Back to resultsCOVID-19 Soliris Expanded Access Protocol
Primary Purpose
Covid19
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Eculizumab
Sponsored by
About this trial
This is an expanded access trial for Covid19 focused on measuring 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
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04802083
Brief Title
COVID-19 Soliris Expanded Access Protocol
Official Title
SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID-19) - An Expanded Access Protocol
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexion
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
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
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Eculizumab
Other Intervention Name(s)
Soliris, monoclonal antibody
Intervention Description
Eculizumab 900-1200 mg will be administered intravenously.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
COVID-19 Soliris Expanded Access Protocol
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