Proportion of patients who required mechanical ventilation
Until day 28
Efficacy: Proportion of patients who develop analytical alterations.
Day +21 after randomization.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ExperimentalEXPERIMENTAL -
ComparatorACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Hyperimmune plasmaBIOLOGICALPLASMA OF CONVALESCENT COVID-19
Standard of care for SARS-CoV-2 infectionDRUGStandard of care for SARS-CoV-2 infection
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites14

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...

Countries:Spain
Unlock Eligibility Criteria