SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19
NO_LONGER_AVAILABLE
Conditions studied: COVID-19, Pneumonia, Viral, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
In brief
This protocol provides access to eculizumab treatment for participants with severe COVID-19.
Key facts
- Study ID
- NCT04355494
- Run by
- Alexion Pharmaceuticals, Inc.
- Last updated by the study team
- 2021-03-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Boston Medical Center — Boston, Massachusetts, United States
- Newton-Wellesley Hospital — Newton, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
- Hôpital Henri Mondor — Créteil, France
- Hôpital Garches Raymond Poincaré — Garches, France
- Hôpital de Bicêtre — Le Kremlin-Bicêtre, France
- Hôpital Saint Louis — Paris, France
- Hôpital Paul Brousse — Villejuif, France
Full record on ClinicalTrials.gov
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