Official Title
SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID-19) - An Expanded Access Protocol
Brief Summary

This protocol provides participants with COVID-19 access to Soliris.

Detailed Description

This is an open-label, multicenter, expanded access protocol that will provide access to

Soliris for participants diagnosed with severe acute respiratory syndrome coronavirus 2

(SARS-COV-2) infection with a clinical presentation consistent with COVID-19 associated organ

injury, such as acute respiratory distress syndrome, stroke, or acute renal failure.

Participants who qualify for emergency treatment (whether in an inpatient or outpatient

setting) will be offered the opportunity to receive up to 7 infusions of Soliris over

approximately 4 weeks.

Available
Intermediate-size Population
COVID19

Biological: Eculizumab
Eculizumab 900-1200 mg will be administered intravenously.
Other Name: Soliris, monoclonal antibody

Eligibility Criteria

Inclusion Criteria: 1. Males or females ≥ 18 years of age and body weight ≥ 40 kg. 2. Confirmed diagnosis of SARS-COV-2 infection by any method used by the institution (eg, via reverse transcriptase polymerase chain reaction and/or antibody test). 3. Willing to receive vaccination against Neisseria meningitidis and prophylactic antibiotics against meningococcal infections if the participant has not been vaccinated within 5 years prior to Day 1. 4. In the opinion of the Investigator, the participant is suitable to be enrolled in the expanded access protocol (EAP), based on the participant's overall clinical condition and the known Soliris benefit/risk profile.

Exclusion Criteria: 1. Unresolved Neisseria meningitidis infection. 2. Known hypersensitivity to murine proteins or to an excipient of Soliris.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Contacts

Alexion Pharmaceuticals, Inc.
855-75202356
alexionaccess@alexion.com

Alexion Pharmaceuticals
NCT Number
Keywords
Soliris
Eculizumab
C5 inhibitor
Covid-19
SARS-CoV-2
Acute Lung Injury
severe pneumonia
Acute Respiratory Distress Syndrome
Severe acute respiratory syndrome coronavirus 2
Severe acute respiratory syndrome
Multi-organ injury
hospitalization
Antibodies
Monoclonal
humanized
emergency treatment
Viral
Expanded Access
MeSH Terms
Antibodies, Monoclonal
Intervention Name
Eculizumab