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A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19.
Sponsor: Inmunova S.A.
Summary
This study aims to analyze the efficacy and safety of passive immunotherapy by administering an equine hyperimmune serum (INM005) against the SARS-CoV-2 receptor binding domain (RBD) to COVID-19 patients. Improvement of the clinical course 28 days after the start of treatment will be evaluated.
Official title: A Phase 2/3, Adaptive, Randomized, Controlled, Double-blind Study to Investigate the Pharmacokinetics, Efficacy and Safety of the Hyperimmune Equine Serum (INM005) in Adult Patients With Moderate to Severe Confirmed SARS-CoV-2 Disease.
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
243
Start Date
2020-07-27
Completion Date
2020-12-30
Last Updated
2026-04-20
Healthy Volunteers
No
Conditions
Interventions
INM005
The investigational medicinal product (IMP) dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
Placebo
Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
Locations (19)
Hospital de Cuenca Alta
Canuelas, Buenos Aires, Argentina
Hospital Prof. Dr. Bernardo A. Houssay
Florida, Buenos Aires, Argentina
Instituto Medico Platense
La Plata, Buenos Aires, Argentina
Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina
Hospital Municipal Emilio Zerboni
San Antonio de Areco, Buenos Aires, Argentina
Hospital Alta Complejidad "El Cruce" Dr. Néstor Carlos Kirchner
San Juan Bautista, Buenos Aires, Argentina
Hospital Municipal Dr. Diego E. Thompson
San Martín, Buenos Aires, Argentina
Hospital Provincial Neuquén "Dr. Eduardo Castro Rendón"
Neuquén, Neuquén Province, Argentina
Hospital Centro de Salud Zenón J. Santillán
San Miguel de Tucumán, Tucumán Province, Argentina
Sanatorio Guemes
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Hospital Muñiz
Buenos Aires, Argentina
Hospital Pirovano
Buenos Aires, Argentina
Centro Gallego de Buenos Aires
Ciudad Autonoma de Buenos Aire, Argentina
Clínica Adventista Belgrano
Ciudad Autonoma de Buenos Aire, Argentina
Clínica Zabala
Ciudad Autonoma de Buenos Aire, Argentina
Hospital Español de Buenos Aires
Ciudad Autonoma de Buenos Aire, Argentina
Sanatorio Agote
Ciudad Autonoma de Buenos Aire, Argentina
Sanatorio Sagrado Corazón
Ciudad Autonoma de Buenos Aire, Argentina