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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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Frequently asked questions about Evolocumab

What is Evolocumab used for in Sars-CoV-2 Infection?

Evolocumab is a small molecule being studied for the treatment of Sars-CoV-2 Infection. It is currently in Phase 3 clinical development. The drug is being investigated for its impact on clinical outcomes in patients during the inflammatory stage of COVID-19.

Who makes Evolocumab?

Evolocumab is being developed by Collegium Pharmaceutical, Inc., which is publicly traded under the ticker symbol COLL. The company is conducting clinical research on this drug for the treatment of Sars-CoV-2 Infection.

What phase is Evolocumab in?

Evolocumab is in Phase 3 clinical development. It is an investigational drug being studied for Sars-CoV-2 Infection. The Phase 3 trial has been completed, and the drug is not yet approved for any use.

What clinical trials is Evolocumab in?

Evolocumab has one completed Phase 3 clinical trial with the identifier NCT04941105. This trial, titled 'Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19', enrolled 60 participants in Poland and was placebo-controlled and double-blind.

Is Evolocumab the same as PCSK9 inhibitors?

Evolocumab is being studied for its impact on PCSK9 inhibition, as indicated by the clinical trial title. The trial specifically evaluates the effect of PCSK9 inhibition on clinical outcomes in COVID-19 patients, suggesting the drug's mechanism involves targeting the PCSK9 pathway.