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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT05226533
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years at time of signing the Informed Consent Form (ICF).
* SARS-CoV-2 infection documented by RT-PCR within 7 days prior to randomization.
* Hospitalized patients who meet the criteria of moderate or severe COVID-19.
* Patients who are not pregnant, based on urine pregnancy test during screening, and randomization.
* Female patients of childbearing potential practice effective contraception during the study and be willing and able to continue contraception for 60 days after their dose of study treatment.
* Male patient and/or Female patient's partner agree to use condoms or should have undergone vasectomy or spermicide in addition to female contraception for additional protection against conception for 60 days after their dose of study treatment.
* Patients who are anticipated to available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff.
* Patients who agree to give written informed consent and are willing to participate in the study.
Exclusion Criteria:
* Patients with BMI ≥30 and/or body weight \< 40kg
* Patients receiving or who have received antiviral therapy and antiretroviral therapy within 28 days prior to the screening visit.
* Patients who cannot be administered intramuscularly to bilateral ventro-gluteal area.
* Patients with uncontrolled respiratory disease other than COVID-19 pneumonia (i.e. COPD, asthma, cystic fibrosis, etc.)
* Patients who have active malignancy, history of active malignancy or chemotherapy within 1 year from the screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05226533
Study Brief:
Protocol Section:
NCT05226533