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Dupilumab

Phase 2

COVID-19 | Monoclonal antibody | Infectious Disease |Catalyst Pharmaceuticals, Inc.|Last Updated: Nov 3, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Dupilumab · 1 trial · 1 indication

Phase 2 1
NCT04920916Safety and Efficacy of Dupilumab for Treatment of Hospitalized COVID-19 PatientsCOVID-19
COMPLETED40 Analytics
PHASE2COMPLETED
Safety and Efficacy of Dupilumab for Treatment of Hospitalized COVID-19 Patients
COVID-19Unlock trial analytics

Study Endpoints

Primary Endpoints

Day 28 Ventilator Free Survival
at 28 Days ± 2d

Proportion of patients alive and free of invasive mechanical ventilation

Follow up Study 1 Year Outcome: Pulmonary Function Testing- Oxygen Diffusion and 6 Minute Walk Testing
365 ± 90 days

Proportion of patients with abnormal diffusing capacity for carbon monoxide (DLCO) and/or 6 minute walk testing 1 year after acute COVID-19 infection.

Secondary Endpoints

Proportion of Patients With Eosinophilia
Day 0 through Day 60
Cumulative Incidence of Grade 3 and 4 Clinical Adverse Events, Serious Adverse Events (SAEs) or Death
Day 0 through Day 60
SARS-CoV-2 Variants
Day 0
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DupilimabEXPERIMENTALDupilimab: 600 mg, given as two 300 mg subcutaneous injections on day 0/1. If participants are still hospitalized a second and third dose (300 mg) will be given on days 14 and 28.
PlaceboPLACEBO_COMPARATORNormal saline will be given as two one mL subcutaneous injections on day 0/1. If participants are still hospitalized a second and third dose (1 mL) will be given on days 14 and 28.

Interventions

NameTypeDescription
DupilumabBIOLOGICALParticipants will receive a loading dose of dupilumab (600 mg, given as two 300 mg subcutaneous injections) on day 0/1. If participants are still hospitalized a second and third dose (300 mg) will be given on days 14 and 28.
PlaceboDRUGNormal Saline.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female 18 years of age or older at the time of enrollment. * Patients hospitalized with a positive RT-PCR for SARS-CoV-2 within the last 14 days, with illness duration within the last 14 days, and evidence of moderate to severe COVID-19 infection as defined by NIH COVI...

Countries:United States
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Frequently asked questions about Dupilumab

What is Dupilumab used for in COVID-19?

Dupilumab is a monoclonal antibody being investigated for the treatment of hospitalized COVID-19 patients. It is currently in Phase 2 clinical development for this indication. The drug is being studied to evaluate its safety and efficacy in this patient population.

Who makes Dupilumab?

Dupilumab is being developed by Catalyst Pharmaceuticals, Inc., a company traded on the stock exchange under the ticker symbol CPRX. The company is conducting clinical research to assess the drug's potential in treating COVID-19.

What phase is Dupilumab in for COVID-19?

Dupilumab is in Phase 2 clinical development for COVID-19. A Phase 2 clinical trial has been completed to evaluate the drug's safety and efficacy in hospitalized patients with the condition. The drug remains investigational and is not yet approved for this use.

What clinical trials is Dupilumab in for COVID-19?

Dupilumab has been studied in a Phase 2 clinical trial with the identifier NCT04920916, titled 'Safety and Efficacy of Dupilumab for Treatment of Hospitalized COVID-19 Patients'. This trial was completed in the United States and enrolled 40 adult participants.

Is Dupilumab a monoclonal antibody?

Yes, Dupilumab is a monoclonal antibody. It is being evaluated as a potential treatment for COVID-19 in a Phase 2 clinical trial. The trial was a randomized, double-blind, placebo-controlled study involving hospitalized patients.