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:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT04701658
Eligibility Criteria:
Inclusion Criteria:
* Are currently not hospitalized.
* Have one or more mild or moderate COVID-19 symptoms.
* Must have first positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral infection determination and as soon as possible within 10 days of symptom onset
* Are males or non-breastfeeding females.
* Contraceptive use by males or females should be consistent with local regulations for those participating in clinical studies.
* Are at high risk for progressing to severe COVID-19 and/or hospitalization.
Exclusion Criteria:
* Participants who:
* are hospitalized due to COVID-19, OR
* require oxygen therapy due to COVID-19, OR
* require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
* Have peripheral capillary oxygen saturation (SpO2) less than or equal to (≤) 90 percent on room air or arterial partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) less than (\<) 300, respiratory rate greater than or equal to (≥) 30 per minute, heart rate ≥125 per minute.
* Have body weight \<40 kilograms.
* Require mechanical ventilation or anticipated impending need for mechanical ventilation.
* Have known allergies to any of the components used in the formulation of the interventions.
* Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention.
* Have any comorbidity requiring surgery within \<7 days, or that is considered life-threatening within 29 days.
* Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
* Have a history of a positive SARS-CoV-2 serology test.
* Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study.
* Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing.
* Have received treatment with a SARS-CoV-2-specific monoclonal antibody, remdesivir, or other treatment for COVID-19.
* Have received convalescent COVID-19 plasma treatment.
* Have participated in a previous SARS-CoV-2 vaccine study.
* Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
* Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
* Are breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT04701658
Study Brief:
Protocol Section:
NCT04701658