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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT04514302
Eligibility Criteria:
Key Inclusion criteria
* Outpatient with a RT-qPCR confirmation of SARS-CoV-2 infection
* Body Mass Index (BMI) at screening of 18.0 - 34.9 kg/m\^2
* Presence of at least one symptom consistent with COVID-19
* Mild illness as defined by no requirement of supplementary oxygen or hospitalization criteria are met
Key Exclusion criteria
* Presence of a risk factor for disease progression documented for COVID-19 such as: uncontrolled diabetes, uncontrolled hypertension, cardiovascular disease, pulmonary disease, COPD, asthma, active cancer, immunosuppression, hypercoagulable states, CKD currently under dialysis
* Documented allergy to equine serum proteins
* Previous hospitalization due to COVID-19
* Supplementary oxygen, invasive ventilation, or mechanical circulatory support requirements
* Having received convalescent plasma or intravenous immunoglobulins for the treatment of COVID-19
* Previous vaccination or plans to get vaccinated for COVID-19
* In the opinion of investigator, other health conditions that suppose an increased risk of progression of disease
NOTE: Other inclusion/exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04514302
Study Brief:
Protocol Section:
NCT04514302