Recent Updates
Recently added Catalysts

Kamada Anti-SARS-CoV-2

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Kamada Anti-SARS-CoV-2 · 1 trial · 2 indications

Phase 1 1
NCT04550325Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19Covid19
COMPLETED12 Analytics
PHASE1COMPLETED
Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19
Covid19Unlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about Kamada Anti-SARS-CoV-2

What is Kamada Anti-SARS-CoV-2 used for?

Kamada Anti-SARS-CoV-2 is an investigational monoclonal antibody being developed for COVID-19. It is intended to treat the viral infection and associated pneumonia caused by SARS-CoV-2. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Kamada Anti-SARS-CoV-2?

Kamada Anti-SARS-CoV-2 is being developed by Kamada Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KMDA. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this monoclonal antibody in patients with COVID-19.

What phase is Kamada Anti-SARS-CoV-2 in?

Kamada Anti-SARS-CoV-2 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It is not approved for commercial use, and further clinical studies would be needed to establish its safety and efficacy.

What clinical trials is Kamada Anti-SARS-CoV-2 in?

Kamada Anti-SARS-CoV-2 has one completed Phase 1 trial, registered as NCT04550325, titled "Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19." The study enrolled 12 participants in Israel and evaluated the drug's safety, pharmacokinetics, and pharmacodynamics in patients with COVID-19 and viral pneumonia.

How does Kamada Anti-SARS-CoV-2 work?

Kamada Anti-SARS-CoV-2 is a monoclonal antibody designed to target the SARS-CoV-2 virus, the pathogen that causes COVID-19. By binding to the virus, the antibody is intended to neutralize it and prevent it from infecting human cells, potentially reducing viral load and disease severity.