SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19

Study Overview
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Brief Summary
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This protocol provides access to eculizumab treatment for participants with severe COVID-19.

Detailed Description
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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.

Official Title
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SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID 19) - An Expanded Access Program for Hospital-based Emergency Treatment

Conditions
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COVID-19, Pneumonia, Viral, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Intervention / Treatment
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* Biological: eculizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: eculizumab|Eculizumab at doses of 900-1200 mg will be administered intravenously (up to 7 doses)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eculizumab, acute lung injury, acute respiratory distress syndrome, antibodies, monoclonal, humanized, complement inhibition, COVID-19, emergency treatment, expanded access program, hospitalization, pneumonia, severe acute respiratory syndrome, severe acute respiratory syndrome coronavirus 2, severe pneumonia, Soliris, viral