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 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT05205759
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 50 years
* Informed consent by the subject or legally authorized representative
* Laboratory-confirmed SARS-CoV-2 infection, as determined by antigen or nucleic acid identification in any specimen, within 4 days of eligibility assessment
* Peripheral oxygen saturation ≥ 94% on room air and not requiring supplemental oxygen
* Onset of symptoms within 4 days of eligibility assessment. Onset time of symptoms is defined as the time when the patient experienced the presence of at least one of the following SARS-CoV-2 infection-associated symptoms for the first time \[4\]: cough, nasal congestion, sore throat, feeling hot or feverish, myalgia, fatigue, headache, anosmia/ageusia, nausea, vomiting, and/or diarrhoea
Exclusion Criteria:
* Previously or currently hospitalized or requiring hospitalization
* Respiratory distress with respiratory rate ≥ 25 breaths/min
* Heart rate ≥ 125 beats per minute
* Peripheral oxygen saturation ≤ 93% on room air at sea level
* Known allergies to any of the components used in the formulation of the trial drugs
* Hemodynamic instability requiring use of pressors within 24 hours of randomization
* Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that could potentially lead to hospitalization within 30 days
* Any co-morbidity requiring surgery within 7 days or that is considered life-threatening within 90 days
* History of positive SARS-CoV-2 test prior to 4 days of the eligibility assessment
* Previous treatment with a SARS-CoV-2 specific monoclonal antibody
* History of convalescent COVID-19 plasma treatment
* Participation in a clinical study involving an investigational intervention within the last 30 days
* Pregnancy or breast feeding
* Investigator site personnel directly affiliated with this study
* Sexually active women of childbearing potential or sexually active men who are unwilling to practice effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose
* Inability to participate to the study follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT05205759
Study Brief:
Protocol Section:
NCT05205759