<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04494984</url>
  </required_header>
  <id_info>
    <org_study_id>CT-INM005-01</org_study_id>
    <nct_id>NCT04494984</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19.</brief_title>
  <official_title>A Stage 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-CoV2 Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inmunova S.A.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inmunova S.A.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to analyze the efficacy and safety of passive immunotherapy by administering&#xD;
      an equine hyperimmune serum (INM005) against the SARS-CoV2 RBD to Covid19 patients.&#xD;
      Improvement of the clinical course 28 days after the start of treatment will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pandemic caused by the new coronavirus has generated a situation unprecedented in recent&#xD;
      history, with several million infected and hundreds of thousands of deaths. This disease is&#xD;
      easily transmissible by air. Although a high percentage of cases present mild clinical&#xD;
      presentation, approximately 15% of patients present moderate to severe cases and 5% require&#xD;
      critical care, with respiratory assistance and a high risk of mortality. No effective&#xD;
      therapies for the treatment or prevention of SARS.CoV2 have been identified yet. Preliminary&#xD;
      evidence indicates that passive immunotherapy with convalescent plasma could alter the&#xD;
      clinical course of this infection in a favorable manner. This strategy, even if confirmed as&#xD;
      successful, requires voluntary donation by patients who have recovered, not all of whom are&#xD;
      eligible as donors, since the antibody response varies in magnitude in different patients.&#xD;
      This adaptive stage II/III study aims to analyze the efficacy and safety of passive&#xD;
      immunotherapy by administering a purified Fab fraction of equine hyperimmune serum (INM005)&#xD;
      generated from antigenic stimulation with the SARS-CoV2 RBD protein, with the objective of&#xD;
      neutralizing the interaction of SARS-CoV-2 with its cellular receptor, thus preventing the&#xD;
      multiplication of the virus. The safety of this type of equine hyperimmune sera has already&#xD;
      been demonstrated in previous and ongoing protocols with a biologically equivalent product&#xD;
      against the E. Coli shiga toxin to treat patients with Hemolytic Uremic Syndrome&#xD;
      (CT-INM004-01 and CT-INM004-02). In the present study, eligible patients will with moderate&#xD;
      to severe symptoms of COVID-19 that require hospitalization will receive two 4 mg/kg doses of&#xD;
      INM005, two days apart, with the aim of improving the clinical course of COVID-19 28 days&#xD;
      after the start of treatment with the study drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 23, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>This study will be an adaptive phase 2/3 investigation. First, 12 subjects will be randomly assigned to receive 1 of the 2 treatment regimens (study drug or placebo) in a 1:1 ratio. After the first 6 subjects have been enrolled and have completed 24 hours post treatment of 2nd dose, the IDMC will review the safety data and will inform whether to continue with staggered enrollment. Randomization ratio for subjects in the following stage will be 1:1. The independent data monitoring committee (IDMC) will review safety data after 12, 24, 48 and 96 patients have been enrolled in each arm. The study will then enroll a total of 121 patients in each arm. An interim analysis will be performed after 80% of recruitment has been reached (n=194). The IDMC will analyze the rate of events in the group under &quot;standard of care&quot;.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>A Double-blind, Placebo-controlled, sealed-envelope based. Access to unblinded interim results will be limited to the DMC and unblinded statistician</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical changes in COVID-19 symptoms</measure>
    <time_frame>4 weeks</time_frame>
    <description>The primary endpoint will be the proportion of patients who show a change in symptoms 28 days after the administration of the first dose. A responding subject is defined as a subject with improvement in at least 2 categories on the 8-point World Health Organization (WHO) ordinal scale of clinical status or a subject who is discharged.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics evaluation of INM005</measure>
    <time_frame>1 week</time_frame>
    <description>INM005 product concentration in serum at different time points after dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression of disease</measure>
    <time_frame>4 weeks</time_frame>
    <description>Time to achieve a change in at least 2 categories on the 8-point WHO ordinal scale of clinical status.&#xD;
Time to discharge (days). Time to intensive care unit (ICU) discharge (days).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease progression</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>Proportion of patients who present change in at least 2 categories on the 8-point WHO ordinal scale of clinical status at 7 and 14 days after the start of the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>Proportion of patients discharged at 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive care unit (ICU) hospitalization</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>Proportion of patients who require ICU hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation assistance (MVA)</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>Proportion of patients who require MVA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>Proportion of patients who die due to complications from COVID19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in viral load</measure>
    <time_frame>up to 3 weeks</time_frame>
    <description>Change in viral load from baseline to 7 and 21 days after the start of the treatment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Anti SARS-CoV2 antibodies levels</measure>
    <time_frame>3 weeks</time_frame>
    <description>Measurement of anti SARS-CoV2 antibodies titer levels. IgG (0, 21 days)</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Troponin T levels</measure>
    <time_frame>3 weeks</time_frame>
    <description>Changes in Troponin T levels will be evaluated at 7 and 21 days as a measurement of disease progression</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in D-dimer levels</measure>
    <time_frame>3 weeks</time_frame>
    <description>Changes in D-dimer levels will be evaluated at 7 and 21 days as a measurement of disease progression</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Ferritin levels</measure>
    <time_frame>3 weeks</time_frame>
    <description>Changes in Ferritin levels will be evaluated at 7 and 21 days as a measurement of disease progression</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in LDH levels</measure>
    <time_frame>3 weeks</time_frame>
    <description>Changes in LDH levels will be evaluated at 7 and 21 days as a measurement of disease progression</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in C-reactive protein levels</measure>
    <time_frame>3 weeks</time_frame>
    <description>Changes in C-reactive protein levels will be evaluated at 7 and 21 days as a measurement of disease progression</description>
  </other_outcome>
  <other_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>3 weeks</time_frame>
    <description>Measurement of anti-INM005 antibodies: baseline and 21 days</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">242</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F[ab']2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INM005</intervention_name>
    <description>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.</description>
    <arm_group_label>Active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>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.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects of both sexes aged 18 to 79 years of age&#xD;
&#xD;
          2. SARS-CoV-2 infection confirmed by PCR for virus detection&#xD;
&#xD;
          3. Patients with moderate or severe disease by NIH definition, which requires&#xD;
             hospitalization.&#xD;
&#xD;
          4. Acceptance to participate in the study by the signature of the informed consent by a&#xD;
             subject or their relative, if applicable&#xD;
&#xD;
          5. Be within 10 days of the onset of symptoms at the time of the Screening visit&#xD;
             according to a case definition from the National Ministry of Health&#xD;
&#xD;
          6. Female patients of child-bearing age with negative pregnancy test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have received treatment with plasma from COVID-19 convalescents.&#xD;
&#xD;
          2. Patients who are participating in other therapeutic clinical trials&#xD;
&#xD;
          3. Patients who require mechanical respiratory assistance or are hospitalized in the ICU&#xD;
             at the time of the screening visit.&#xD;
&#xD;
          4. History of anaphylaxis, prior administration of equine serum (por example,&#xD;
             anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) or allergic&#xD;
             reaction due to contact or exposure to horses.&#xD;
&#xD;
          5. Pregnant or breastfeeding women&#xD;
&#xD;
          6. Patients who, at the doctor's discretion, are likely to die within the next 30 days&#xD;
             due to a concomitant disease other than the study disease&#xD;
&#xD;
          7. Patients who are expected to be referred to another institution within 72 hours of&#xD;
             enrollment, which prevents proper follow-up of that patient.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Santiago Sanguineti, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Inmunova S.A.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Cuenca Alta</name>
      <address>
        <city>Cañuelas</city>
        <state>Buenos Aires</state>
        <zip>B1814</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Alta Complejidad &quot;El Cruce&quot; Dr. Néstor Carlos Kirchner</name>
      <address>
        <city>Florencio Varela</city>
        <state>Buenos Aires</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Prof. Dr. Bernardo A. Houssay</name>
      <address>
        <city>Florida</city>
        <state>Buenos Aires</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Medico Platense</name>
      <address>
        <city>La Plata</city>
        <state>Buenos Aires</state>
        <zip>B1900AVG</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Italiano de La Plata</name>
      <address>
        <city>La Plata</city>
        <state>Buenos Aires</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Municipal Emilio Zerboni</name>
      <address>
        <city>San Antonio de Areco</city>
        <state>Buenos Aires</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Municipal Dr. Diego E. Thompson</name>
      <address>
        <city>San Martín</city>
        <state>Buenos Aires</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pablo Soria</name>
      <address>
        <city>San Salvador De Jujuy</city>
        <state>Jujuy</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Provincial Neuquén &quot;Dr. Eduardo Castro Rendón&quot;</name>
      <address>
        <city>Neuquén</city>
        <state>Neuquen</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Centro de Salud Zenón J. Santillán</name>
      <address>
        <city>San Miguel De Tucumán</city>
        <state>Tucuman</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Guemes</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <zip>C1180AAD</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Italiano de Buenos Aires</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <zip>C1199ABH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Muñiz</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <zip>C1282AEN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pirovano</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <zip>C1428</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Gallego de Buenos Aires</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Adventista Belgrano</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Pasteleros</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Zabala</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Favaloro</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Español de Buenos Aires</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital G. A. Carlos G. Durand</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Agote</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Sagrado Corazón</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 28, 2022</submitted>
    <returned>April 1, 2022</returned>
    <submitted>August 18, 2022</submitted>
    <returned>July 11, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04494984
org study id: CT-INM005-01
nct id: NCT04494984
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: This study will be an adaptive phase 2/3 investigation. First, 12 subjects will be randomly assigned to receive 1 of the 2 treatment regimens (study drug or placebo) in a 1:1 ratio. After the first 6 subjects have been enrolled and have completed 24 hours post treatment of 2nd dose, the IDMC will review the safety data and will inform whether to continue with staggered enrollment. Randomization ratio for subjects in the following stage will be 1:1. The independent data monitoring committee (IDMC) will review safety data after 12, 24, 48 and 96 patients have been enrolled in each arm. The study will then enroll a total of 121 patients in each arm. An interim analysis will be performed after 80% of recruitment has been reached (n=194). The IDMC will analyze the rate of events in the group under "standard of care".
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: A Double-blind, Placebo-controlled, sealed-envelope based. Access to unblinded interim results will be limited to the DMC and unblinded statistician
measure: Clinical changes in COVID-19 symptoms
time frame: 4 weeks
description: The primary endpoint will be the proportion of patients who show a change in symptoms 28 days after the administration of the first dose. A responding subject is defined as a subject with improvement in at least 2 categories on the 8-point World Health Organization (WHO) ordinal scale of clinical status or a subject who is discharged.
measure: Pharmacokinetics evaluation of INM005
time frame: 1 week
description: INM005 product concentration in serum at different time points after dosing
measure: Time to progression of disease
time frame: 4 weeks
description: Time to achieve a change in at least 2 categories on the 8-point WHO ordinal scale of clinical status.
Time to discharge (days). Time to intensive care unit (ICU) discharge (days).
measure: Disease progression
time frame: up to 2 weeks
description: Proportion of patients who present change in at least 2 categories on the 8-point WHO ordinal scale of clinical status at 7 and 14 days after the start of the treatment.
measure: Discharge
time frame: up to 4 weeks
description: Proportion of patients discharged at 28 days
measure: Intensive care unit (ICU) hospitalization
time frame: up to 4 weeks
description: Proportion of patients who require ICU hospitalization
measure: Mechanical ventilation assistance (MVA)
time frame: up to 4 weeks
description: Proportion of patients who require MVA
measure: Mortality
time frame: up to 4 weeks
description: Proportion of patients who die due to complications from COVID19
measure: Changes in viral load
time frame: up to 3 weeks
description: Change in viral load from baseline to 7 and 21 days after the start of the treatment.
measure: Anti SARS-CoV2 antibodies levels
time frame: 3 weeks
description: Measurement of anti SARS-CoV2 antibodies titer levels. IgG (0, 21 days)
measure: Changes in Troponin T levels
time frame: 3 weeks
description: Changes in Troponin T levels will be evaluated at 7 and 21 days as a measurement of disease progression
measure: Changes in D-dimer levels
time frame: 3 weeks
description: Changes in D-dimer levels will be evaluated at 7 and 21 days as a measurement of disease progression
measure: Changes in Ferritin levels
time frame: 3 weeks
description: Changes in Ferritin levels will be evaluated at 7 and 21 days as a measurement of disease progression
measure: Changes in LDH levels
time frame: 3 weeks
description: Changes in LDH levels will be evaluated at 7 and 21 days as a measurement of disease progression
measure: Changes in C-reactive protein levels
time frame: 3 weeks
description: Changes in C-reactive protein levels will be evaluated at 7 and 21 days as a measurement of disease progression
measure: Immunogenicity
time frame: 3 weeks
description: Measurement of anti-INM005 antibodies: baseline and 21 days
arm group label: Active
arm group type: Active Comparator
description: Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F[ab']2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
intervention type: Drug
intervention name: INM005
description: 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.
arm group label: Active
intervention type: Drug
intervention name: Placebo
description: 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.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Santiago Sanguineti, Ph.D.
role: Study Director
affiliation: Inmunova S.A.
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country: Argentina
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No
submitted: March 28, 2022
returned: April 1, 2022
submitted: August 18, 2022
returned: July 11, 2023