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

• Status: Recruiting
• Trial end date: 2022-03-30
• Target enrollment: 0
• Participant gender: All

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 COVID-19 infections. This proof-of-concept study is the first clinical trial of EOM613 in this patient population.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EOM Pharmaceuticals

Criteria

1. Inclusion Criteria

1. 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

2. 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

3. 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

2. Exclusion Criteria

1. 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

2. 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