Back to resultsSOLIRIS® (Eculizumab) Treatment of Participants With COVID-19
Primary Purpose
COVID-19, Pneumonia, Viral, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
eculizumab
Sponsored by
About this trial
This is an expanded access trial for COVID-19 focused on measuring acute lung injury, acute respiratory distress syndrome, antibodies, monoclonal, humanized, complement inhibition, COVID-19, eculizumab, emergency treatment, expanded access program, hospitalization, pneumonia, severe acute respiratory syndrome, severe acute respiratory syndrome coronavirus 2, severe pneumonia, Soliris, viral
Eligibility 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
Sites / Locations
- Cedars-Sinai Medical Center
- Boston Medical Center
- Newton-Wellesley Hospital
- Mayo Clinic
- Robert Wood Johnson University Hospital
- Icahn School of Medicine at Mount Sinai
- The Ohio State University Wexner Medical Center
- Hôpital Henri Mondor
- Hôpital Garches Raymond Poincaré
- Hôpital de Bicêtre
- Hôpital Saint Louis
- Hôpital Paul Brousse
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04355494
Brief Title
SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19
Official Title
SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID 19) - An Expanded Access Program for Hospital-based Emergency Treatment
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 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 access to eculizumab treatment for participants with severe COVID-19.
Detailed Description
This is an open label, multicenter, Expanded Access Program (EAP) to allow participants with a confirmed diagnosis of SARS-CoV-2 infection, and a clinical presentation consistent with COVID-19 severe pneumonia, acute lung injury, or ARDS to be treated with eculizumab. Participants admitted to a designated hospital facility who qualify for emergency treatment will be administered eculizumab up to 7 times during their treatment course (5 mandatory doses and up to 2 optional doses, per Investigator assessment).
The EAP consists of a Screening Period of up to 7 days, a 4-week Treatment Period, a final in-hospital assessment on Day 29 or day of discharge, whichever occurs first, and 3 monthly safety follow up visits (to be conducted as a telephone call if the participant has been discharged from the hospital or an in-person visit if the participant is still hospitalized).
For each participant, the total duration of the program is anticipated to be 4.5 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Pneumonia, Viral, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Keywords
acute lung injury, acute respiratory distress syndrome, antibodies, monoclonal, humanized, complement inhibition, COVID-19, eculizumab, emergency treatment, expanded access program, hospitalization, pneumonia, severe acute respiratory syndrome, severe acute respiratory syndrome coronavirus 2, severe pneumonia, Soliris, viral
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
eculizumab
Other Intervention Name(s)
Soliris
Intervention Description
Eculizumab at doses of 900-1200 mg will be administered intravenously (up to 7 doses)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Hôpital Garches Raymond Poincaré
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Hôpital de Bicêtre
City
Le Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Paul Brousse
City
Villejuif
ZIP/Postal Code
94800
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35514201
Citation
Burwick RM, Dellapiana G, Newman RA, Smithson SD, Naqvi M, Williams J 3rd, Wong MS, Bautista M, Gaden A, Kazani SD, Dunn DA, Ma MH, Mitter S, Monteleone JPR, Ortiz SR, Ghandehari S, Merin N, Zakowski MI, Karumanchi SA. Complement blockade with eculizumab for treatment of severe Coronavirus Disease 2019 in pregnancy: A case series. Am J Reprod Immunol. 2022 Aug;88(2):e13559. doi: 10.1111/aji.13559. Epub 2022 May 12.
Results Reference
derived
Learn more about this trial
SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19
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