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Completed

NCT Number: NCT04494984

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital de Cuenca Alta, Canuelas, Buenos Aires, Argentina

Loading trial locations.

About this study

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-CoV-2 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-CoV-2 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects of both sexes aged 18 to 79 years of age
  • SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) for virus detection
  • Patients with moderate or severe disease by NIH definition, which requires hospitalization.
  • Acceptance to participate in the study by the signature of the informed consent by a subject or their relative, if applicable
  • 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
  • Female patients of child-bearing age with negative pregnancy test

Exclusion criteria

  • Patients who have received treatment with plasma from COVID-19 convalescents.
  • Patients who are participating in other therapeutic clinical trials
  • Patients who require mechanical respiratory assistance or are hospitalized in the ICU at the time of the screening visit.
  • 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.
  • Pregnant or breastfeeding women
  • 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
  • Patients who are expected to be referred to another institution within 72 hours of enrollment, which prevents proper follow-up of that patient.

Treatment and study plan

INM005

Drug

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.

Other names: COVIFAB

Placebo

Drug

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.

Primary outcomes

  1. Number of Participants With Improvement in at Least Two Categories in WHO 8-point Ordinal Clinical Scale at Day 28 or Discharge

    Time frame: Discharge or up to Day 28

    The primary endpoint will be the proportion of patients who showed improvement 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.

    The ordinal scale measures illness severity over time, the minimum value is 0 and the maximum value is 8. The higher is the score, the worse is the outcome. Detailed scale:

    0 = no evidence of infection,

    • = outpatient, with no activities limitation;
    • = outpatient, with activities limitation;
    • = hospitalised with no oxygen therapy required;
    • = oxygen therapy employing a mask;
    • = non-invasive ventilation or high flow oxygen;
    • = Mechanical ventilation;
    • = mechanical ventilation and organ support (vasopressors, extracorporeal membrane oxygenation (ECMO), renal replacement therapy (RRT);
    • = Death

Secondary outcomes

  1. Pharmacokinetics (PK) Evaluation of INM005 (Cmax)

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

    INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:

    • Cmax after (mg/L) Dose 1
    • Cmax (mg/L) after Dose 2

  2. Pharmacokinetics (PK) Evaluation of INM005 (Clearance)

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

    INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:

    • Clearance (mL/h) after Dose 1

  3. Pharmacokinetics (PK) Evaluation of INM005 (Weight-adjusted Clearance)

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

    INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:

    • Weight-adjusted Clearance (mL/h/kg) after Dose 1

  4. Pharmacokinetics (PK) Evaluation of INM005 (AUC0)

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

    INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:

    • AUC0-t (mg/L*h) after Dose 1
    • AUC0-I (mg/L*h) after Dose 1
    • AUC0-I (mg/L*h) -Normalized- after Dose 1
    • AUC0-t (mg/L*h) after Dose 2
    • AUC0-I (mg/L*h) after Dose 2
    • AUC0-I (mg/L*h) -Normalized- after Dose 2

  5. Pharmacokinetics (PK) Evaluation of INM005 (Elimination Half-time)

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

    INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:

    • Elimination half-time (hs) after Dose 1
    • Elimination half-time (hs) after Dose 2
    • Mean Residence Time (hs) after Dose 1

  6. Pharmacokinetics (PK) Evaluation of INM005 (Elimination Rate)

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

    INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:

    • Elimination rate after Dose 1
    • Elimination rate after Dose 2

  7. Pharmacokinetics (PK) Evaluation of INM005 (Distribution Volume)

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

    INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:

    • Distribution Volume (L) after Dose 1

  8. Pharmacokinetics (PK) Evaluation of INM005 (Weight-adjusted Distribution Volumen)

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose

    INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured:

    • Weight-adjusted Distribution volumen (L/kg) after Dose 1

  9. Time to Progression of Disease

    Time frame: 28 days

    Time to achieve decrease 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).

  10. Clinical Improvement at Day 7 and Day 14

    Time frame: up to 2 weeks

    Percentage of patients who present a decrease 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.

  11. Patients Discharged at 28 Days

    Time frame: up to 4 weeks

    Rate of discharged patients at 28 days

  12. Participants Who Require (ICU) Hospitalization

    Time frame: up to 4 weeks

    Cumulative percentage of patients who require Intensive care unit (ICU) hospitalization

  13. Participants Who Require Mechanical Ventilation Assistance (MVA)

    Time frame: up to 4 weeks

    Rate of participants who require Mechanical ventilation assistance

  14. Mortality at Day 28

    Time frame: up to 4 weeks

    Mortality rate due to complications from COVID-19 at day 28

  15. Changes in Viral Load

    Time frame: up to 3 weeks

    Percentage of participants with detectable viral load at baseline, day 7 and day 21 after the start of the treatment..

    GeneFinder ™ COVID-19 PLUS RealAmp Kit was used for detection of COVID-19 virus through reverse Transcription and Real-Time Polymerase Chain Reaction from RNA extracted from Respiratory specimens such as throat swab.

    This product can qualitatively detect COVID-19 using One-Step Reverse Transcription Real-Time polymerase chain reaction to confirm the presence of SARS-COV-2 by amplification of the genes RdRp (RNA-dependent RNA polymerase), E (Envelope) and N (Nucleocapsid).

Other outcomes

  1. Anti SARS-CoV-2 Antibodies Levels

    Time frame: 3 weeks

    Measurement of anti SARS-CoV-2 antibodies titer levels. Immunoglobulin G (IgG) at 0, 7, 21 days

  2. Changes in Troponin T Levels

    Time frame: 3 weeks

    Changes in Troponin T levels will be evaluated at baseline, day 7 and day 21 as a measurement of disease progression

  3. Changes in D-dimer Levels

    Time frame: 3 weeks

    Changes in D-dimer levels will be evaluated at Baseline, day 7 and day 21 as a measurement of disease progression

  4. Changes in Ferritin Levels

    Time frame: 3 weeks

    Changes in Ferritin levels will be evaluated at baseline, day 7 and day 21 as a measurement of disease progression

  5. Changes in Lactate Dehydrogenase (LDH) Levels

    Time frame: 3 weeks

    Changes in LDH levels will be evaluated at baseline, day 2, day 4 and day 21 as a measurement of disease progression

  6. Changes in C-reactive Protein Levels

    Time frame: 3 weeks

    Changes in C-reactive protein levels will be evaluated at baseline, day 7, and day 21 as a measurement of disease progression

  7. Measurement of Anti-INM005 Antibodies

    Time frame: 3 weeks

    Measurement of anti-INM005 antibodies: baseline and 21 days

Sponsors and collaborators

Lead sponsor

Inmunova S.A.

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2020
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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