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.
Biological: eculizumab
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, United States
Boston Medical Center
Boston, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Hôpital Henri Mondor
Creteil, France
Hôpital Garches Raymond Poincaré
Garches, France
Hôpital de Bicêtre
Le Kremlin Bicêtre, France
Hôpital Saint Louis
Paris, France
Hôpital Paul Brousse
Villejuif, France