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Status:

UNKNOWN

A Proof-of-Concept Study Evaluating EOM613 in COVID-19 Infected Patients With Severe Symptoms

Lead Sponsor:

EOM Pharmaceuticals

Conditions:

COVID-19 Pneumonia

COVID-19 Respiratory Infection

Eligibility:

All Genders

18-84 years

Phase:

PHASE1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of EOM613, a peptide nucleic acid with novel immune-modulating properties, in treating patients with severe C...

Detailed Description

Much of the morbidity and mortality in COVID-19 infection is thought to be the result of an overly zealous attack by the immune system (e.g., cytokine storm and IL-6 elevations) as it attempts to coun...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Non-ICU cohort:
  • Males or females ≥18 years and \< 85 years of age
  • Positive test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS- CoV-2) by nasopharyngeal sampling using a reliable nucleic acid Reverse Transcription-Polymerase Chain Reaction (RT-PCR) assay or fast serological tests confirmed by RT PCR afterward
  • Hospitalized for Acute Respiratory Distress Syndrome (ARDS) or pneumonia
  • Requires oxygen therapy by nasal catheter or mask, but not invasive mechanical ventilation at the enrollment
  • ICU cohort:
  • Males or females ≥18 years and \< 85 years of age
  • Positive test for SARS-CoV-2 by nasopharyngeal sampling using a reliable nucleic acid RT-PCR assay
  • Hospitalized for ARDS or pneumonia and requires invasive mechanical ventilation at enrollment
  • Both cohorts:
  • Participant or suitable proxy able to provide written informed consent before study procedures are performed
  • Able to adhere to the study schedule and other protocol requirements
  • No known contraindications for administering EOM613, including Mycobacterium tuberculosis infection (assessed by the anamnesis) or receiving immunosuppressant therapy after transplant
  • Not enrolled in another study of an investigational agent during this study
  • Patients who developed complications of COVID-19 (such as myocardial disease, kidney dysfunction, clotting disorder, encephalitis, severe fatigue, or multi-immune inflammatory syndrome) are eligible
  • Exclusion Criteria
  • Both cohorts:
  • Active participation in any other clinical trial of an experimental treatment for COVID-19
  • Participation in another clinical trial with any investigational new drug within 12 months before enrollment, except if there is a possible benefit to the participant in the investigator's opinion (According to the Brazilian Resolution CNS 251/97 II.2-J)
  • Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 is prohibited \<24 hours before study medication initiation
  • Sequential Organ Failure Assessment Score \>10
  • Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated Glomerular Filtration Rate \[eGFR\] \<30)
  • Active cancer receiving any therapeutic intervention or under palliative care
  • Both cohorts, conditions existing before COVID-19:
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Heart failure or cardiomyopathies
  • Sickle cell disease
  • Solid-organ transplantation
  • Uncontrolled or poorly controlled Type 2 diabetes mellitus
  • Immunodeficiency or immunosuppressive therapy
  • Pregnant or breastfeeding
  • Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment
  • Known active Mycobacterium tuberculosis infection (assessed by the anamnesis)
  • Patients who are unwilling or unable to follow protocol requirements
  • Patients with body mass index (BMI) \< 18 kg/m2 or \> 40 kg/m2

Exclusion

    Key Trial Info

    Start Date :

    August 9 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 30 2022

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT05212532

    Start Date

    August 9 2021

    End Date

    March 30 2022

    Last Update

    January 28 2022

    Active Locations (4)

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    Page 1 of 1 (4 locations)

    1

    Oswaldo Cruz

    Manguinhos, Rio de Janeiro, Brazil, 21040-900

    2

    Hospital de Amor

    Barretos, São Paulo, Brazil, 14784-400

    3

    Hospital Municipal de Barueri

    Barueri, São Paulo, Brazil

    4

    Casa De Saúde

    Boqueirão, São Paulo, Brazil