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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT04582318
Eligibility Criteria:
Inclusion Criteria:
* Female subjects of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result prior to dosing.
* Female subjects of childbearing potential and male subjects with a female partner of childbearing potential must use an effective method of contraception during the study, for at least 1 month following study completion, and must not plan to become pregnant for at least 1 month after her last study medication dose.
* BMI 18-32 kg/m2 inclusive
* Ability to understand and provide informed consent
* Subjects confirmed with SARS-CoV-2 infection by PCR and hospitalized
* If on mechanical support, less or equal than 2 days on mechanical ventilation or oxygenation
Exclusion Criteria:
* Currently enrolled in another investigational protocol to treat SARS-CoV-2 infection
* Known history of complement deficiency
* Active infection with, or history of, compllicated pneumococcal or Neisseria meningitis infection or history of unexplained, recurrent infection, within the last 60 days prior to dosing.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04582318
Study Brief:
Protocol Section:
NCT04582318