SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19
SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID 19) - An Expanded Access Program for Hospital-based Emergency Treatment
1 other identifier
expanded_access
N/A
2 countries
12
Brief Summary
This protocol provides access to eculizumab treatment for participants with severe COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2020
CompletedFirst Posted
Study publicly available on registry
April 21, 2020
CompletedMarch 9, 2021
March 1, 2021
April 17, 2020
March 5, 2021
Conditions
Keywords
Interventions
Eculizumab at doses of 900-1200 mg will be administered intravenously (up to 7 doses)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Hôpital Henri Mondor
Créteil, 94000, France
Hôpital Garches Raymond Poincaré
Garches, 92380, France
Hôpital de Bicêtre
Le Kremlin-Bicêtre, 94275, France
Hôpital Saint Louis
Paris, 75010, France
Hôpital Paul Brousse
Villejuif, 94800, France
Related Publications (1)
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.
PMID: 35514201DERIVED