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

Study Identifier:
ECU-COV-401
ClinicalTrials.gov Identifier:
NCT04355494
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other

Study Details

Medical Condition
  • Infections & Vaccines-Preventable Conditions - Other
  • 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 ≥ 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
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Infections & Vaccines-Preventable Conditions - Other
  • 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 ≥ 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

Protocol Summary

This protocol provides access to eculizumab treatment for participants with severe COVID-19.

Trial Locations

Location
Status
Location
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Status
N/A
Location
Boston Medical Center
Boston, Massachusetts, United States, 02118
Status
N/A
Location
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
Status
N/A
Location
Mayo Clinic
Rochester, Minnesota, United States, 55905
Status
N/A
Location
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Status
N/A
Location
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Status
N/A
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