Status:
NO_LONGER_AVAILABLE
COVID-19 Soliris Expanded Access Protocol
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Covid19
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- Males or females ≥ 18 years of age and body weight ≥ 40 kg.
- 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).
- 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.
- 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
- Unresolved Neisseria meningitidis infection.
- Known hypersensitivity to murine proteins or to an excipient of Soliris.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04802083
Last Update
October 4 2021
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