COVID-19 Soliris Expanded Access Protocol

Study Identifier:
ECU-COV-402
ClinicalTrials.gov Identifier:
NCT04802083
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Biological: Eculizumab
Date
N/A - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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 Criteria
  • Unresolved Neisseria meningitidis infection.
  • Known hypersensitivity to murine proteins or to an excipient of Soliris.
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Biological: Eculizumab
Date
N/A - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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 Criteria
  • Unresolved Neisseria meningitidis infection.
  • Known hypersensitivity to murine proteins or to an excipient of Soliris.

Protocol Summary

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

Trial Locations

No locations found.