Status:
NO_LONGER_AVAILABLE
SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
COVID-19
Pneumonia, Viral
Eligibility:
All Genders
18+ years
Brief Summary
This protocol provides access to eculizumab treatment for participants with severe COVID-19.
Detailed Description
This is an open label, multicenter, Expanded Access Program (EAP) to allow participants with a confirmed diagnosis of SARS-CoV-2 infection, and a clinical presentation consistent with COVID-19 severe ...
Eligibility Criteria
Inclusion
- Males or females ≥ 18 years of age and ≥ 40 kg at the time of providing informed consent.
- Confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization
- Symptomatic, bilateral pulmonary infiltrates confirmed by CT or X-ray at Screening or within the 7 days prior to Screening
- Severe pneumonia, acute lung injury, or ARDS requiring oxygen supplementation
Exclusion
- Confirmed diagnosis of SARS-CoV-2 infection presenting as mild to moderate COVID-19, even if the participant is hospitalized
- Participant is not expected to survive more than 24 hours
- Participant has an unresolved Neisseria meningitidis infection
- Hypersensitivity to murine proteins or to one of the excipients of Soliris
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04355494
Last Update
March 9 2021
Active Locations (12)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Boston Medical Center
Boston, Massachusetts, United States, 02118
3
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
4
Mayo Clinic
Rochester, Minnesota, United States, 55905