This protocol provides access to eculizumab treatment for participants with severe COVID-19.
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 pneumonia, acute lung injury, or ARDS to be treated with eculizumab. Participants admitted to a designated hospital facility who qualify for emergency treatment will be administered eculizumab up to 7 times during their treatment course (5 mandatory doses and up to 2 optional doses, per Investigator assessment). The EAP consists of a Screening Period of up to 7 days, a 4-week Treatment Period, a final in-hospital assessment on Day 29 or day of discharge, whichever occurs first, and 3 monthly safety follow up visits (to be conducted as a telephone call if the participant has been discharged from the hospital or an in-person visit if the participant is still hospitalized). For each participant, the total duration of the program is anticipated to be 4.5 months.
Eculizumab at doses of 900-1200 mg will be administered intravenously (up to 7 doses)
Other Name: Soliris
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
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Boston Medical Center
Boston, Massachusetts, 02118
Newton, Massachusetts, 02462
Rochester, Minnesota, 55905
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Alexion Pharmaceuticals Inc.