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COMPLETED
NCT04494984
PHASE2/PHASE3

A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19.

Sponsor: Inmunova S.A.

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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