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

CompletedPhase 2, Phase 3

Sponsor: Inmunova S.A.

Conditions: COVID-19

Interventions: INM005, Placebo

Countries: Argentina

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 79 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Subjects of both sexes aged 18 to 79 years of age
2. SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) for virus detection
3. Patients with moderate or severe disease by NIH definition, which requires hospitalization.
4. Acceptance to participate in the study by the signature of the informed consent by a subject or their relative, if applicable
5. Be within 10 days of the onset of symptoms at the time of the Screening visit according to a case definition from the National Ministry of Health
6. Female patients of child-bearing age with negative pregnancy test

Exclusion Criteria:

1. Patients who have received treatment with plasma from COVID-19 convalescents.
2. Patients who are participating in other therapeutic clinical trials
3. Patients who require mechanical respiratory assistance or are hospitalized in the ICU at the time of the screening visit.
4. History of anaphylaxis, prior administration of equine serum (por example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) or allergic reaction due to contact or exposure to horses.
5. Pregnant or breastfeeding women
6. Patients who, at the doctor's discretion, are likely to die within the next 30 days due to a concomitant disease other than the study disease
7. Patients who are expected to be referred to another institution within 72 hours of enrollment, which prevents proper follow-up of that patient.

Locations (19)

Canuelas, Buenos Aires, Argentina
Florida, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
San Antonio de Areco, Buenos Aires, Argentina
San Juan Bautista, Buenos Aires, Argentina
San Martín, Buenos Aires, Argentina
Neuquén, Neuquén Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Ciudad Autonoma de Buenos Aire, Argentina
Ciudad Autonoma de Buenos Aire, Argentina
Ciudad Autonoma de Buenos Aire, Argentina
Ciudad Autonoma de Buenos Aire, Argentina
Ciudad Autonoma de Buenos Aire, Argentina
Ciudad Autonoma de Buenos Aire, Argentina