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Kamada Anti-SARS-CoV-2

Phase 1

Covid19 | Monoclonal antibody | Infectious Disease |Kamada Ltd.|Last Updated: Jan 5, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04550325Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19PHASE1 COMPLETED 12Aug 5, 2020Nov 26, 2020Jan 5, 20214 Israel
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Study Endpoints
Primary Endpoints
Adverse events, serious adverse events, and deaths
14 days

Record adverse events, serious adverse events, and deaths

Secondary Endpoints
AUC0-7 of Anti SARS CoV-2 antibodies
7 days
Neutralization activity
7 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Immune gamma globulin (IgG)EXPERIMENTALSingle dose of 4g Immune gamma globulin (IgG) preparation Kamada Anti-SARS-CoV-2 given as an intravenous infusion
Interventions
NameTypeDescription
Kamada Anti-SARS-CoV-2BIOLOGICALAnti-SARS-CoV-2 is a preparation of immune gamma globulin manufactured from convalescent plasma of COVID-19 recovered patients, using Kamada's proprietary purification methods
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Age ≥ 18 years 2. Laboratory confirmed SARS-CoV-2 infection by nasopharyngeal swab Real time polymerase chain reaction (RT-PCR) 3. Hospitalized for COVID-19 pneumonia 4. Dosing should be within 10 days of symptom start 5. Able and willing to sign informed consent form Exclus...

Countries:Israel
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