Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), COVID-19, Pneumonia, Viral
Conditions
Keywords
acute lung injury, acute respiratory distress syndrome, antibodies, monoclonal, humanized, complement inhibition, COVID-19, eculizumab, emergency treatment, expanded access program, hospitalization, pneumonia, severe acute respiratory syndrome, severe acute respiratory syndrome coronavirus 2, severe pneumonia, Soliris, viral
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 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.
Interventions
BIOLOGICALeculizumab
Eculizumab at doses of 900-1200 mg will be administered intravenously (up to 7 doses)
Sponsors
Alexion Pharmaceuticals, Inc.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Countries
France, United States
Outcome results
None listed