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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT04355494
Eligibility Criteria:
Inclusion Criteria:
1. Males or females ≥ 18 years of age and ≥ 40 kg at the time of providing informed consent.
2. Confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization
3. Symptomatic, bilateral pulmonary infiltrates confirmed by CT or X-ray at Screening or within the 7 days prior to Screening
4. Severe pneumonia, acute lung injury, or ARDS requiring oxygen supplementation
Exclusion Criteria:
1. Confirmed diagnosis of SARS-CoV-2 infection presenting as mild to moderate COVID-19, even if the participant is hospitalized
2. Participant is not expected to survive more than 24 hours
3. Participant has an unresolved Neisseria meningitidis infection
4. Hypersensitivity to murine proteins or to one of the excipients of Soliris
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04355494
Study Brief:
Protocol Section:
NCT04355494