Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT05212532
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
84 Years
Study:
NCT05212532
Study Brief:
Protocol Section:
NCT05212532