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Evolocumab

Phase 3

Sars-CoV-2 Infection | Small molecule | Infectious Disease |Collegium Pharmaceutical, Inc.|Last Updated: Apr 21, 2023

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical trial landscape

Evolocumab · 1 trial · 1 indication

Phase 3 1
NCT04941105Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19Sars-CoV-2 Infection
COMPLETED60 Analytics
PHASE3COMPLETED
Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19
Sars-CoV-2 InfectionUnlock trial analytics
Study Endpoints
Primary Endpoints
Death from any cause or need for intubation
during hospitalization, up to 30 days

Indication for intubation determined individually for each patient and clinical status

Secondary Endpoints
Change in serum interleukin-6 concentration from day 0 to day 7 and day 30
7 and 30 days from randomization
Death from any cause
during hospitalization, up to 30 days
Need for intubation
during hospitalization, up to 30 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PCSK9 inhibitor (evolocumab)EXPERIMENTAL140 mg of evolocumab as a single subcutaneous injection and standard of care accordance to the latest recommendations
Usual CarePLACEBO_COMPARATOR1 ml of 0,9% saline solution as a single subcutaneous injection. Patients will be treated in accordance to the latest recommendations on caring for patients infected with SARS-CoV-2.
Interventions
NameTypeDescription
EvolocumabDRUGA single subcutaneous administration of 140 mg evolocumab
Saline solutionDRUGA single subcutaneous injection of 1ml of 0,9% saline solution
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Written informed consent for participation in the study 2. Male and female age 18 or more at the time of signing the informed consent 3. SARS-CoV-2 infection confirmed by Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) 4. COVID-19 pneumonia with a typical r...

Countries:Poland
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