This study aims to analyze the efficacy and safety of passive immunotherapy by administering an equine hyperimmune serum (INM005) against the SARS-CoV2 RBD to Covid19 patients. Improvement of the clinical course 28 days after the start of treatment will be evaluated.
The pandemic caused by the new coronavirus has generated a situation unprecedented in recent
history, with several million infected and hundreds of thousands of deaths. This disease is
easily transmissible by air. Although a high percentage of cases present mild clinical
presentation, approximately 15% of patients present moderate to severe cases and 5% require
critical care, with respiratory assistance and a high risk of mortality. No effective
therapies for the treatment or prevention of SARS.CoV2 have been identified yet. Preliminary
evidence indicates that passive immunotherapy with convalescent plasma could alter the
clinical course of this infection in a favorable manner. This strategy, even if confirmed as
successful, requires voluntary donation by patients who have recovered, not all of whom are
eligible as donors, since the antibody response varies in magnitude in different patients.
This adaptive stage II/III study aims to analyze the efficacy and safety of passive
immunotherapy by administering a purified Fab fraction of equine hyperimmune serum (INM005)
generated from antigenic stimulation with the SARS-CoV2 RBD protein, with the objective of
neutralizing the interaction of SARS-CoV-2 with its cellular receptor, thus preventing the
multiplication of the virus. The safety of this type of equine hyperimmune sera has already
been demonstrated in previous and ongoing protocols with a biologically equivalent product
against the E. Coli shiga toxin to treat patients with Hemolytic Uremic Syndrome
(CT-INM004-01 and CT-INM004-02). In the present study, eligible patients will with moderate
to severe symptoms of COVID-19 that require hospitalization will receive two 4 mg/kg doses of
INM005, two days apart, with the aim of improving the clinical course of COVID-19 28 days
after the start of treatment with the study drug.
Drug: INM005
The 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.
Inclusion Criteria:
1. Subjects of both sexes aged 18 to 79 years of age
2. SARS-CoV-2 infection confirmed by 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.
Hospital de Cuenca Alta
Cañuelas, Buenos Aires, Argentina
Hospital Alta Complejidad "El Cruce" Dr. Néstor Carlos Kirchner
Florencio Varela, 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 Municipal Dr. Diego E. Thompson
San Martín, Buenos Aires, Argentina
Hospital Pablo Soria
San Salvador De Jujuy, Jujuy, Argentina
Hospital Provincial Neuquén "Dr. Eduardo Castro Rendón"
Neuquén, Neuquen, Argentina
Hospital Centro de Salud Zenón J. Santillán
San Miguel De Tucumán, Tucuman, Argentina
Sanatorio Guemes
Ciudad Autonoma de Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Argentina
Hospital Muñiz
Ciudad Autonoma de Buenos Aires, Argentina
Hospital Pirovano
Ciudad Autonoma de Buenos Aires, Argentina
Centro Gallego de Buenos Aires
Ciudad Autonoma de Buenos Aire, Argentina
Clínica Adventista Belgrano
Ciudad Autonoma de Buenos Aire, Argentina
Clínica Pasteleros
Ciudad Autonoma de Buenos Aire, Argentina
Clínica Zabala
Ciudad Autonoma de Buenos Aire, Argentina
Fundación Favaloro
Ciudad Autonoma de Buenos Aire, Argentina
Hospital Español de Buenos Aires
Ciudad Autonoma de Buenos Aire, Argentina
Hospital G. A. Carlos G. Durand
Ciudad Autonoma de Buenos Aire, Argentina
Sanatorio Agote
Ciudad Autonoma de Buenos Aire, Argentina
Sanatorio Sagrado Corazón
Ciudad Autonoma de Buenos Aire, Argentina
Santiago Sanguineti, Ph.D., Study Director
Inmunova S.A.